device

Abstract

The present disclosure relates to a mechanical device for administering pressure to a prostate, the device comprising an arm having a handle at a proximal end, and a finger mechanically coupled to a distal end of the arm via a knuckle joint, the knuckle joint arranged to angle the finger relative to the arm, such that, in use, actuation of the device moves the finger toward the prostate, from an insertion position to an application position; and in the application position, the finger applies pressure to the prostate.

Description

[0001] DEVICE

[0002] Field of the Invention

[0003] The present invention relates to a device for the treatment of conditions of the prostate, including prostatitis. The invention also relates to use of the device, to methods of diagnosis and treatment using the device.

[0004] Background to the Invention

[0005] The prostate is a small, rubbery gland about the size of a ping-pong ball, located deep inside the groin, between the base of the penis and the rectum. It is important for reproduction, because it supplies part of the seminal fluid (semen), which mixes with sperm from the testes. Seminal fluid helps the sperm to travel and survive. Of the problems affecting the prostate, one of the most common is chronic prostatitis.

[0006] Chronic prostatitis results from a series of inflammatory reactions in the prostate gland that, in turn, affect the entire genitourinary system. In the majority of chronic prostatitis cases, the cause is microbial with many microorganisms implicated, including coliforms, enterococci, staphylococci, proteus, chlamydia, ureaplasma, and mycoplasma.

[0007] Approximately 50% of males will show symptoms related to chronic inflammation of the prostate at some point in their lives. Symptoms depend on the speed at which inflammatory lesions evolve and spread in the prostate tissue; the type and quantity of microbes in the prostate; the precise area affected; and the effectiveness of the protective mechanisms in the tissue gland.

[0008] Nearly 70% of chronic prostate inflammation cases seen in urological surgeries are accompanied by side effects such as urethral stricture, leading to difficulty in urinating, sperm infertility due to the toxic effect of the inflammation on the production and quality of sperm, erectile dysfunction due to the impact of inflammation in the erectile nervous system, increased prostate size, and increased likelihood of tumour tissue.

[0009] Options for treatment of prostatitis and alleviation of symptoms are currently limited pain relief and anti-inflammatories. Although routinely prescribed, antibiotics are frequently ineffective. Alternative therapies such as warm baths, kegel exercises and acupuncture may be used to ease symptoms but they do not attempt to treat the underlying cause. Prostate massage is an alternative treatment, performed by a qualified healthcare provider, that involves the gentle massaging of the prostate gland through the rectum. It is sometimes used as a treatment approach for chronic bacterial prostatitis to help express prostatic fluid and potentially aid in the clearing of infection.

[0010] Georgiadis chronic prostatitis protocol (GCPP) uses finger compression gland therapy to break the hard and organised foci of inflammations in the prostate, remove obstructions in the prostatic glandular ducts, release strangulated nerves, allow the smooth flow of the prostatic fluid in glandular tubes, restore microvascular circulation in the glandular tissue, remove microbial cores, and restore a correct immune response to the healthy prostate glandular tissue. This therapy takes place over several monthsand is performed by a specialist, Dr Pavlos Georgiadis, using rigorous and pinpoint pressure to the prostate alongside antibiotics, including intraprostatic antimicrobial injections.

[0011] Unfortunately, GCPP is not scalable and is therefore accessible to only a few patients. It is against this backdrop that the present inventors have devised the disclosed device, with a view to making GCPP available to the wider population and for home therapy.

[0012] Summary of the Invention

[0013] The present disclosure relates to a mechanical device for use in the treatment of prostatitis. The device may be considered to be a wellness device.

[0014] According to a first aspect there is provided a mechanical device for administering a therapeutic amount of pressure to a prostate, the device comprising an arm having:

[0015] a handle at a proximal end, and

[0016] a finger mechanically coupled to a distal end of the arm via a knuckle joint, the knuckle joint being driven by a knuckle joint mechanism, wherein the knuckle joint is operable to bend the finger relative to the arm, such that, in use, actuation of the knuckle joint bends the finger toward the prostate, from an insertion position to an application position; and in the application position, the finger applies a therapeutic amount of pressure to the prostate.

[0017] In a second aspect there is provided a method of treating a prostate-condition selected from: prostatitis, benign prostate hyperplasia, or chronic pelvic pain syndrome (CPPS) with the device according to the present disclosure, comprising the steps:

[0018] (i) with the finger in the insertion position, insert finger into the rectum, position close to the prostate,

[0019] (ii) actuate the knuckle joint to bend the finger into the application position such that it applies pressure to the prostate,

[0020] (iii) release the pressure, and

[0021] (iv) optionally repeat steps (i)-(iii).

[0022] In a third aspect there is provided a method of diagnosing prostatitis, benign prostate hyperplasia, or chronic pelvic pain syndrome (CPPS) using the device disclosed herein.

[0023] In a fourth aspect there is provided the use of the device according to the present disclosure in the treatment of prostatitis, benign prostate hyperplasia, or CPPS.

[0024] In a further aspect there is provided a mechanical device for administering pressure to a prostate, the device comprising an arm having:

[0025] a handle at a proximal end, and

[0026] a finger mechanically coupled to a distal end of the arm via a knuckle joint, the knuckle joint arranged to angle the finger relative to the arm, such that, in use, actuation of the device moves the finger toward the prostate, from an insertion position to an application position; and in the application position, the finger applies pressure to the prostate.Brief Description of the Drawings

[0027] For a better understanding of the invention and to show how the same may be carried into effect, there will now be described by way of example only, specific embodiments, methods and processes according to the present invention with reference to the accompanying drawings in which:

[0028] Figure 1 shows an example device with the finger in the application position. The cover of the device is shown as transparent to enable the joints and bends to be visualised.

[0029] Figure 2 shows a different example device with the finger in the insertion position.

[0030] Figure 3 shows a schematic of the interior of an example device wherein 3A is in the insertion position and 3B is in the application position. The device is shown with a grip handle and a release button.

[0031] Figure 4A shows a mechanical schematic of an example hydraulic knuckle joint mechanism and 4B shows the mechanism inside the device.

[0032] Figure 5A shows a mechanical schematic of an example hydraulic knuckle joint mechanism with a built in safety valve and 5B shows the mechanism inside the device.

[0033] Figure 6 shows an example device in which the joint mechanism is a pawl and ratchet system operated by a grip handle.

[0034] Figure 7 shows an example device in which the joint mechanism is a rack and pinion system operated by a grip handle and gearing is used to translate the gripping action on the handle into pressure applied by the finger.

[0035] Figure 8 shows an example mechanical device in which the joint mechanism is a rack and pinion system operated by a grip mechanism. Gearing is used to translate the gripping action on the handle into pressure applied by the finger.

[0036] Figure 9 shows an example hydraulic device in which the joint mechanism is operated by a grip mechanism. Volume differences in the cylinders is used to translate the gripping action on the handle into pressure applied by the finger.

[0037] Figure 10 shows an electrical device in which the joint mechanism is driven by an electric motor. Gearing is used to adjust pressure applied by the finger.

[0038] Figure 11 shows the amount of pressure applied by a finger during GCPP pressure therapy. Pressure is shown as force applied in Newtons.

[0039] Figure 12 shows an alternative embodiment with a fixed knuckle joint (64).

[0040] Detailed Description

[0041] Figures 1 and 2 show CAD renderings of two variations of the device according to the present invention. In figure 1, the handle 8 is integral with the arm 2, being a portion thereof. In figure 2, the handle 8 is still at the proximal end of the arm 2, but it forms a distinct structure. It will be appreciated that manydifferent variants of handle 8 could be employed without deviating from the scope of the invention. Figures 1 and 2 each feature a finger 6 mechanically coupled to the distal end of the arm 2 via a knuckle joint 4. They both feature a bend 12 in the arm 1, proximal to the knuckle joint 4, it will be appreciated that this bend improves the ergonomics of the device for self use.

[0042] Figure 1 is shown with the knuckle joint actuated, such that the finger is in the application (bent) position whilst figure 2 is shown in the insertion position. The outer covering of the device is shown as transparent in figure 1 to enable better visualisation of an example configuration of bends and joints. More than one bend in the arm 2 can be seen, it should be noted that the bends 12 can be fixed or adjustable, for example via a wrist joint, and, where adjustable, can be mechanically or manually adjustable. In some embodiments the knuckle joint and wrist joint may be controlled by the same mechanism. Figures 1 and 2 each show an operation means 10 in the form of a button.

[0043] Figures 3A and 3B show the inner mechanics of an example device in A the insertion position and B the application position. The handle 10 is shown as a grip mechanism which, when squeezed, causes the knuckle joint 4 to actuate, bending the finger 6 from the insertion position to the application position. Use of a ratchet system may be employed prevent the reversal of the bending on release of the grip and would allow pressure to be applied incrementally. Use of gearing and / or pulleys may be employed to translates the force of the grip handle being squeezed into greater force (pressure) applied to the prostate. A release button 14 is shown at the top of the arm. The release button is intended to straighten the bend in the knuckle joint and return the finger to the insertion position, thereby reducing pressure applied to the prostate. The release could be incremental or one-step release.

[0044] Figures 4A and 5A show mechanical schematics with Figures 4B and 5B showing the mechanical parts in situ in the respective devices. In the specific examples, the knuckle joint mechanism is shown as pneumatic or hydraulic although it will be appreciated that any suitable means of actuating the knuckle joint may be used. In use, the user depresses the operation means 10 which actuates single acting cylinder (sac) 20 (referred to as push cylinder), sac 20 acts on a second sac 22 (referred to as main cylinder) causing tension wire 28 to tighten and wrap around pulleys 30. The tension wire 28 acts as a ligament and causes the knuckle joint 4 to bend, thereby moving the finger 6 toward the application position. When the user presses the release button 14, a 2 / 2 valve 24 releases the tension on the tension wire 28 and the finger 6 returns to the insertion position. The equaliser 26 performs two functions, in the hydraulic device it gives a positive pressure when the push cylinder 20 is pulled up and sucks in fluid and also has a large enough volume to more the main cylinder 22 between minimum and maximum engagement.

[0045] Figure 5A shows the addition of a safety valve 32 which is arranged to release the pressure applied by the finger 6 if a limit is exceeded.

[0046] Figure 6 and figure 7 show variants of a grip handle mechanism and how they actuate the knuckle joint via the knuckle joint mechanism. In figure 6, the operation means 10 is shown as a grip handle mechanism. Squeezing 10 actuates single acting cylinder (sac) 20 (referred to as push cylinder), sac 20 acts on a second sac 22 (referred to as main cylinder) causing tension wire 28 to tighten and wrap around pulleys 30. The tension wire 28 acts as a ligament and causes the knuckle joint 4 to bend, thereby moving the finger 6 toward the application position. Upon squeezing grip handle 10, a pawl and ratchet mechanism prevents tension in the tension means 28 being released and allows the user to gripthe handle again to move the finger 6 more, thereby increasing the bend in knuckle joint 4 and the amount of pressure applied in the application position. Using a linear rack as shown in figure 6 limits the number of times that the grip handle can be depressed, thereby limiting the amount of pressure that can be applied by the finger 6. When the user presses the release button 14, the tension on the tension wire 28 is released and the finger 6 returns to the insertion position.

[0047] Figure 7 builds on figure 6 by employing pulleys 30 and gears 36 to translate the grip pressure into greater pressure applied in the application position.

[0048] Figure 8 shows an example embodiment where the device is driven by a manually powered knuckle joint mechanism when the operation means 10 is pushed (squeezed), this causes the tension wire 28 to be pulled. This actuates a pulley in the knuckle joint 4 causing the finger 6 to rotate at the knuckle joint, i.e. bend into the application position. The knuckle joint mechanism comprises a gear rack 38, a gear 36, and a one-way bearing 40 in communication to allow the operation means 10 to stop in any position -that is, at any stage of being squeezed. The device comprises a release button 14, which functions such that, when pressed, the gear rack 38 is released free from the gear 36 and one way bearing 40, allowing the operation means 10 and finger 6 to return to their respective starting positions. The operation means 10 and finger 6 are configured to spring return via spring 42. In the event that the tension wire 28 should break, the finger 6 returns to the insertion position.

[0049] Figure 9 shows another example embodiment where the device is driven by a hydraulically powered knuckle joint mechanism when the operation means 10 is pushed (squeezed) the push cylinder 20 pushes fluid into the main cylinder 22. Because of differences between the cylinder volumes and configurations, this displacement of fluid leads to a 1:10 increase in force. Movement of the main cylinder 22 pulls the tension wire 28 which actuates a pulley in the knuckle joint 4 causing the finger 6 to rotate at the knuckle joint, i.e. bend into the application position. The operation means 10 is squeezed ten times to bend the finger 6 approximately 45 degrees into the application position. The push cylinder 20 can suck fluid over a check valve 46 from the equaliser 26. The equaliser 26 has enough fluid to move the main cylinder 22 from a minimum to a maximum position. The device comprises a release button 14, this functions such that, when pressed, the finger 6 returns to the insertion position. The device also comprises a safety valve (over-pressure valve) 44 which limits maximum pressure.

[0050] Figure 10 shows another example embodiment where the device is driven by an electrically powered knuckle joint mechanism wherein an open / close button (not shown) is configured to stop and start an electric motor 56. The motor 56 drives a gear box 58 which is connected to a flexible coupling 52. The flexible coupling 52 drives a linear drive 54 that pulls the tension wire 28. The tension wire 28 sits onto a clutch 50. When started, the finger 6 rotates (bends) into the application position and resistance to the bending causes the rotation to stop.

[0051] Figure 12 shows a CAD rendering of an embodiment of the device according to the present invention. The handle 8 is integral with the arm 2, being a portion thereof. It will be appreciated that many different variants of handle 8 could be employed without deviating from the scope of the invention. Figure 12 features a finger 6 coupled to the distal end of the arm 2 via a knuckle joint 64. The device features a bend 12 in the arm 2, proximal to a fixed, rigid knuckle joint 64, it will be appreciated that this bend improves the ergonomics of the device for self use.Figure 12 shows a fixed, rigid knuckle joint, such that the finger is not bendable relative to the arm. It should be noted that the bend or bends 12 can be fixed or adjustable, for example via a wrist joint, and, where adjustable, can be mechanically or manually adjustable. The device of Figure 12 is operable by manual positioning of the finger controlled by movement of the arm.

[0052] In use, the device is in the insertion position. The device finger is inserted into the rectum and sited such in proximity of the prostate. The user then actuates the knuckle joint by the operation means. The knuckle joint mechanism translates the signal from the operation means into actuation of the knuckle joint. The joint bends and the finger is moved toward the prostate, applying pressure thereto. In this application position the pressure may be increased up to a maximum. Pressure may then be released using the release mechanism and the process of bending the finger to apply pressure may be repeated. Once treatment is completed, the device is returned to the insertion position and removed from the rectum.

[0053] In use, the rigid device's finger is inserted into the rectum and sited such in proximity of the prostate. The user then manipulates the device so that the finger is moved toward the prostate, applying pressure thereto. In this application position the pressure may be increased or decreased manually by adjusting the handle. Once treatment is completed, the device is removed from the rectum.

[0054] The rigid device is intended to be used as a wellness device with the aim of alleviating the symptoms of a prostate condition.

[0055] The device may be approximately 300mm long, such as in the range 250 to 350mm. For example, the device may be approximately 260, 270, 280, 290, 300, 310, 320, 330, or 340mm long.

[0056] As employed herein a therapeutic amount of pressure refers to the amount of pressure necessary to provide a therapeutic effect on the prostate. Therapeutic effects may include one or more of the following:

[0057] - Reduction or break down of hard and organised foci of inflammation in the prostate.

[0058] - Remove obstructions in the prostatic glandular ducts.

[0059] - Release strangulated nerves.

[0060] - Allow the smooth flow of the prostatic fluid in glandular tubes.

[0061] - Restore microvascular circulation in the glandular tissue.

[0062] - Remove microbial cores.

[0063] - Restore a correct immune response to the healthy prostate glandular tissue.

[0064] A therapeutic amount of pressure is considered to be greater than the pressure applied during prostate massage or milking. Similarly, therapeutic pressure is considered to be greater than the stimulation caused by the vibration of sex toys.Anatomical terms used throughout are intended to have their normally understood meaning. For example, a knuckle joint bends and straightens a finger.

[0065] As employed herein, the arm is substantially linear and rigid. The arm acts as a housing for the mechanical parts of the device that drive the bending of the joint. In some embodiments the arm may not be straight and may have curvatures which may be functional or decorative. The arm has a proximal end and a distal end. The arm may have a substantially cylindrical profile or may be any suitable profile either circular or otherwise, in cross section. The arm may be ergonomically designed for ease of use. The arm may feature one or more bends at the distal end of the arm, proximal to the knuckle joint. The bend(s) introduce angles to the arm, making it more ergonomic and therefore easier to use for self-use. The bend may occur as a single bend, or multiple smaller bends, or even as a curvature. The aim of the bend is to enable easier positioning of the finger for insertion into the rectum. The bend maybe fixed angle or adjustable angle, where adjustable this may be achieved by means of a wrist joint. The wrist joint may be mechanically driven or manually adjusted. The wrist joint may bend in more than one plane to increase the customisation of the device to the user's preferences. Where motorised, the wrist joint may be driven by the knuckle joint mechanism or by a separate mechanism.

[0066] In some embodiments the device comprises a bend in the arm, proximal to the knuckle joint, the bend may be a fixed angle or an adjustable angle which is adjustable via a wrist joint.

[0067] In some embodiments the wrist joint may be mechanically controlled or manually manipulated by a user.

[0068] In some embodiment the fixed angle or the adjustable angle is up to 90 degrees. For example, approximately 45, 50, 55, 60, 65, 70, 75, 80 or 85 degrees.

[0069] In some embodiments, the bend in the arm may be made of a one or more curves, or a series of bends that create a curve.

[0070] The bend(s) may, advantageously, permit or assist in accurate positioning of the finger close to the prostate.

[0071] Handle as employed herein refers to the section of the device that is intended to be held during use. The handle resides at or close to the proximal end of the arm, at the opposite end to the finger. The handle may be a region of the arm for holding, that is integral with the arm, or may be a separate, distinct region of the arm. The handle may have additional functionality in addition to being the holding site.

[0072] In some embodiments the handle is, or comprises, an operation means.

[0073] In some embodiments the device comprises an operation means.

[0074] In some embodiments the knuckle joint mechanism is operated by an operation means.

[0075] As employed herein the operation means operates the knuckle joint mechanism. That is, activation of the operation means caused the knuckle joint mechanism to drive the knuckle joint, thereby bending the finger. The operation means may be any suitable component, for example, a button, or a gripmechanism. The operation means may be in direct or remote control of the knuckle joint mechanism. The operation means could be a timer configured to apply a series of bends in the knuckle joint.

[0076] In some embodiments the operation means is a grip mechanism which, when squeezed one or more times, actuates, via the knuckle joint mechanism, the knuckle joint to bend the finger into the application position.

[0077] Grip mechanism as employed herein refers to a device which is intended to be squeezed (typically by the user's hand). Generally, a grip mechanism requires the use of more than one finger, and may require the use of the full hand. A grip mechanism may require more force to move than, for example, pressing a button might.

[0078] Finger as employed herein refers to the moveable portion of the device which is mechanically coupled to the distal end of the arm via a knuckle joint. Actuation of the knuckle joint results in the (distal) tip of the finger applying pressure to the prostate. In general, the finger moves from an insertion position which is substantially linear to the part of the arm immediately proximal to the knuckle joint, into an application position in which it is bent up to approximately 45 degrees relative to the insertion position, although greater than 45 degree bends are envisioned too. In some instances, the finger may be of sufficient length that the knuckle joint may be sited at or near the anus, in use, and bending alone brings the tip of the finger into contact with the prostate. In other instances, the distal portion of the arm is also inserted into the rectum, enabling a shorter finger to be employed and the knuckle joint to reside in the rectum during use. This may lead to a more comfortable experience for the user.

[0079] In some embodiments the knuckle joint is rigid or fixed. That is, the knuckle joint does not bend relative to the arm. In these embodiments, the knuckle joint provides an angle in the finger relative to the arm. In some embodiments, this angle is approximately 45 degrees.

[0080] In some embodiments, a greater than 45 degree bend in the application position may be employed to apply more pressure to the prostate.

[0081] Since the prostate is typically situated approximately 5cm inside the rectum, the device must be configured such that the tip of the finger can contact the prostate.

[0082] Thus, the finger may be in the range approximately 30 to 60mm long, such as 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, or 59mm.

[0083] In one embodiment the length of the finger is in the range 40 to 50mm.

[0084] In one embodiment the length of the finger is more than 40mm.

[0085] In one embodiment the length of the finger is less than 50mm.

[0086] In some embodiments the finger is approximately 46mm in length.

[0087] Insertion position as employed herein means the finger is not bent from the knuckle joint.Where part of the arm is inserted into the rectum, the insertion position is required to be substantially linear between the distal part of the arm, the knuckle joint, and the finger. That is, approximately 180 degrees.

[0088] In some embodiments the finger is substantially cylindrical.

[0089] In some embodiments the diameter or width of the finger is in the range approximately 10 to 25mm. Such as 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24mm.

[0090] In one embodiment the diameter or width of the finger is approximately 14mm.

[0091] In one embodiment the width of the finger is more than 10mm.

[0092] In one embodiment the width of the finger is less than 25mm.

[0093] The finger may be of any suitable shape and may be substantially straight, or may be curved or bent. Any curvature is angled toward the prostate, in use. The application surface of the finger, that is, the surface that contacts the prostate in the application position, may be curve, flat, cupped (concave), paddle-shaped by way of example.

[0094] The finger may feature a textured surface.

[0095] Application position as employed herein refers to the position of the finger when it is bent to any extent away from the insertion position. There may be multiple application positions with varying degrees of bend, that is, different extents to which the knuckle joint is actuated. The application position moves the tip of the finger closer to the prostate and applies increasing pressure to the prostate. In some cases, the degree of bending is up to approximately 45 degrees relative to the insertion position.

[0096] In some embodiments, the degree of bending is up to 90 degrees relative to the insertion position, for example, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 15 or 10 degrees.

[0097] In one embodiment the application position creates an angle between the distal end of the arm and the finger of up to 135 degrees.

[0098] In one embodiment the application position creates an angle between the distal end of the arm and the finger of up to 90 degrees, for example, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165 or 170 degrees.

[0099] The insertion position may be approximately 180 degrees, that is, the angle created by the finger, knuckle joint and distal position of the arm is 180 degrees. The application position may bend up to 45 degrees away from the insertion position. Thus, in this example, the angle between the finger and the arm, in the application position, is approximately 135 degrees.

[0100] Knuckle joint as employed herein refers to the joint connecting the finger to the arm. The joint is intended to bend toward the prostate and to straighten to the insertion position but not to bend away from the application position, that is, not significantly further than 180 degrees. The bend in the knuckle joint may be in one plane or may vary away from the plane without deviating from the scope of theinvention. This movement would enable different areas of the prostate to be contacted and pressure applied.

[0101] In some embodiments the knuckle joint does not move. That it, is it rigid or fixed. In these embodiments, the device may lack a knuckle joint mechanism.

[0102] Knuckle joint mechanism as employed herein refers to the mechanical parts that drive movement of the knuckle joint. It is not possible to simply bend the finger by manipulating it into the application position before insertion without causing a great deal of discomfort. Therefore, it is necessary to be able to actuate the joint mechanically. This movement can be powered using any suitable means, including but not limited to, electrical, hydraulic, pneumatics, mechanical (manually controlled by translation of feree input from a user).

[0103] In one embodiment the knuckle joint mechanism is manually powered. That is, there is no electrical, hydraulic, pneumatic or other power source.

[0104] In one embodiment the knuckle joint mechanism is manually operated.

[0105] In one embodiment the knuckle joint mechanism is hydraulically powered.

[0106] In one embodiment the knuckle joint mechanism is hydraulically operated.

[0107] In one embodiment the knuckle joint mechanism is electrically powered.

[0108] In one embodiment the knuckle joint mechanism is electrically operated.

[0109] In one embodiment the knuckle joint mechanism is powered by a battery.

[0110] In one embodiment the knuckle joint mechanism is ratcheted.

[0111] Using a ratcheted knuckle joint mechanism enables the finger to move incrementally and hold in subapplication positions. That is, positions that are not applying the full pressure available. This may be advantageous where the user is new to the treatment or has underlying pain prior to treatment and cannot tolerate the full pressure. A ratchet system also allows for manual actuation of the knuckle joint mechanism, for example, via a grip handle mechanism which must be squeezed repeatedly to achieve full bending of the finger into the application position.

[0112] In some embodiments a wire is used to create tension on the knuckle joint, thereby bending the joint. The wire may be steel or kevlar, for example. The functionality of the wire is analogous to a ligament wherein the more tension on the wire, the greater the bend of the joint. The wire need not be metallic. In an example embodiment where the device is driven by a manually powered knuckle joint mechanism when the operation means is pushed, this causes the tension wire to be pulled. This actuates a pulley in the knuckle joint causing the finger to rotate at the knuckle joint, i.e. bend into the application position. In some embodiments the knuckle joint mechanism may comprise a gear rack, a gear and a one-way bearing in communication to allow the operation means to stop in any position - that is, at any stage of being squeezed. Where the device comprises a release button, this may function such that, when pressed, the gear rack is released free from the gear and one way bearing, allowing the operationmeans and finger to return to their respective starting positions. The operation means and finger may be configured to spring return. In the event that the tension wire should break, the finger thus returns to the insertion position.

[0113] In another example embodiment where the device is driven by a hydraulically powered knuckle joint mechanism when the operation means is pushed the push cylinder pushes fluid into the main cylinder. Because of differences between the cylinder volumes and configurations, this displacement of fluid leads to a 1:10 increase in force. Movement of the main cylinder pulls the tension wire which actuates a pulley in the knuckle joint causing the finger to rotate at the knuckle joint, i.e. bend into the application position. In some embodiments, the operation means is squeezed ten times to bend the finger approximately 45 degrees into the application position. The push cylinder can suck fluid over a check valve from the equaliser. The equaliser has enough fluid to move the main cylinder from a minimum to a maximum position. Where the device comprises a release button, this may function such that, when pressed, the finger returns to the insertion position. In some embodiments the device may also comprise a safety valve (over-pressure valve) which limits maximum pressure.

[0114] In another example embodiment where the device is driven by an electrically powered knuckle joint mechanism an open / close button is configured to stop and start an electric motor. The motor drives a gear box which is connected to a flexible coupling. The flexible coupling drives a linear drive that pulls the tension wire. The tension wire sits onto a clutch. When started, the finger rotates (bends) into the application position and resistance to the bending (provided by the prostate) causes the rotation to stop.

[0115] Since full pressure may not be desirable and at the end of treatment the device must return to the insertion position before removing the device from the rectum (to prevent injury and / or discomfort) it is necessary to provide a release mechanism that performs the action of releasing the bend in the knuckle joint. This may take any suitable form and may include an over-pressure release mechanism to prevent accidental or intentional over bending of the finger, hence too much pressure being applied to the prostate.

[0116] In one embodiment the knuckle joint mechanism has a release mechanism that straightens the finger into the insertion position.

[0117] In one embodiment the device has a release button that activates the release mechanism.

[0118] As employed herein "knuckle joint is operable to bend the finger relative to the arm" describes the bending motion relative to the distal end of the arm. That is, the part of the arm closest to the knuckle joint. As described above, the bend ranges from linear, approximately 180 degrees, in the insertion position, to for example, an approx. 45 degree bend from linear in the application position. That is, there is an approx. 135 degree angle formed by the finger and the arm. The knuckle joint creates the bend.

[0119] As employed herein "actuation of the knuckle joint bends the finger toward the prostate" refers to the movement required to bend the knuckle joint and bend the finger into the application position. In general, the finger does not need to bend away from the prostate beyond the insertion position. The actuation may occur by any suitable means but is driven by the knuckle joint mechanism.In one embodiment the finger applies in the range 0 to 200N of force. Such as approximately 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190N.

[0120] In one embodiment, the torque is approximately 9.2N-mm (0.0092N-m) at the tip of the finger. For example, in the range 8 and 10N-mm, such as 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.3, 9.4, 9.5, 9.69.7, 9.8, or 9.9N-mm.

[0121] In one embodiment the finger applies up to 200N amount of force to the prostate.

[0122] In one embodiment the finger applies substantially no force in the insertion position.

[0123] In one embodiment the finger applies up to 200N of force in the application position.

[0124] In one embodiment the knuckle joint mechanism generates up to 200N of force in the application position.

[0125] Pressure (Pa) is the amount of force (N) acting on a given area (A) in m2(P = F / A). Thus, the amount of pressure applied depends on the area in addition to the force. Given the prostate can be enlarged and the dimensions of the finger may be varied pressure may be difficult to precisely measure. As such, references to pressure herein may be interpreted as the amount of force applied to the prostate. The force being generated by the knuckle joint mechanism.

[0126] Therapeutic amount of pressure as employed herein means that up to 200N of force is applied to the prostate using the finger of the device. For example, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190N of force is applied to the prostate.

[0127] In one embodiment the surface area of the finger is in the range approximately 140 to 1000mm2. Such as approximately 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, or 950mm2.

[0128] In one embodiment the surface area of the finger is approximately 644mm2(based on a length of 46mm and a width of 14mm).

[0129] By surface area, it is intended to refer to the surface capable of contacting the prostate. That is, the side of the finger facing the prostate in use. This surface could be viewed as the application surface. It will be appreciated, in some circumstances, that not all of the application surface contacts the prostate in the application position.

[0130] Where the application surface of the finger is approximately 644mm2, the pressure applied by the finger at 200N would be 200 / 0.000644 = 310,559Pa (approx. 311kPa).

[0131] Although the amount of pressure applied to the prostate could be approximately 311kPa, in practice, this amount of pressure is likely to only be applied momentarily and only to prostates with the highest level of sclerosis / fibrosis. In general, the amount of pressure applied is likely to be in the range approximately 70 to 200kPa.Thus, a therapeutic amount of pressure is considered to be over 50kPa and up to 350kPa. Such as approximately 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, or 340kPa.In one embodiment a therapeutic amount of pressure is at least 50kPa.

[0132] In one embodiment a therapeutic amount of pressure is at least 70kPa.

[0133] In one embodiment a therapeutic amount of pressure is at most 350kPa.

[0134] In one embodiment a therapeutic amount of pressure is at most 300kPa.

[0135] In one embodiment a therapeutic amount of pressure is in the range approximately 70 to 300kPa. The device may also comprise one or more sensors which are configured to sense and / or provide feedback on a number of parameters. For example, sensors may determine how much pressure is being applied to the prostate, or how much resistance to the pressure is provided by the prostate. This pressure and resistance data can be used to inform the treatment programme. Other sensors may detect positioning on the prostate, or detect temperature, or oxygenation levels, for example. Typically, the sensors are located in the finger, on the surface that contacts the prostate although this is not necessarily the case.

[0136] In one embodiment the device further comprises at least one of the one or more sensors is a finger sensor located in the finger, the finger sensor(s) being configured to detect one or more parameters selected from the list:

[0137] amount of pressure applied,

[0138] resistance, for example from prostate stiffness,

[0139] positioning on prostate,

[0140] temperature,

[0141] oxygenation.

[0142] In some embodiments, the device may feature multiple fingers each of which is independently controllable. Such a device would be capable of palpating the prostate and / or applying pressure to different parts of the prostate. The fingers may be contained within a single finger cover such that, from the outside, there is only one part to insert. That is, the fingers appear to be a single finger, but with multiple bones - analogous to fingers in a mitten.

[0143] In some embodiments the finger may feature a curvature such that it curves around the prostate in the application position.

[0144] The device may be manufactured from any rigid material such as plastic or metal (such as stainless steel or aluminium) or a combination thereof. The device may also have a smooth covering, such as a medical grade silicone covering, to help with use and hygiene. Where a hydraulic knuckle joint mechanism is used, the hydraulic fluid may be distilled water.

[0145] As employed herein a saddle joint is a joint that can move side to side in addition to moving between a bent (e.g. application) and a straight (e.g. insertion) position. Anatomically, saddle joints are formed when two curved bones meet. Saddle joints can move in any direction, but cannot usually twist or rotate about an axis. And example saddle joint is the joint where your thumb joins your hand.

[0146] The device may further comprise one or more of the following: ultrasonic, heating, cooling, or vibration components. Wherein the finger may apply ultrasound, heat, cold, or vibration to the prostate.In the context of this specification "comprising" is to be interpreted as "including".

[0147] Aspects of the invention comprising certain elements are also intended to extend to alternative embodiments "consisting" or "consisting essentially" of the relevant elements.

[0148] Where technically appropriate, embodiments of the invention may be combined.

[0149] Embodiments are described herein as comprising certain features / elements. The disclosure also extends to separate embodiments consisting or consisting essentially of said features / elements.

[0150] Approximately as employed herein is intended to mean ±10%.

[0151] Technical references such as patents and applications are incorporated herein by reference.

[0152] Any embodiments specifically and explicitly recited herein may form the basis of a disclaimer either alone or in combination with one or more further embodiments.

[0153] Examples

[0154] In order to determine the pressure applied to a prostate during GCPP, a sensorised haptic glove was developed and worn by an expert in GCPP during a protocol designed to replicate digital rectal examination (DRE). The protocol employed prostate phantoms (analogues) with different stiffness profiles. Examinations were carried out blind (with no view of the prostate phantom) to replicate the situation in the clinic, where the clinician cannot directly view the prostate.

[0155] The expert in GCPP carried out the protocol as normal, and measurements were taken to determine the strength of digital application to the prostate and the movement of the finger during treatment. That is, the pressure or force applied to the prostate models (phantoms) and the positioning of the finger were captured. This data was processed to remove noise, and the data used to determine the required dimensions and force required by the present device.

Claims

Claims1. A mechanical device for administering a therapeutic amount of pressure to a prostate, the device comprising:an arm having a handle at a proximal end, anda finger mechanically coupled to a distal end of the arm via a knuckle joint, the knuckle joint being driven by a knuckle joint mechanism,wherein the knuckle joint is operable to bend the finger relative to the arm, such that, in use, actuation of the knuckle joint bends the finger toward the prostate, from an insertion position to an application position; andin the application position, the finger applies a therapeutic amount of pressure to the prostate.

2. The device according to claim 1 further comprising a bend in the arm, proximal to the knuckle joint, the bend may be a fixed angle or an adjustable angle which is adjustable via a wrist joint.

3. The device according to claim 2 wherein the wrist joint may be mechanically controlled or manually manipulated by a user.

4. The device according to any one of claims 2 or 3 wherein the fixed angle or the adjustable angle is up to approximately 90 degrees.

5. The device according to any preceding claim wherein the knuckle joint mechanism is manually operated.

6. The device according to any preceding claim wherein the knuckle joint mechanism is hydraulic.

7. The device according to any preceding claim wherein the knuckle joint mechanism is electrical.

8. The device according to claim 7 wherein the knuckle joint mechanism is powered by a battery.

9. The device according to any preceding claim wherein the knuckle joint mechanism is operated by an operation means.

10. The device according to claim 9 wherein the operation means is a grip mechanism which, when squeezed one or more times, actuates, via the knuckle joint mechanism, the knuckle joint to bend the finger into the application position.

11. The device according to any one of claims 5, 9, or 10 wherein the knuckle joint mechanism is a rack and pinion.

12. The device according to any preceding claim wherein the knuckle joint mechanism has a release mechanism that straightens the finger into the insertion position.

13. The device according to any preceding claim further comprising one or more sensors.

14. The device according to claim 13 wherein at least one of the one or more sensors is a finger sensor located in the finger, the finger sensor(s) being configured to detect one or more parameters selected from the list:amount of pressure applied,resistance,positioning on prostate,temperature, andoxygenation level.

15. The device according to any preceding claim wherein the application position creates an angle between the arm and the finger of up to 135 degrees.

16. The device according to any preceding claim wherein the knuckle joint is a saddle joint.

17. The device according to any preceding claim wherein the finger is curved or capable of curving.

18. The device according to any preceding claim wherein the finger is approximately 46mm long.

19. The device according to any preceding claim further comprising an ultrasound transmitting component located in the finger.

20. A method of treating a prostate-condition selected from: prostatitis, benign prostate hyperplasia, or chronic pelvic pain syndrome (CPPS) with the device according to any preceding claim, comprising the steps:(i) with the finger in the insertion position, insert finger into the rectum, position close to the prostate,(ii) actuate the knuckle joint to bend the finger into the application position such that it applies pressure to the prostate,(iii) release the pressure, and(iv) optionally repeat steps (i)-(iii).

21. A method of diagnosing prostatitis, benign prostate hyperplasia, or chronic pelvic pain syndrome (CPPS) using the device according to any one of claims 1 to 19.

22. Use of the device according to any one of claims 1 to 19 in the treatment of prostatitis, benign prostate hyperplasia, or CPPS.

23. A mechanical device for administering pressure to a prostate, the device comprising an arm having:- a handle at a proximal end, and- a finger mechanically coupled to a distal end of the arm via a knuckle joint, the knuckle joint arranged to angle the finger relative to the arm,such that, in use, actuation of the device moves the finger toward the prostate, from an insertion position to an application position; and in the application position, the finger applies pressure to the prostate.

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