Joint aspirate facilitating device and method

Abstract

A joint aspiration and pain relief kit that includes a cuff having a main panel with an outer side and an inner side. An inflation pump is configured to inflate the cuff. An inflatable bladder is located between the inner and the outer side, with the bladder configured to compress at least one fluid sac of a joint when inflated by the cuff inflation pump. A plurality of pockets are located on the inner side and configured to receive a respective plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device. Temperature therapy circulation tubing is located between the inner and the outer side is are configured to receive heated or cooled fluid. At least one access opening is provided in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint.

Description

JOINT ASPIRATE FACILITATING DEVICE AND METHODRelated Application Data

[0001] This Application is related to U.S. Patent 7,468,048, entitled "Joint aspirate facilitating device," issued on December 23, 2008, which is incorporated herein by reference in its entirety.Field

[0002] One exemplary aspect of the disclosed technology relates to orthopedic devices used to facilitate healing and / or perform a medical procedure on a joint, and more particularly, to an orthopedic appliance for facilitating one or more of aspiration of joint fluid, or injection of therapeutic agents, inducing transcutaneous electrical nerve stimulation and / or applying heat and / or cold therapy to a joint such as a knee, elbow or other joint such on a human or other animal patient, to reduce procedural pain.Background

[0003] There are numerous orthopedic appliances that are used to support or immobilize various body parts. With respect to stabilizing or immobilizing the knee joint because of an injury, some of these orthopedic appliances include the use of inflatable air bladders for intermittently supporting and / or releasing support on the knee. Some examples of these devices, which are all incorporated by reference herein in their entirety, include an inflatable knee brace such as U.S. Patent No. 3,983,056, which describes inflatable tubes stitched into a fabric support extending vertically over a portion of the support. U.S. Patent No. 4,430,042 describes a pillow type device strapped to the leg of a patient and then inflated. U.S. Patent No. 4,872,448 discloses a U-shaped inflatable bladder placed over the patella. U.S. Patent No. 4,938,207 describes a linear brace employing first and second fluid filled chambers. U.S. Patent No. 4,947,834 describes a brace for compressing a patient's outer extremities, the brace including flexible chambers arranged in a series that are then successively inflated. U.S. Patent No. 4,960,115 describes a body support apparatus having at least two inflation chambers. U.S. Patent No. 5,626,557 discloses a knee brace having inflatable supports extending longitudinally on both sides of the knee.

[0004] The knee is one of the more common joints that is aspirated for purposes of diagnosing ailments of the joint. Such ailments may include infections, inflammatory or crystal arthritis, and others. The knee joint is also commonly aspirated for purposes of administering pharmaceutical agents into the knee joint such as, for example, glucocorticoids, visco-supplements and / or biological therapeutics. A medical practitioner attending to a patient having a knee joint ailment typically requires the practitioner to have certain skills in aspirating the knee, and a medical specialist such as an orthopedic surgeon or rheumatology specialist typically performs knee and other joint aspirations. A general practitioner rarely conducts knee aspirations without additional training. Accordingly, increased costs may be incurred because a medical specialist is typically required to conduct the procedure. Even with experienced specialists or doctors, knee aspirations can be difficult to perform because there is a very small area in which the aspirating needle can be inserted in the joint without striking pain-sensitive structures including bone, ligaments or the like.Summary

[0005] Therefore, there is a need to provide a device that at least eases the complexity, cost and challenges in performing a joint or knee aspiration procedure, thereby increasing the odds of successfully performing the aspiration without inadvertently contacting surrounding tissue or bone, while at the same time also potentially reducing risk, discomfort, pain and cost. There is also a need to provide a new device that allows general practitioners or other non-specialists to perform the procedure by increasing the size of the area where the needle may be inserted to penetrate the fluid sac surrounding the joint, such as a knee.

[0006] With respect to the prior art discussed above, while a number of inflatable knee brace configurations are known, none of the prior art devices provide adequate functionality for facilitating a joint aspiration procedure as disclosed herein.

[0007] In order to overcome one or more of the various disadvantages inherent in conducting joint aspiration procedures, and to overcome the failure of the prior technology to address such needs, an exemplary embodiment relates to a joint aspirate-facilitating device or cuff that at least provides enhanced capabilities for a medical practitioner to successfully perform a joint aspiration procedure. This can be coupled with one or more oftranscutaneous electrical nerve stimulation (TENS) electrodes for TENS therapy, heat / cold therapy and pressure applied through an inflatable bladder in the cuff.

[0008] The cuff can be made a multi-layer construction including a flexible (optionally partially stretchable), cloth-like material that incorporates an inflatable bladder. The cuff can have one or more attachment mechanisms such as hook-and-loop for securing the cuff to a patient. The cuff can also have pockets for the TENS electrodes, one or more markers or fiducia Is to assist with imaging and one or more topical analgesic compartment(s) to assist with the application of and / or maintaining of a topical analgesic against a portion of the joint.

[0009] The bladder can be specially sized, shaped and positioned (and can be multicompartment, with each compartment optionally being individually controlled to increase / decrease pressure) to place pressure on specific region(s) of a joint to thereby displace distended joint fluid into a targeted location. The volume and pressure of the joint fluid is increased at the targeted location thereby increasing the size and pressure of the fluid sac where the aspirating needle can be placed through the access opening or targeting opening to successfully aspirate the joint.

[0010] In a first aspect, the cuff can resemble a traditional knee support or brace, but adopts a plurality of unique structural features to facilitate not only a successful aspiration procedure, but also further therapeutic benefits. Specifically, the inflatable bladder can be located to displace joint fluid from, in the case of the knee, the contra lateral, superior, inferior and posterior joint regions towards a targeted location to facilitate fluid removal. An access opening(s) is present in the cuff at the targeted location(s). The aspirating needle penetrates the joint at the access opening, and the increased volume and pressure of the fluid located at the opening(s) greatly enhances the ability of the practitioner to successfully penetrate the fluid sac to extract the fluid. The access opening(s) is preferably located either on the medial or lateral side of the knee joint, and is oriented to allow the medical practitioner to specifically access the suprapatellar bursae from the medial or lateral side. The size and shape of this / these access openings can be varied based on one or more of, for example, the size of the cuff, the type of procedure being performed and / or other factors such as accessibility and the joint on which the procedure is being performed. As such, numerous cuffs can be made that are specifically configured based on the joint on which thecuff will be used. Each of these cuffs could have different placements, sizes and shapes of any one or more of the features discussed herein, and can be configured as a kit with different joint-specific cuffs. The cuff can also be used in a flexed knee position for example to accommodate patients in a wheelchair, or the like.

[0011] The cuff can optionally include a lightweight, washable fabric with a removable inflatable bladder controlled by an external, hand-operated and / or electric pump(s) to selectively pressurize the bladder(s) (or one or more bladders if the cuff is made with multiple, separately inflatable sections). A pressure release element(s) or valve(s) and pressure gauge(s) can also be provided to release or adjust pressure in one or more of the bladders. A pressure gauge(s) may be incorporated with one or more of the pumps to allow the practitioner to monitor the amount of pressure applied to the joint. An internal pocket may be formed on an inner side of the cuff placed against the patient. The bladder can be secured in this pocket during use. The bladder when deflated can optionally be removed from the pocket to allow the device to be washed or otherwise serviced. A closure element, such as hook and loop material or comparable closure mechanism, may be used to secure both the internal bladder(s) to the pocket(s) as well as to secure the device around the joint.

[0012] The cuff can also optionally include a disposable sterile field dressing to minimize risk of inadvertent inoculation of bacteria into the sterile cavity of the joint. In yet another optional aspect, the access opening(s) formed in the cuff can be used in a non- interventional procedure such as an ultrasound procedure to visualize the tissue located at the access opening. The cuff may also optionally include sleeves formed on the outer surface thereof to hold an ultrasound probe that is positioned at the access opening. Additionally, the cuff can include one or more pockets placed anywhere on the cuff for the holding of electrodes for TENS therapy, with these electrodes being removable.

[0013] In an optional knee-joint specific aspect, a single access opening can be provided at either a medial or a lateral location for aspirating the knee joint. In another illustrative aspect, a complementary access opening(s) can be provided at the medial and lateral locations, and depending whether a medial or lateral approach is taken, the unused access opening can optionally be blocked with a plug or pressure inducing closable flap thereby encouraging fluid displacement from the opposite side of the joint.

[0014] Exemplary aspects are also disclosed for use of the cuff for other joints to include the wrist, elbow, and ankle. With these other uses for other joints, the basic principle and benefits of the technology can be maintained: selective locational displacement of distended joint fluid to a targeted location, access opening(s) at the targeted location, topical analgesic windows, TENS therapy electrode compartments and / or imaging assistance fiducia Is and the like as discussed herein.

[0015] Depending on the construction of the bladder or bladders, one portion of the inflatable bladder can optionally substantially encircle the joint when installed and the bladder therefore can have a generally curved configuration that, for example, can optionally have a specific shape depending on the joint on which the procedure(s) is being performed. For exemplary implementations of the cuff for use with the ankle, knee and wrist joints, a main portion of the inflatable bladder may be generally cylindrical in shape when installed and inflated around the joint.

[0016] With the joint aspiration cuff, the increased volume and pressure of the fluid to be aspirated increases the effective size of the targeted area, thereby reducing the chance that the aspirating needle will strike bone or will strike unintended tissue such as nerves, fat pad, meniscus, or tendons. The cuff can of course be made in various sizes to accommodate joint sizes encountered with adults, children, or obese patients. And the cuff can be modified to fit various other animals such as horses, dogs, cats, etc.

[0017] Coupling this cuff structure with analgesic, TENS therapy and / or hot / cold therapy can also be used to assist in patient comfort during the procedure and directly or indirectly also assist with managing patient comfort / discomfort and pain. Since TENS therapy and or hot / cold therapy can be used to distract a patient during a procedure, these can indirectly reduce perceived pain during a procedure. Additionally, hot / cold therapy can also assist with inflammation reduction that can be further used to facilitate success of the procedure.

[0018] The addition of fid ucia Is can also assist with various imaging techniques to facilitate aspiration through successful needle guidance, and also assist with placement of the cuff on a patient.

[0019] The cuff could also be used to reduce pain during joint lavage procedures, radiofrequency / laser ablation procedures, genicular artery embolization, used to reduceinflammation and joint pain and / or for molecular endotyping using synovial biopsies to identify the best therapeutic agent for a specific patient (precision medicine).

[0020] These and other features and advantages of the invention will become apparent from review of the following drawings, taken in conjunction with the detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The exemplary embodiments of the invention will be described in detail, with reference to the following figures, wherein:

[0022] Fig. 1 illustrates an exemplary cuff according to a first aspect;

[0023] Fig. 2 is an environmental view of the exemplary cuff; and

[0024] Fig. 3 is a flowchart illustrating an exemplary method of using the cuff.DETAILED DESCRIPTION

[0025] The exemplary embodiments of this invention will be described in relation to a cuff having one or more optional features.

[0026] While the invention is described in terms of exemplary embodiments, it should be appreciated that individual aspects of the invention could be separately and individually claimed and any one or more of the features of the various embodiments can be combined.

[0027] Fig. 1 illustrates an exemplary cuff 1. The cuff includes a main panel 3, with first and second transverse edges 2 that interest first and second longitudinal edges on straps 4. These straps 4 can include one or more securing mechanisms such as hook-and- loop fasteners 8, buttons, snaps, ties, or comparable securing mechanism(s) to facilitate securing of the cuff to a joint.

[0028] The cuff 1 while illustrated as having a rectangular main panel 2, can have a main panel 2 of any shape and size and can have curved or curvilinear transverse edges 2, and similarly can have curved or other non-rectangularly shaped straps 4. The sizes and shapes of the main panel and straps can be varied, for example, bason on the joint to which the cuff is intended to be used.

[0029] The cuff 1 can be made of various layers 16 that are secured together such as by sewing, gluing, ultrasonic welding, or the like, to hold one or more inflatable bladders 20. Additionally, the layers can include one or more of: a cloth, cotton, elastic material, latex, silicone, or in general any material suitable for cuffs. For example, the cuff 1 can include a cloth material on the innermost side that is placed against a patient's skin, an inner latex or elastic material that holds the inflatable bladder(s) 20 and an elasticized outer covering.

[0030] While the bladder 20 is shown as an (generally rectangular) singular bladder that surrounds the access port 86 and analgesic compartment 74, it is to be appreciated that the cuff 1 can include one or more inflatable bladders of different sizes and shapes placed anywhere in the cuff 1. As discussed hereinafter, the bladder(s) could also be located between the tubing 70 that carries the fluid from the circulation pump 58 that enables hot / cold therapy. The bladder 20 itself can also be made of multiple layers and can comprise rubber, latex, silicone, foil, plastic, mylar, and / or any other suitable material(s).

[0031] From innermost side to outermost side, the construction of the main panel 2 could be, as one example, elasticized cloth-flexible material-bladder(s)-flexible material- elasticized cloth material. Alternatively, or in addition, one or more of the bladders could be placed on an innermost side of the cuff 1. Similarly, the tubing 70 (discussed hereinafter) can be located between one or more layers of the cuff and / or on an innermost or outermost side of the cuff.

[0032] One or more of an electric 22 and a manual 38 air pump are connectable via a hose(s) 30 to the bladder(s) 20 via an air fiting (not shown) that can optionally include a valve 26. The air pumps can have a pressure gauge(s) 34 configured to monitor pressure in one or more of the bladder(s) 20. One or more of an electric 22 and a manual 38 air pump are configured to inflate the one or more of the bladders to apply pressure to the joint to facilitate aspiration. Optionally, the fiting on the cuff can have an internal valve such that the pump(s) can be disconnected from the cuff while still maintain pressure in the cuff.

[0033] The bladder 20 can also be filled with a viscous material such as a gel material, and pressurization of the joint would therefore occur without necessarily the need for the pumps 22 / 38. The particular viscosity and amount of the gel material can be chosen to apply a selected amount of pressure to the joint. For routine aspirations, it is possible toprovide a bladder 20 filled with the gel material to generate adequate pressure for displacing the joint fluid.

[0034] Included in the main panel 2 are one or more access ports 86 (not shown to scale) that can be placed anywhere in the cuff. As discussed, access ports 86 can be a single access opening that can be provided at either a medial or a lateral location for aspirating the knee joint. Additionally, complementary access openings can be provided at the medial and lateral locations of the main panel 2, and depending whether a medial or lateral approach is taken, the unused access opening can optionally be blocked with a plug or pressure inducing closable flap (not shown) thereby encouraging fluid displacement from the opposite side of the joint.

[0035] Tubing 70 can also be integrated into the cuff 1 and placed within or on the layers 16. This tubing is connectable to a circulation pump 58 and heating / cooling system 62. The heating / cooling system 62 can heat or cool a fluid that is circulated through the tubing 70. This can assist with one or more of inflammation and or pain relief / management. While not shown, the tubing of the cuff can include a valve and coupling mechanism to attached the circulation pump 58 and heating / cooling system 62 to the cuff 1 while preventing fluid escape. The tubing 70 facilitates transfer of a heated or cooled fluid through the cuff 1 and around the joint. The tubing can have any pattern or layout and can be included in one or more of the main body 2 and straps 4 of the cuff 1. The tubing 70 can be configured in a loop thereby allowing fluid circulation through the cuff 1. The tubing can be any suitable material such as rubber, latex, silicone, plastic and / or the like.

[0036] One or more of the main panel 2 and straps 4 can also include fiducia Is 82 to assist with imaging and / or securing of the cuff to the joint. These fid ucia Is 82 can be of any suitable material, size, shape and placement on the main panel to facilitate imaging and / or placement of the cuff on the joint. For example, instructions can be provided with the cuff that allow a technician to rapidly and accurately place the cuff of a joint by placing a specific fiducial at a specific point on the joint.

[0037] The fiducia l(s) 82 can also include a human visible marking on the exterior surface of the cuff 1 and conforming in location and shape to the underlying kneecap when the device is installed. This alignment indicator helps the practitioner position the device on the joint so that the access opening 86 is located at an optimal position for the aspiration.This visible fiducial 82 can optionally be centered over the kneecap for proper device alignment. Alternatively, the fiducial 82 can define another opening formed in the main panel 2 to expose the kneecap that allows the medical provider to properly align the aspirating device. Alternatively, or additionally, the fiducial 82 can be a patch of thinner material and / or transparent material that allows the practitioner to better fee l / see the location of the kneecap in order to properly align the device. This thinner material can include a clear flexible plastic material that also allows the practitioner to view the kneecap.

[0038] One or more pouches 54 can also be located anywhere on the cuff to accommodate electrode(s) 50. The electrode(s) 50 are connected via wires 46 to a TENS device 42. The TENS device 42 can provide a massaging or other vibration pattern that includes one or more of a change in amplitude and / or frequency applied to the electrode(s). This can optionally be combined with varying a duration and a pressure applied to the inflatable cuff via the air pump 22. Alternatively, or additionally, this can be combined with temperature therapy from the circulation pump 58 and heating cooling system 62. The TENS device 42 unit is a powered device with the associated electrodes 50 that deliver electrical impulses through the surface of a patient's skin. While a doctor can place the electrodes at or near trigger points (muscle knots) or affected nerves, having pockets to accommodate the electrodes placed at known locations on the cuff corresponding to trigger points on the joint makes installation of the cuff and electrodes faster, easier and more accurate.

[0039] The cuff 1 can also include one or more areas 74 configured to receive an analgesic, here shown for illustrative purposes around where the kneecap 78 would be located upon securing the cuff to a patient. This area 74 can be a compartment configured to hold a topical analgesic compartment or allow application of a topical analgesic. This compartment can be configured to receive an analgesic and hold the topical analgesic against a portion of a joint. While the topical analgesic compartment is shown circular and proximate to the kneecap, it is to be appreciated that the topical analgesic compartment 74 can be any size, shape and / or placed at any location on the cuff. There can also be multiple topical analgesic compartments on the cuff to facilitate topical analgesic administration to a joint. Alternatively, or in addition, the areas 74 need not be compartments but could alternatively be openings in the cuff that allow application of an analgesic. These additionalopenings in the main panel are configured to allow easy access to a patient's skin for the administration of one or more topical analgesics for patient pain management.

[0040] The cuff 1 also includes one or more access openings 86. The access openings 86 are located at a target area(s) where joint fluid is to be aspirated from the joint. The access opening 86 can be formed in the main panel 2, and provides a targeting area where an aspirating needle is placed to aspirate fluid from the distended fluid-filled joint cavity. The opening 86 is defined by an edge that can be of any size, shape, or location on the cuff 1. Specifically, the access opening 86 can be sized and shaped to best locate the desired portion of the joint to be aspirated. The access opening 86 can be located either on the medial or lateral sides of the joint (or both), depending upon which leg the device is affixed to. Alternatively, or in addition, a single access opening could be located on the opposite medial or lateral side of the joint and accordingly, the orientation of the inflatable bladder would be reversed to accommodate the new location of the access opening. Thus, both medial and lateral sides of the knee joint for both the left and right legs can be exposed for aspiration through the selected position of the access opening. Medial and lateral side access openings can also both be provided in the cuff simultaneously.

[0041] Alternatively, or in addition, the access opening(s) 86 may be used for not only aspirating the joint, but for also conducting other invasive or non-invasive procedures. For example, prior to conducting the aspirating procedure, it may be desirable to confirm that the area exposed for aspiration at the access opening 86 does in fact contain fluid. Accordingly, a non-invasive procedure such as an ultrasound may be conducted where an ultrasound probe is placed on the patient at the access opening 86. While not illustrated, the cuff 1 can be used with an ultrasound system. Sleeves or pockets (not shown) can optionally formed in the main panel 2 to accept an ultrasound probe which can be used to visualize tissue at the access opening 86.

[0042] Fig. 2 provides an exemplary environmental perspective view of the cuff 1 placed on a patent's knee. Here the location of the knee cap and access port 86 relative to the knee cap can be seen, with the access port facilitating fluid extraction from a correct location on the joint.

[0043] Fig.3 outlines an exemplary method of using the cuff. The methodology begins in step S100 and continues to step S104. In step S140, the cuff is secured to a joint.Next, in step S108, one or more of pneumatic pumps and gauges are connected to the cuff. Then, in step S112, one or more fluid pumps and heating / cooling systems are connected to the cuff to supply temperature therapy. Control then continues to step S116.

[0044] In step S116, one or more electrodes in the cuff are connected to a TENS device. And in step S120, the location of the cuff on the joint can be verified through visualizing one or more fiducials with the huma eye and / or with the aid of an imaging device such as an x-ray machine, ultrasound, CT scan, or the like. Control then continues to step S124.

[0045] In step S124, the one or more bladders in the cuff are inflated and pressures adjusted to facilitate the procedure being performed. Next, and optionally in step S128, and optionally in conjunction with or separate from the inflation of the bladder(s), one or more of hot / cold temperature therapy, TENS therapy and application of a topical analgesic are performed. Then, in step S132, the access opening(s) are used to guide a needle to facilitate fluid extraction, or therapeutic agent, with non-used access openings optionally being secured and imaging techniques optionally being employed to facilitate needle placement. Control then continues to step S136.

[0046] On step S136, one or more of TENS therapy, temperature therapy and / or topical analgesic treatment is performed / continued. Next, in step S140, and upon completion of the procedure(s), the cuff is deflated and removed with the process continuing to step S144 where the procedure ends.

[0047] Therefore, one or more of the aspects of the technology discussed herein are directed to:A device configured to assist with a joint aspiration comprising: a cuff including a main panel with first and second transverse edges, and first and second longitudinal edges; the cuff further including an inflatable portion, the inflatable portion configured to compress at least one fluid sac of a joint; the cuff further including locations configured to accept one or more additional components; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint, the at least one access opening located ina gap between a pair of extensions, the extensions terminating adjacent the at least one access opening such that the extensions do not encircle the access opening; and a closure secured to at least one of said first and second longitudinal edges configured to secure the device to the joint.Any one or more of the above aspects, wherein the inflatable portion is secured to an interior side of the main panel.Any one or more of the above aspects, wherein the inflatable portion incudes: a main portion with a generally curved or curvilinear configuration, a pair of transverse extensions extending from the main portion, and a converging area located between the pair of extensions and the main portion, the portion extending between the longitudinal edges of the main panel.Any one or more of the above aspects, wherein the transcutaneous electrical nerve stimulation device varies one or more of an amplitude and frequency of a current that is supplied to the joint to one or more of block pain and change a patient perception of pain. Any one or more of the above aspects, wherein the cuff further includes one or more of a circulation portion and circulation tubing configured to receive heated or cooled fluid.Any one or more of the above aspects, wherein one or more of the circulation portion and circulation tubing are connected to a circulation pump and fluid temperature regulating device, the circulation pump configured to provide a pulsating rhythm to the heated or cooled fluid.Any one or more of the above aspects, wherein the cuff further includes a topical analgesic compartment.Any one or more of the above aspects, wherein the cuff further includes an area configured to receive an analgesic.Any one or more of the above aspects, wherein the cuff further includes one or more of a circulation portion and circulation tubing configured to receive heated or cooled fluid, and the one or more additional components include one or more of: a plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device, and an ultrasound probe.Any one or more of the above aspects, wherein the cuff further includes additional openings in the main panel configured to allow the administration of one or more of: one or more analgesics and anesthetic agents.Any one or more of the above aspects, further comprising one or more markers configured to assist with imaging.Any one or more of the above aspects, wherein the inflatable portion is configured to receive one or more of pressurized air, a heated or cooled fluid, and a heated or cooled pressurized fluid.Any one or more of the above aspects, further comprising a circulation pump, the transcutaneous electrical nerve stimulation device and a fluid temperature regulating device.Any one or more of the above aspects, further comprising a controller configured to adjust a pressure in the inflatable cuff to provide a massaging vibration pattern.Any one or more of the above aspects, wherein the massaging vibration pattern includes one or more of a change in amplitude and duration of a pressure applied to the inflatable cuff.Any one or more of the above aspects, further comprising a pump connectable to the inflatable portion via a valve assembly.A device configured to assist with one or more of joint aspiration, joint injection and pain relief comprising: a cuff including a main panel with an outer side and an inner side; an inflatable portion located between the first and the second side, the inflatable portion configured to compress at least one fluid sac of a joint when inflated; a plurality of attachment points located on the inner side and configured to receive a respective plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint; and a closure secured to the outer side and configured to secure the device to a patient.The device of claim 16, further including one or more of a circulation portion and circulation tubing located between the inner and the outer side and configured to receive heated or cooled fluid.Any one or more of the above aspects, wherein one or more of the circulation portion and circulation tubing are connected to a circulation pump and fluid temperature regulating device.Any one or more of the above aspects, further comprising one or more of: a controller configured to adjust a pressure in the inflatable cuff to provide a massaging vibration pattern; and one or more transducers configured to provide a massaging vibration pattern.A joint aspiration and pain relief kit comprising: a cuff including a main panel with an outer side and an inner side; a cuff inflation pump; an inflatable portion located between the first and the second side, the inflatable portion configured to compress at least one fluid sac of a joint when inflated by the cuff inflation pump; a plurality of attachment points located on the inner side and configured to receive a respective plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device; one or more of one or more circulation portions and circulation tubing located between the inner and the outer side and configured to receive heated or cooled fluid; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint; and a closure configured to secure the cuff to a patient.A device configured to assist with delivery of one or more therapeutic agents to a joint comprising: a cuff including a main panel with first and second transverse edges, and first and second longitudinal edges; the cuff further including an inflatable portion; at least one access opening in the main panel, the access opening located at a target area where the one or more therapeutic agents are to be provided, the at least one accessopening located in a gap between a pair of extensions, the extensions terminating adjacent the at least one access opening such that the extensions do not encircle the access opening; and a closure secured to at least one of said first and second longitudinal edges configured to secure the device to the joint.Any one or more of the above aspects, wherein the one or more therapeutic agents are one or more of small molecules, visco-supplements, antibodies, cell and gene therapies, biological therapeutics, stem cells, and glucocorticoids.A method comprising: securing a cuff to a joint; applying one or more of TENS therapy, temperature therapy and a topical analgesic to the joint; inflating one or more bladders in the cuff; and using an access opening to guide a needle into the joint to extract a fluid.Any one or more of the above aspects, further comprising using an imaging device to visualize one or more fiducia Is on the cuff.Any one or more of the above aspects, further comprising deflating and removing the cuff from the joint upon completion of a procedure.

[0048] Although the present disclosure describes components and functions implemented in the aspects, embodiments, and / or configurations with reference to particular procedures and techniques, the aspects, embodiments, and / or configurations are not limited to such procedures and techniques and the cuff can be used in other ways as will be appreciated by one of ordinary skill in the art. Other similar procedures and techniques not mentioned herein are in existence and are considered to be included in the present disclosure. Moreover, the procedures and techniques mentioned herein and other similar procedures and techniques not mentioned herein are periodically superseded by faster or more effective equivalents having essentially the same functions. Such replacement procedures and techniques having the same functions are considered equivalents included in the present disclosure.

[0049] The present disclosure, in various aspects, embodiments, and / or configurations, includes components, methods, processes, systems and / or apparatussubstantially as depicted and described herein, including various aspects, embodiments, configurations embodiments, subcombinations, and / or subsets thereof. Those of skill in the art will understand how to make and use the disclosed aspects, embodiments, and / or configurations after understanding the present disclosure. The present disclosure, in various aspects, embodiments, and / or configurations, includes providing devices and processes in the absence of items not depicted and / or described herein or in various aspects, embodiments, and / or configurations hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and\or reducing cost of implementation.

[0050] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate exemplary aspect of the disclosure.

[0051] Moreover, though the description has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0052] It is therefore apparent that there has been provided, in accordance with the present invention, systems and methods for a new and improved joint cuff. While this technology has been described in conjunction with a number of embodiments, it is evident that many alternatives, modifications and variations would be or are apparent to those of ordinary skill in the applicable arts. Accordingly, it is intended to embrace all such alternatives, modifications, equivalents and variations that are within the spirit and scope of this disclosure.

Claims

Claims:

1. A device configured to assist with a joint aspiration comprising: a cuff including a main panel with first and second transverse edges, and first and second longitudinal edges; the cuff further including an inflatable portion, the inflatable portion configured to compress at least one fluid sac of a joint; the cuff further including locations configured to accept one or more additional components; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint, the at least one access opening located in a gap between a pair of extensions, the extensions terminating adjacent the at least one access opening such that the extensions do not encircle the access opening; and a closure secured to at least one of said first and second longitudinal edges configured to secure the device to the joint.

2. The device of claim 1, wherein the inflatable portion is secured to an interior side of the main panel.

3. The device of claim 1, wherein the inflatable portion incudes: a main portion with a generally curved or curvilinear configuration, a pair of transverse extensions extending from the main portion, and a converging area located between the pair of extensions and the main portion, the portion extending between the longitudinal edges of the main panel.

4. The device of claim 1, wherein the transcutaneous electrical nerve stimulation device varies one or more of an amplitude and frequency of a current that is supplied to the joint to one or more of block pain and change a patient perception of pain.

5. The device of claim 1, wherein the cuff further includes one or more of a circulation portion and circulation tubing configured to receive heated or cooled fluid, andthe one or more additional components include one or more of: a plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device, and an ultrasound probe.

6. The device of claim 5, wherein one or more of the circulation portion and circulation tubing are connected to a circulation pump and fluid temperature regulating device, the circulation pump configured to provide a pulsating rhythm to the heated or cooled fluid.

7. The device of claim 1, wherein the cuff further includes a topical analgesic compartment.

8. The device of claim 1, wherein the cuff further includes an area configured to receive an analgesic.

9. The device of claim 1, wherein the cuff further includes additional openings in the main panel configured to allow the administration of one or more of: one or more analgesics and anesthetic agents.

10. The device of claim 1, further comprising one or more markers configured to assist with imaging and / or placement of the device.

11. The device of claim 1, wherein the inflatable portion is configured to receive one or more of pressurized air, a heated or cooled fluid, and a heated or cooled pressurized fluid.

12. The device of claim 1, further comprising a circulation pump, the transcutaneous electrical nerve stimulation device and a fluid temperature regulating device.

13. The device of claim 1, further comprising a controller configured to adjust a pressure in the inflatable cuff to provide a massaging vibration pattern.

14. The device of claim 13, wherein the massaging vibration pattern includes one or more of a change in amplitude and duration of a pressure applied to the inflatable cuff.

15. The device of claim 1, further comprising a pump connectable to the inflatable portion via a valve assembly.

16. A device configured to assist with one or more of joint aspiration, joint injection and pain relief comprising: a cuff including a main panel with an outer side and an inner side; an inflatable portion located between the first and the second side, the inflatable portion configured to compress at least one fluid sac of a joint when inflated; a plurality of attachment points located on the inner side and configured to receive a respective plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint; and a closure secured to the outer side and configured to secure the device to a patient.

17. The device of claim 16, further including one or more of a circulation portion and circulation tubing located between the inner and the outer side and configured to receive heated or cooled fluid.

18. The device of claim 17, wherein one or more of the circulation portion and circulation tubing are connected to a circulation pump and fluid temperature regulating device.

19. The device of claim 16, further comprising one or more of: a controller configured to adjust a pressure in the inflatable cuff to provide a massaging vibration pattern; and one or more transducers configured to provide a massaging vibration pattern.

20. A joint aspiration and pain relief kit comprising: a cuff including a main panel with an outer side and an inner side; a cuff inflation pump; an inflatable portion located between the outer and the inner side, or located on the inner side, the inflatable portion configured to compress at least one fluid sac of a joint when inflated by the cuff inflation pump; a plurality of attachment points located on the inner side and configured to receive a respective plurality of electrodes, the electrodes connectable to a transcutaneous electrical nerve stimulation device; one or more of one or more circulation portions, compartments and circulation tubing located between the inner and the outer side and configured to receive heated or cooled fluid; at least one access opening in the main panel, the access opening located at a target area where joint fluid is to be aspirated from the joint; and a closure configured to secure the cuff to a patient.

21. A device configured to assist with delivery of one or more therapeutic agents to a joint comprising: a cuff including a main panel with first and second transverse edges, and first and second longitudinal edges; the cuff further including an inflatable portion; at least one access opening in the main panel, the access opening located at a target area where the one or more therapeutic agents are to be provided, the at least one access opening located in a gap between a pair of extensions, the extensions terminating adjacentthe at least one access opening such that the extensions do not encircle the access opening; and a closure secured to at least one of said first and second longitudinal edges configured to secure the device to the joint.

22. The device of claim 21, wherein the one or more therapeutic agents are one or more of small molecules, visco-supplements, antibodies, cell and gene therapies, biological therapeutics, stem cells, and glucocorticoids.

23. A method comprising: securing a cuff to a joint; applying one or more of TENS therapy, temperature therapy and a topical analgesic to the joint; inflating one or more bladders in the cuff; and using an access opening to guide a needle into the joint to extract a fluid.

24. The method of claim 23, further comprising using an imaging device to visualize one or more fiducials on the cuff.

25. The method of claim 23, further comprising deflating and removing the cuff from the joint upon completion of a procedure.

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