Patent Description:
The present invention also relates generally to a transverse carpal ligament cutting device.

Carpal tunnel syndrome affects approximately <NUM>% of the general population and up to <NUM>% of manual labor workers. Several varying surgical procedures are performed annually to treat patients with carpal tunnel syndrome. One of these surgical procedures is known as a carpal tunnel release procedure ("CTR procedure"). A primary goal of the CTR procedure is to cut a transverse carpal ligament in order to reduce median nerve compression and carpal tunnel pressures in the carpal tunnel region.

CTR procedures can be performed by accessing the carpal tunnel primarily from the outside or accessing the carpal tunnel primarily from the inside. In the former, a palmar incision of various sizes is used to directly visualize and transect the transverse carpal ligament. In the latter, the transverse carpal ligament is visualized from within the carpal tunnel using an endoscope advanced through a small palmar and/or distal wrist incision - endoscopic carpal tunnel release (ECTR).

One concern with CTR procedures is that it is hard to visualize the transverse carpal ligament and at-risk structures nearby (e.g., a median nerve and an ulnar artery). It is also hard to visualize individual anatomical variations in the carpal tunnel region. As a result, some CTR procedures can cause incomplete release of the transverse carpal ligament and others can cause injuries to the nearby at-risk structures.

In recent years, operators have used ultrasound guidance with CTR procedures to better visualize the carpal tunnel region during the procedure. However, even with the improved visualization of ultrasound, there are still concerns even with these procedures. One concern is that a sharp cutting instrument may be passed into the carpal tunnel without the ability to precisely control deployment of a sharp cutting instrument. Thus, the sharp cutting instrument presents a risk to both the patient and the operator. It would be desirable to provide an improved device that includes a sharp cutting instrument that is not exposed until the cutting of the transverse carpal ligament occurs.

Also, in several operators use ultrasound guidance to place a sharp cutting instrument in position to cut the transverse carpal ligament but do not utilize ultrasound visualization during the actual cutting. In some cases, this is because the sharp cutting instruments require the use of two hands to perform the cutting. Thus, when operators perform the cutting, they are not able to continue holding the ultrasound probe during cutting. It would be desirable to provide an improved device that allows for an operator to continue using ultrasound guidance during cutting. It would also be desirable to provide a device that allows for an operator to use one hand while cutting, so that the opposite hand can hold an ultrasound probe or otherwise engage in providing ultrasound guidance.

Further, there is typically a very narrow space between the median nerve and the ulnar artery in the carpal tunnel. This narrow space is a "safe zone" in which the transverse carpal tunnel ligament can be cut without risk to the median nerve or ulnar artery. This space is variable from patient to patient and can be less than <NUM> millimeters in some patients. Consequently, placing a sharp cutting instrument in this region can expose a patient to risks of injury. It would also be desirable to provide a device that can expand the "safe zone" in a patient to reduce risks of injury.

<CIT> teaches inter alia a cutting device for incising the myocardium through scissors jack cutting means.

<CIT> teaches a cutting device for carpal ligaments with a blade that may selectively protrude out of a lateral shaft opening.

<CIT>, <CIT> and <CIT> are all directed towards medical cutting devices wherein a cutting member is actuated through inflation of a balloon coupled thereto.

The invention is directed to a soft tissue cutting device as defined by appended independent claim <NUM>.

Some embodiments provide a soft tissue device having (a) a shaft having a top surface, two side surfaces and a bottom surface, wherein the shaft extends along a longitudinal axis, (b) a shaft opening that extends for a distance along the longitudinal axis, (c) a blade that extends through and withdraws from the shaft opening, and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft.

Other embodiments provide a transverse carpal ligament cutting device having (a) a shaft having a top surface, two side surfaces and a bottom surface, (b) a shaft opening that extends for a distance along the top surface, (c) a blade having a top cutting edge, and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft, wherein the top cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the top cutting edge extends upwardly through the shaft opening and the one or more balloons are inflated when the device is in an active position.

Other embodiments provide a transverse carpal ligament cutting device having (a) a shaft having a top surface, two side surfaces and a bottom surface, (b) a shaft opening that extends for a distance along the top wall and two side surfaces, (c) a blade having a distal cutting edge, and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft, wherein the distal cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the distal cutting edge extends distally through the shaft opening and the one or more balloons are inflated when the device is in an active position.

Other embodiments provide a transverse carpal ligament cutting device having (a) a shaft having a top surface, two side surfaces and a bottom surface, (b) a shaft opening that extends for a distance along the top wall, (c) a blade having a blade working end, wherein the blade working end includes a cutting edge that faces the proximal end of the device, and (d) a blade guideway within the shaft, wherein the blade working end moves along the blade guideway.

Other embodiments provide a soft tissue cutting device having (a) a shaft having a plurality of surfaces, (b) a shaft opening that extends for a distance along one of the plurality of surfaces, (c) a blade that extends through and withdraws from the shaft opening, (d) an inflation device, a conduit and a balloon, wherein the balloon is coupled to the conduit and the conduit is couple to the inflation device and wherein the balloon expands radially outwardly from the shaft.

The following drawings are illustrative of particular embodiments of the invention and therefore do not limit the scope of the invention. The drawings are not necessarily to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments of the invention will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.

Embodiments of the invention provide a soft tissue cutting device. The device includes a proximal end and a distal end. The proximal end is configured to enable an operator to control various functions on the distal end. The distal end is configured to perform various functions, including cutting soft tissue in a body. The soft tissue cutting device can be used to cut any desired soft tissue in the body. In certain embodiments, the soft tissue cutting device is a transverse carpal ligament cutting device that cuts a transverse carpal ligament in a carpal tunnel region.

The device includes a proximal end. The proximal end includes one or more controls that control various functions on the distal end. For example, in some embodiments, the controls activate movement of a blade. In other embodiments, the controls activate inflating and deflating of balloons. In yet other embodiments, the controls activate suction through a passage.

In some embodiments, the proximal end includes a single-hand handpiece. The single-hand handpiece has a configuration that allows an operator to operate the device using a single hand only. In some embodiments, the single-hand handpiece is configured as a gun-like handpiece. In some cases, the single-hand handpiece is a gun-like handpiece that includes the one or more controls in a trigger area such that the operator can grip the handpiece while operating the one or more controls with fingers. In other embodiments, the single-hand handpiece is configured as a handle. In some cases, the single-hand handpiece is a handle that includes one or more controls in a thumb area such that the operator can use a thumb to operate one or more controls. In yet other embodiments, the single-hand handle also includes one or more clamp-like controls in an area such that the operator can use a hand to clamp the controls. In some embodiments, the single-hand handpiece is a handle that includes one or more controls on an inferior position of the handle such that the operator can use a finger to operate one or more controls. However, skilled artisans will understand that the single-hand handpiece is merely one embodiment of the present invention and is not required. Alternately, two hands or even two operators can operate the present device.

The handpiece is coupled to a shaft that extends distally towards a distal end. The handpiece can be coupled to the shaft using a variety of different configurations. In some cases, the handpiece and shaft have a permanent junction. For example, the handpiece and shaft can have a set angular junction or a set straight junction. In other cases, the handpiece and shaft have an adjustable junction that can be adjusted to accommodate operator preference. In other cases, the handpiece and shaft have a rotatable junction that can be rotated to accommodate operator preference. For example, the handpiece and shaft can have a junction that is adjustable in length or angulation or rotation. In yet other cases, the handpiece and the shaft can have a removable junction so that the handpiece and the shaft are removable from one another.

The shaft has any desired cross-section shape. In some cases, the shaft has a circular cross-section shape. In other cases, the shaft has a non-circular cross section shape. For example, in some cases, the shaft has a squared cross section shape, rectangular cross section shape or squared with round edges cross section shape.

As the shaft extends from the proximal end towards the distal end, it can maintain the same cross-section shape or it can assume a different cross-section shape. For example, in some cases, as the shaft extends from the proximal end to the distal end, it maintains a circular cross-section. In other cases, as the shaft extends from the proximal end to the distal end, it changes from a circular cross-section to a non-circular cross section. In yet other cases, as the shaft extends from the proximal end to the distal end, it maintains a non-circular cross section. In further cases, as the shaft extends from the proximal end to the distal end, it changes from a non-circular cross-section to a circular cross-section.

The shaft can also be provided as a single piece or as a plurality of different pieces. In some cases, the shaft extends from the proximal end to the distal end as a single piece. In other cases, the shaft extends from the proximal end to the distal end as a plurality of piece. The shaft is also formed of any desired medically acceptable material.

The shaft also has any desired size that is suitable for the medical procedure being performed. As the shaft extends from the proximal end to the distal end, it can maintain the same diameter or it can assume a different diameter. In some cases, as the shaft extends from the proximal end to the distal end, it increases in diameter. In other cases, as the shaft extends from the proximal end to the distal end, it increases in diameter.

The device also includes a distal end. The distal end is the working end that inserts into the body region of a patient. The distal end includes the shaft, a tip, a shaft opening, a blade, and one or more radially expanding balloons. In some cases, the distal end also includes one or more suction openings.

The shaft at the distal end has a size and cross-section shape that is suitable for being inserted into the body region of interest. The shaft extends longitudinally along a longitudinal axis. The shaft also has a top surface, side surfaces and a bottom surface. Each of the top surface, side surfaces, and bottom surface can be made up of a single wall or a plurality of walls. Additionally, each wall can be a straight wall or a curved wall. In some cases, the shaft is circular, such that the top quarter of the circle forms the top surface, the bottom quarter of the circle forms the bottom surface, and the remaining quarters form the side surfaces. In other cases, the shaft is non-circular. The shaft also has a surface that is destined to be positioned adjacent (or even in direct contact with) the soft tissue being cut. In some cases, the top surface is the surface destined to be positioned adjacent the soft tissue.

The distal end also includes a tip. The tip is the distal-most end of the device and is positioned distally to the shaft. In some cases, the tip is an extension of the shaft. In other cases, the tip is a separate piece that is positioned on the distal end of the shaft. The tip can have any size or shape that guides the distal end to the body region. In some embodiments, the tip has a rounded configuration, ovoid configuration, pointed configuration or conical configuration. In some embodiments, the tip is an echogenic tip and includes an ultrasound probe, camera or one or more optical fiber elements to transmit light to or from the distal region of the tip to the proximal portion of the device and is sized and shaped to house an ultrasound probe, camera or one or more optical fiber elements.

The shaft also includes a shaft opening. The shaft opening extends along a longitudinal axis for a distance longitudinally along the shaft. The shaft opening also extends along the shaft surface that is destined to be positioned adjacent to or in direct contact with the soft tissue being cut. In some embodiments, the shaft opening extends longitudinally along the top surface and two side surfaces, so that the shaft opening is open superiorly, medially and laterally. This results in an "open" shaft opening. In other embodiments, the shaft opening extends longitudinally only along the top surface, so that the shaft opening is only open superiorly. This results in a "closed" shaft opening.

The shaft also houses a blade. The blade includes a working end that has a cutting edge that is configured to cut the soft tissue. The cutting edge can have any desired configuration that cuts soft tissue. In some cases, the cutting edge has a sharp straight edge. In other cases, the cutting edge has a sharp curved edge. In yet other cases, the cutting edge has an angulated, toothed or sawed edge. The cutting edge extends through the shaft opening when the device is in an active position and is protected within the shaft when the device is in an inactive position.

The cutting edge can also be positioned on any surface of the blade. In some cases, the blade working end is linear and the cutting edge is provided on a distal edge. In other cases, the blade working end is linear and the cutting edge is provided on a top edge. In other cases, the blade working end is configured as a hook and the cutting edge is provided on an interior surface of the hook. In other cases, the blade has two cutting surfaces allowing the blade to cut when pushed or pulled through soft tissue.

The blade is also movable with respect to the shaft using any number of different mechanisms. In accordance with the present invention, the blade is movable by inflating and deflating a blade balloon elevator. The blade balloon elevator raises the blade out of the shaft and lowers the blade back into the shaft. In other cases, the blade is movable by moving the blade along a blade guideway. The blade guideway can also have a number of different configurations. For example, in some cases, the blade guideway is a substantially flat guide rail. In other cases, the blade guideway includes a one or more ramps or inclines.

In other cases, blade guideway has an adjustable height, allowing an operator to increase or decrease cutting depths. Different patients have different transverse carpal tunnel thicknesses and an adjustable blade guideway allows an operator to adjust for these different thicknesses. The blade guideway height can be adjusted using any desired adjustment mechanism. In certain cases, the blade guideway height is adjusted by changing the angle of the ramps or inclines. In other cases, the blade guideway height is adjusted using a balloon elevator.

The shaft also includes one or more balloons that expand radially outwardly from the shaft. The balloons serve a number of different purposes. First, the balloons help to anchor the device within the body region to provide stability during cutting of the soft tissue. Also, the balloons help to push nearby at-risk structures away from the device during cutting. This helps to ensure that only the desired soft tissue is cut and that nearby at-risk structures are not cut.

The shaft can have any desired number of radially-expanding balloons. In some cases, the shaft includes a lateral balloon that expands radially outwardly from one of the two side walls. In other cases, the shaft includes a dorsal balloon that expands radially outwardly from the bottom wall. Skilled artisans will understand that the shaft can have any desired number of lateral and/or dorsal balloons.

In some embodiments, the distal tip includes one or more balloons that expand radially outward from the distal tip. Like the shaft, the distal tip can include any desired number of radially-expanding balloons. In some cases, the distal tip includes a dorsal balloon that expands radially outward form a bottom surface of the tip. These balloons serve the same purposes as the balloons that expand from the shaft.

When inflated, the balloons can have any desired configuration. In some cases, the balloons have a spherical configuration. In other cases, the balloons have an oval configuration. In yet other cases, the balloons have a bilobular configuration.

The balloons can also be inflated and deflated using a number of different techniques. Generally, an inflation device supplies inflation material to inflate the balloons and removes inflation material to deflate the balloons. The inflation material can be a gas (e.g., air) or a liquid or fluid (e.g., water or saline). The balloons can also inflate to a desired size selected to accommodate the patient body area of interest. For example, in some cases, the balloons can be provided with a specific size such that when they are fully inflated, they have a specific inflated size. In other cases, the balloons can have a standard size but can be partially inflated or fully inflated to have a variety of different inflated sizes. In some cases, the balloon inflation can be graded to allow the operator to choose a particular balloon diameter. In certain cases, the balloon inflation can be pressure dependent, such that the balloon manually or automatically inflates until a specific pressure is exerted on the balloon surface.

The inflation device supplies inflation material to the balloons using any desired arrangement. In some cases, the shaft includes one or more conduits operably coupled to both the balloons and the inflation device to deliver and remove gas/fluid to and from the balloons. In some cases, a single conduit is used to deliver and remove gas/fluid to and from the balloons. In other cases, a plurality of conduits can be used. In one example, a first conduit can deliver and remove gas/fluid to and from a first balloon while a second conduit can deliver and remove gas/fluid to and from a second balloon. In another example, a first conduit can deliver gas/fluid to all of the balloons while a second conduit can remove gas/fluid from all of the balloons. Skilled artisans will understand that any arrangement of conduits can be used.

In some embodiments, the distal end also includes a plurality of suction openings. In some cases, the suction openings can be provided along the shaft surface that is destined to be positioned adjacent to or in direct contact with the soft tissue being cut. In many cases, the suction openings are provided along a top surface of the shaft. The suction openings can have any desired configuration. In some cases, the suction openings are circular holes. In other cases, the suction openings are slots. In yet other cases, the suction openings are provided as a single elongated slot that extends along a shaft longitudinal axis.

Suction is applied to the suction openings to suck air through the suction openings. This causes soft tissue near the suction openings to move closer to the surface. Suction can be applied to the suction openings using any desired mechanism. In some cases, the shaft includes one or more conduits operably coupled to the suction openings to apply suction to the suction openings. In some cases, a single conduit is used to apply suction to the suction openings. In other cases, a plurality of conduits can be used. For example, a first conduit can apply suction to some of the suction openings and a second conduit can apply suction to other of the suction openings. Skilled artisans will understand that any arrangement of conduits can be used.

In some embodiments, the distal tip includes a portion that expands and contracts so the tip can be inserted into the body with a smaller cross-section and then expanded once in the body to a larger cross-section. In some cases, the portion that expands and contracts is an outer shell provided on the distal tip. For example, the outer shell can be provided along a portion of the shaft (or the entire shaft) to expand radially outward when positioned in the body to create a greater distance between the central/ventral portion of the device when the knife is exposed during activation. Such an outer shell provides even further protection to the body structures near the tissue being cut. The outer shell can expand and contract using any known mechanism. In some cases, the outer shell includes a firm material. In other cases, the outer shell includes a malleable material. Mechanisms that expand/contract an outer shell include but are not limited to a coil, wedge and sleeve mechanism, a sliding wedge bolt mechanism, an expansion-shell bolt mechanism, slot and wedge bolt mechanism, and a balloon expander/contracter mechanism. Skilled artisans will also understand that any number of outer shells can be provided on the distal tip.

Certain exemplary embodiments of a transverse carpal ligament cutting device <NUM> will now be described with reference to the Figures. <NUM>-<NUM> illustrate a transverse carpal ligament cutting device <NUM> according to an embodiment. The device <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> can have any configuration to enable an operator to control various functions on the distal end <NUM>. In some cases, the proximal end <NUM> includes a single-hand handpiece according to any desired configuration. The distal end <NUM> is configured to perform various functions, including cutting a transverse carpal ligament in a carpal tunnel region.

<FIG> illustrates a side view of a proximal end <NUM> according to an embodiment. As shown in <FIG>, the proximal end <NUM> includes a single-hand handpiece <NUM>. The single-hand handpiece <NUM> has a configuration that allows an operator to operate the device <NUM> using a single hand only. The handpiece <NUM> can have any desired handpiece configuration. In <FIG>, the handpiece is configured as a gun-like handpiece. However, skilled artisans will understand that the handpiece can instead have any other embodiment described herein for a handpiece. For example, the handpiece can instead be configured as a handle <NUM> as shown in any of <FIG>, <FIG> and <FIG>.

In <FIG>, the handpiece <NUM> is configured as a gun-like handpiece that includes the one or more controls <NUM> in a trigger area such that the operator can grip the handpiece <NUM> while operating the one or more controls with fingers. For example, in some embodiments, the controls <NUM> activate movement of a blade. In other embodiments, the controls <NUM> activate inflating and deflating of balloons. In yet other embodiments, the controls <NUM> activate suction through a passage.

The handpiece <NUM> is coupled to a shaft <NUM> that extends distally towards a distal end. The handpiece <NUM> can be coupled to the shaft <NUM> using a variety of different configurations. In some cases, the handpiece <NUM> and shaft <NUM> have a permanent junction. For example, the handpiece <NUM> and shaft <NUM> can have a set angular junction or a set straight junction. In other cases, the handpiece <NUM> and shaft <NUM> have an adjustable junction that can be adjusted to accommodate operator preference. For example, the handpiece <NUM> and shaft <NUM> can have a junction that is adjustable in length or angulation. In yet other cases, the handpiece <NUM> and the shaft <NUM> can have a removable junction so that the handpiece <NUM> and the shaft <NUM> are removable from one another.

The shaft <NUM> has any desired cross-section shape. As the shaft <NUM> extends from the proximal end <NUM> towards the distal end <NUM>, it can maintain the same cross-section shape or it can assume a different cross-section shape. In some cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it maintains a circular cross-section. In other cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it changes from a circular cross-section to a non-circular cross section. In yet other cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it maintains a non-circular cross section. In further cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it changes from a non-circular cross-section to a circular cross-section.

The shaft <NUM> can also be provided as a single piece or as a plurality of different pieces. In some cases, the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM> has a single piece. In other cases, the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM> as a plurality of pieces. The shaft <NUM> is also formed of any desired medically acceptable material.

The shaft <NUM> also has any desired size that is suitable for performing a CTR procedure. As the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it can maintain the same diameter or it can assume a different diameter. In some cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it increases in diameter. In other cases, as the shaft <NUM> extends from the proximal end <NUM> to the distal end <NUM>, it increases in diameter.

The device <NUM> includes a distal end <NUM> that is the working end that inserts into the carpal tunnel region. <FIG> illustrate views of a distal end <NUM> according to one embodiment. The distal end <NUM> includes a shaft <NUM>, tip <NUM>, a shaft opening <NUM>, a blade <NUM>, a blade guideway <NUM>, a blade stop <NUM>, a first lateral balloon 34a and a second lateral balloon 36b. Each of these components work together to safely cut a transverse carpal ligament in a carpal tunnel region.

The distal end <NUM> includes a shaft <NUM> that has a size and cross-section shape that is suitable for being inserted into the carpal tunnel region. The shaft <NUM> extends longitudinally along a longitudinal axis "x. " The shaft <NUM> has a top surface <NUM>, side surfaces <NUM>, <NUM>, and a bottom surface <NUM>. In this first embodiment, the shaft <NUM> has a non-circular cross-section such that top surface <NUM> includes a single top wall, the side surfaces <NUM>, <NUM> include two side walls, and the bottom surface <NUM> includes three side walls. Of course, skilled artisans will understand that the shaft <NUM> can include any other desired cross-section and that each shaft surface can include any desired number of side walls.

The distal end <NUM> includes a tip <NUM>. The tip <NUM> is the distal-most end of the device <NUM> and is positioned distally to the shaft <NUM>. In some cases, the tip <NUM> is an extension of the shaft <NUM>. In other cases, the tip <NUM> is a separate piece that is positioned on the distal end of the shaft. The tip <NUM> can have any size or shape that guides the distal end <NUM> through the carpal tunnel area. In this first embodiment, the tip <NUM> has a pointed configuration. Of course, the tip <NUM> can have any other desired configuration. In some embodiments, the tip <NUM> is an echogenic tip to improve visualization. In some cases, the echogenic tip includes an ultrasound probe and is sized and shaped to house an ultrasound probe.

The shaft <NUM> also includes a shaft opening <NUM>. The shaft opening <NUM> also extends for a distance longitudinally along the surface that is destined to be positioned adjacent to or in direct contact with the transverse carpal tunnel ligament. In this first embodiment, as best shown in <FIG>, the shaft opening <NUM> extends along the top surface <NUM> and two side surfaces <NUM>, <NUM> so that the shaft opening <NUM> is open superiorly, medially and laterally. This results in an "open" shaft opening <NUM>.

The shaft <NUM> also houses a blade <NUM>. The blade <NUM> includes a cutting edge <NUM> that is configured to cut a transverse carpal ligament. In this first embodiment, the cutting edge <NUM> is a distal most edge of the blade <NUM>. The cutting edge <NUM> can have any desired configuration that cuts a transverse carpal ligament. Here, the cutting edge <NUM> has a sharp angulated edge. However, this is not required and the cutting edge <NUM> can have any other desired configuration.

The shaft <NUM> also includes a blade guideway <NUM> that guides movement of the blade <NUM>. The blade guideway <NUM> can be configured as a guide rail or as a tunnel. In the illustrated embodiment, the blade guideway <NUM> is configured as a guide rail that extends in a direction parallel to the longitudinal axis x. Also, the guide rail is a substantially flat guide rail. Additionally, the shaft <NUM> includes a blade stop <NUM> that stops movement of the blade <NUM>. In some cases, the blade stop <NUM> is sized and shaped to receive the cutting edge <NUM>.

The blade <NUM> moves longitudinally along the "x" axis along the guide rail <NUM> in a forward distal direction and backward proximal direction. As the blade <NUM> moves forward distally, the cutting edge <NUM> moves towards the blade stop <NUM>. Likewise, as the blade <NUM> moves backward proximally, the cutting edge <NUM> moves away from the blade stop <NUM>. The blade <NUM> can perform cutting as an operator moves the blade proximally or distally or both.

The shaft <NUM> also includes one or more balloons that expand or inflate radially outwardly from the shaft <NUM>. This first embodiment illustrates two lateral balloons 34a, 34b. The balloons 34a, 34b inflate and expand outward laterally from the shaft <NUM>. Likewise, the balloons 34a, 34b deflate and shrink inwardly toward the shaft <NUM>. When inflated, the balloons 34a, 34b have a spherical, oval, bilobular or other configuration. When deflated, the balloons 134a, 34b are generally flush with the shaft <NUM>.

Skilled artisans will understand that any number of radially expanding balloons can be used and be placed anywhere about the shaft <NUM> to secure the distal end <NUM> in position within the carpal tunnel region and to expand the "safe zone. " As the radially expanding balloons inflate, they move the flexor tendons, median nerve, and ulnar neurovascular bundle away from the device <NUM>, effectively increasing the "safe zone. " This helps to ensure that only the transverse carpal ligament is cut and that nearby at-risk structures are not cut.

In some embodiments, the distal tip <NUM> includes one or more balloons that expand radially outward from the distal tip <NUM>. The first embodiment does not use such a distal tip balloon. However, skilled artisans will understand that such a distal tip balloon can be used to increase the distal "safe zone" between the tip and the superficial palmar arch and/or further pushes the tip superiorly (i.e. palmarly) to engage the distal end of the transverse carpal ligament.

The balloons 34a, 34b can also be inflated and deflated using a number of different techniques. In some cases, an inflation device supplies an inflation material to the balloons. The inflation material can be a gas (e.g., air) or a fluid or liquid (e.g., water or saline).

The inflation device supplies inflation material to the balloons 34a, 34b using any desired arrangement. In some cases, the shaft includes one or more conduits operably coupled to both the balloons and the inflation device to deliver and remove gas/fluid to and from the balloons. In the first embodiment, the shaft <NUM> includes a conduit <NUM> that delivers and removes gas or fluid from the balloons 34a, 34b. Of course, skilled artisans will understand that other conduit arrangements and other mechanisms of inflating and deflating the balloons 34a, 34b can be used.

The balloons 34a, 34b can be made expandable using any number of desired configurations. In some cases, the entire balloon is expandable and thus inflates and deflates. In other cases, only part of the balloon is expandable. For example, the balloon can have a fixed portion and an expandable portion. The fixed portion can be the portion that directly attaches to a conduit whereas the expandable portion does not directly attach to a conduit and instead expands freely of the conduit.

The balloons 34a, 34b also inflate to a desired size selected to accommodate the size of a patient's wrist (and thus the patient's carpal tunnel region). For example, in some cases, the balloons can be provided with a specific size such that when they are fully inflated, they have a specific inflated size. In one embodiment, each of the balloons 34a, 34b inflate to a similar or same diameter (e.g., a diameter of about <NUM>). In patients with larger wrists, larger balloons can be used. In patients with smaller wrists, smaller balloons can be used. In another embodiment one of the balloons 34a, 34b inflates to one size and the other inflates to a different size. In other cases, the balloons 34a, 34b can have a standard size but can be partially inflated or fully inflated to have a variety of different inflated sizes. In some cases, the balloon inflation can be graded to allow the operator to choose a particular balloon diameter. In certain cases, the balloon inflation can be pressure dependent, such that the balloon manually or automatically inflates until a specific pressure is exerted on the balloon surface.

<FIG>, <FIG> and <FIG> show the distal end <NUM> in an inactive position. In the inactive position, the blade <NUM> is positioned such that its cutting edge <NUM> is protected within with the shaft <NUM> and is positioned proximally from the "open" shaft opening <NUM>. The balloons 34a, 36b are also deflated. In this inactive position, the blade <NUM> is not exposed and does not pose and risk to the operator or the patient. Thus, the operator inserts and removes the distal end <NUM> into and from the carpal tunnel region when it is in the inactive position.

<FIG>, <FIG> and <FIG> show the distal end <NUM> in an active position. In the active position, the blade <NUM> is positioned such that its cutting edge <NUM> is within the shaft opening <NUM>. In the active position, the blade <NUM> is exposed and is able to cut the transverse carpal ligament. The balloons 34a, 34b are also inflated to anchor the distal end <NUM> in position within the body and to expand the "safe zone" while the blade <NUM> performs cutting.

During use, an operator inserts the distal end in an inactive position into the carpal tunnel region so that the transverse carpal ligament is positioned within the shaft opening <NUM> and the tip <NUM> is hooked around a distal end of the transverse carpal ligament. The operator then activates a control to cause the balloons 34a, 34b to inflate. The inflated balloons 34a, 34b stabilize the distal end <NUM> in position within the carpal tunnel region and expand the "safe zone.

The operator next activates a control to cause the blade <NUM> cut the transverse carpal ligament. In one embodiment, the operator moves the blade <NUM> backward distally along the guideway <NUM> so that its cutting edge <NUM> moves backward away from the blade stop <NUM> and into the covered shaft <NUM>. As the blade <NUM> moves proximally, the cutting edge <NUM> cuts the transverse carpal ligament that is positioned within the shaft opening <NUM>. Once the cutting edge <NUM> moves into the covered shaft <NUM>, the ligament is completely cut. The operator can repeat this process as necessary.

In another embodiment, the operator activates a control to cause the blade <NUM> to move forward distally along the guideway <NUM> so that its cutting edge <NUM> moves toward the blade stop <NUM>. As the blade <NUM> moves distally, the cutting edge <NUM> cuts the transverse carpal ligament that is positioned within the shaft opening <NUM>. The blade stop <NUM> stops the cutting edge <NUM> from moving any further distally. Once the cutting edge <NUM> engages the blade stop <NUM>, the ligament is completely cut. The operator can then repeat this process as necessary.

Once the transverse carpal ligament has been cut and the blade <NUM> is moved back into the covered shaft <NUM>, the operator then activates a control to cause the balloons 34a, 34b to deflate. The distal end <NUM> resumes an inactive position and the operator can then safely remove the distal end <NUM> from the body.

<FIG> illustrate views of a transverse carpal ligament cutting device <NUM> according to the present invention. The device <NUM> has a proximal end (not shown) and a distal end <NUM> that inserts into the carpal tunnel region. The proximal end <NUM> includes a single-hand handpiece according to any desired configuration. The single-hand handpiece <NUM> has a configuration that allows an operator to operate the device <NUM> using a single hand only. Skilled artisans will understand that the handpiece can have any of the embodiments described herein for a handpiece, including the handpiece shown in each of <FIG>, <FIG>, <FIG> and <FIG>.

The proximal end is coupled to a shaft <NUM> that extends distally towards a distal end <NUM>. The shaft <NUM> can have any embodiment already described for shaft <NUM>. The proximal end can have any desired configuration to allow an operator to control various functions on the distal end <NUM>. The distal end <NUM> includes a shaft <NUM>, a tip <NUM>, a shaft opening <NUM>, a blade <NUM>, an optional blade base plate <NUM>, a blade elevator balloon <NUM>, a first lateral balloon 134a, a second lateral balloon 134b, a dorsal balloon <NUM> and a plurality of suction holes <NUM>. Each of these components work together to safely cut a transverse carpal ligament in a carpal tunnel region.

The distal end <NUM> includes a shaft <NUM> that has a size and cross-section shape that is suitable for being inserted into the carpal tunnel region. The shaft <NUM> extends longitudinally along a longitudinal axis "x. " The shaft <NUM> has a top surface <NUM>, side surfaces <NUM>, <NUM>, and a bottom surface <NUM>. In this second embodiment, the shaft <NUM> has a non-circular cross-section such that top surface <NUM> includes a single top wall and the side surfaces <NUM>, <NUM> and the bottom surface <NUM> includes a curved side wall. Of course, skilled artisans will understand that the shaft <NUM> can include any other desired cross-section and that each shaft surface can include any desired number of side walls.

The distal end <NUM> includes a tip <NUM>. The tip <NUM> is the distal-most end of the device <NUM> and is positioned distally to the shaft <NUM>. In some cases, the tip <NUM> is an extension of the shaft <NUM>. In other cases, the tip <NUM> is a separate piece that is positioned on the distal end <NUM> of the shaft <NUM>. The tip <NUM> can have any size or shape that guides the distal end <NUM> through the carpal tunnel area. In this second embodiment, the tip <NUM> has a conical configuration. Again, skilled artisans will understand that the tip <NUM> can have any other desired configuration. In some embodiments, the tip <NUM> is an echogenic tip that includes an ultrasound probe and is sized and shaped to house an ultrasound probe.

The shaft <NUM> also includes a shaft opening <NUM>. The shaft opening <NUM> also extends for a distance longitudinally along the "x" axis. The shaft opening <NUM> extends along a surface that is destined to be positioned in direct contact with the transverse carpal ligament. In this second embodiment, the top surface <NUM> is the surface that is destined to be positioned in direct contact with the transverse carpal ligament. As such, the shaft opening <NUM> extends along the top surface <NUM> only so that the shaft opening <NUM> is only open superiorly. This results in a "closed" shaft opening <NUM>.

The shaft <NUM> also houses a blade <NUM>. The blade <NUM> includes a cutting edge <NUM> that is configured to cut a carpal tunnel ligament. In this second embodiment, the cutting edge <NUM> is a top edge of the blade <NUM>. The cutting edge <NUM> can have any desired configuration that cuts soft tissue. Here, the cutting edge <NUM> has a sharp straight edge. The cutting edge <NUM> can also have any desired length.

The shaft <NUM> also includes an optional blade base plate <NUM> that supports the blade <NUM>. The blade base plate <NUM> attaches to the blade <NUM> along a bottom edge of the blade. Also, a blade elevator balloon <NUM> is positioned beneath the blade base plate <NUM>. In some embodiments, the blade <NUM> is connected directly to the blade elevator balloon <NUM> (and there is no blade base plate <NUM>). The blade elevator balloon <NUM> can have any desired configuration, such as a spherical or bilobular configuration.

When the blade elevator balloon <NUM> inflates, it expands upward, thus moving the blade base plate <NUM> (if included) and the blade <NUM> upward. The top cutting edge <NUM> moves upward through the opening <NUM> and cuts the overlying transverse carpal ligament. When the blade elevator balloon <NUM> deflates, it shrinks downward, thus moving the blade base plate <NUM> (if included) and the blade <NUM> downward until it is again protected within the shaft <NUM>. The blade elevator balloon <NUM> can have any desired configuration and size so that it can move the base plate <NUM> and/or the blade elevator balloon <NUM> upward and downward.

The shaft <NUM> also includes a conduit <NUM> that delivers and removes gas or fluid to and from the blade elevator balloon <NUM>. Of course, skilled artisans will understand that other conduit arrangements and other mechanisms of inflating and deflating the blade elevator balloon <NUM> can be used.

The blade <NUM> can be elevated to any desired degree. The degree of elevation also determines the degree of cutting of the overlying transverse carpal ligament. An operator can vary and individualize the degree of cutting of the transverse carpal ligament by varying the degrees of the balloon elevator expansion <NUM> and thus the base plate <NUM> elevation.

The distal end <NUM> also includes a first lateral balloon 134a and a second lateral balloon 134b. The distal end <NUM> also includes a dorsal balloon <NUM>. The balloons 134a, 134b, <NUM> inflate and expand outward laterally from the device <NUM>. Likewise, the balloons 134a, 134b, <NUM> deflate and shrink inwardly toward the device <NUM>. When inflated, the balloons 134a, 134b, <NUM> have a spherical, oval, bilobular or other configuration. When deflated, the balloons 134a, 134b, <NUM> are generally flush with the distal end <NUM>.

This embodiment illustrates two lateral balloons and one dorsal balloon. However, skilled artisans will understand that any number of balloons can be used and the balloons can be placed anywhere about the shaft to secure the distal end <NUM> in position within the carpal tunnel region and to expand the "safe zone.

The balloons 134a, 134b, <NUM> also inflate to a desired size selected to accommodate the size of a patient's wrist (and thus the patient's carpal tunnel region). For example, in some cases, the balloons 134a, 134b, <NUM> can be provided with a specific size such that when they are fully inflated, they have a specific inflated size. In one embodiment, each of the balloons 134a, 134b, <NUM> inflate to a similar or same diameter (e.g., a diameter of about <NUM>). In patients with larger wrists, larger balloons can be used. In patients with smaller wrists, smaller balloons can be used. In another embodiment one of the balloons134a, 134b, <NUM> inflates to one size and another inflates to a different size. In other cases, the balloons 134a, 134b, <NUM> can have a standard size but can be partially inflated or fully inflated to have a variety of different inflated sizes. In some cases, the balloon inflation can be graded to allow the operator to choose a particular balloon diameter. In certain cases, the balloon inflation can be pressure dependent, such that the balloon manually or automatically inflates until a specific pressure is exerted on the balloon surface.

The shaft <NUM> also includes a conduit <NUM> that delivers and removes gas or fluid from the balloons 134a, 134b, <NUM>. An inflation device (not shown) supplies inflation material such as gas, fluid, water or air to the conduit <NUM>. The inflation device also retracts inflation material from the balloons 134a, 134b, <NUM> back through the conduit <NUM> and back into the inflation device. Of course, skilled artisans will understand that other conduit arrangements and other mechanisms of inflating and deflating the balloons 134a, 134b, <NUM> can be used. For example, in some cases, a separate conduit can connect each balloon to an inflation device. Here then, each the balloons 134a, 134b, <NUM> would be connected to an inflation device via its own conduit.

The shaft <NUM> further includes a plurality of suction openings <NUM>. In some cases, the suction openings <NUM> can be provided along a shaft surface that is destined to be positioned in direct contact with the transverse carpal ligament. In the second embodiment, the top surface <NUM> is the surface that is destined to be positioned in direct contact with the transverse carpal ligament. As such, the suction openings138 can be provided along the top surface <NUM>.

The suction openings <NUM> can have any desired configuration. In the second embodiment, the suction openings <NUM> are circular holes. Of course, the suction openings <NUM> can have any other desired shapes such as a plurality of slots or a single slot.

Suction is applied to the suction openings <NUM> to suck air through the suction openings <NUM>. This causes the transverse carpal ligament to move closer to the top surface <NUM>. Suction can be applied to the suction openings <NUM> using any desired mechanism. In some cases, the shaft <NUM> includes a vacuum conduit <NUM> that sucks air through the suction openings <NUM>. Skilled artisans will understand that one or more conduits can be operably coupled to the suction openings to apply suction to the suction openings <NUM>. In some cases, a single conduit is used to apply suction to the suction openings <NUM>. In other cases, a plurality of conduits can be used. For example, a first conduit can apply suction to some of the suction openings <NUM> and a second conduit can apply suction to other of the suction openings <NUM>. Skilled artisans will understand that any arrangement of conduits can be used.

<FIG>, <FIG> and <FIG> show the distal end <NUM> in an inactive position. In the inactive position, the blade <NUM> is positioned such that its cutting edge <NUM> is protected within with the shaft <NUM>. The balloons <NUM>, 134a, 134b, <NUM> are also deflated. In this inactive position, the blade <NUM> is not exposed and does not pose and risk to the operator or the patient. Thus, the operator inserts and removes the distal end <NUM> into and from the carpal tunnel region when it is in the inactive position.

<FIG>, <FIG> and <FIG> show the distal end <NUM> in an active position. In the active position, blade elevator balloon <NUM> is inflated and the blade <NUM> is positioned such that its top cutting edge <NUM> extends through the superior shaft opening <NUM> and is exposed. In the active position, the blade <NUM> is exposed and is able to cut the transverse carpal ligament. The balloons 134a, 134b, <NUM> are also inflated to anchor the distal end <NUM> in position within the body and to expand the patient's safe zone while the blade <NUM> performs cutting.

During use, an operator inserts the distal end <NUM> into a carpal tunnel region such that the transverse carpal ligament is positioned adjacent the working side <NUM> of the distal end <NUM>. The operator then activates a control to cause the balloons 134a, 134b, <NUM> to inflate and to expand the safe zone within the carpal tunnel region. The operator next activates a control to suck air through the suction openings <NUM>. Again, this is turn pulls the transverse carpal ligament towards the top surface <NUM> to optimize contact between the top surface <NUM> and the transverse carpal ligament.

The operator next activates a control to cause the balloon elevator to expand so that the cutting edge <NUM> moves upward through the opening <NUM> and cuts into the transverse carpal ligament. The depth of the cut can be varied by modulating the extent of the blade elevator balloon <NUM> inflation. In general, <NUM>-<NUM> of upward displacement is sufficient to cut the transverse carpal ligament. The ligament may be completely cut by the upward motion, or may be partially cut/fenestrated by reducing the amount of blade elevation and/or using a blade having a serrated or saw tooth cutting edge <NUM>.

In some cases, once the cutting edge <NUM> is engaged with the transverse carpal ligament, the operator can manually move the entire device <NUM> forward distally and backward proximally to impart a sawing motion, as necessary or desired. However, the amplitude of anticipated operator motion should be small given the stabilizing properties of the device.

Once the transverse carpal ligament is cut, the operator activates controls to stop the suction through the suction holes and to deflate all the balloons 134a, 134b, <NUM>. This causes the blade <NUM> to move back downward into the shaft <NUM>. The operator then safely removes the distal end <NUM> from the body.

<FIG> illustrate views of a transverse carpal ligament cutting device <NUM> according to another embodiment. Referring to <FIG>, the device <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> includes a handle <NUM>. The distal end <NUM> includes a shaft <NUM> that inserts into the carpal tunnel region. The handle <NUM> includes a blade activation assembly <NUM>. The device <NUM> also includes an inflation assembly <NUM> coupled to the handle <NUM>. The inflation assembly <NUM> and blade activation assembly <NUM> each control various functions of the shaft <NUM> at the distal end <NUM>.

Referring to <FIG>, the distal end <NUM> includes a shaft <NUM>, a tip <NUM>, a shaft opening <NUM>, a blade <NUM>, a first balloon 234a and a second balloon 234b. The shaft <NUM> can also include a shaft cover <NUM>. The shaft <NUM> also has a size and cross-section shape that is suitable for being inserted into the carpal tunnel region. The shaft <NUM> extends longitudinally along a longitudinal axis "x. " The shaft <NUM> has a top surface <NUM>, side surfaces 240a, 240b, and a bottom surface <NUM>. The shaft <NUM> can also have any embodiment described for shaft <NUM> or shaft <NUM>.

The distal end <NUM> includes a tip <NUM>. The tip <NUM> is the distal-most end of the device <NUM> and is positioned distally to the shaft <NUM>. In some cases, the tip <NUM> is an extension of the shaft <NUM>. In other cases, the tip <NUM> is a separate piece that is positioned on the distal end of the shaft <NUM>. The tip <NUM> can have any size or shape that guides the distal end <NUM> through the carpal tunnel area. In this embodiment, the tip <NUM> has a rounded configuration. Of course, the tip <NUM> can have any other desired configuration. In some embodiments, the tip <NUM> is an echogenic tip that includes an ultrasound probe and is sized and shaped to house an ultrasound probe.

The shaft <NUM> also includes a shaft opening <NUM>. The shaft opening <NUM> also extends for a distance longitudinally along the surface that is destined to be positioned adjacent to or in direct contact with the transverse carpal tunnel ligament. In this embodiment, as shown in <FIG>, the shaft opening <NUM> extends along the top surface <NUM> so that the shaft opening <NUM> is open superiorly.

The shaft <NUM> also houses a blade <NUM>. Referring to <FIG>, the blade <NUM> includes a blade shaft <NUM> and a blade working end <NUM>. The blade shaft <NUM> engages with a blade activation assembly <NUM> to move the blade <NUM> forward and backward. The blade working end <NUM> is the end that is configured to cut a transverse carpal ligament.

<FIG> illustrate a blade working end <NUM> according to an embodiment. In this embodiment, the blade working end <NUM> is configured as a hook. The hook includes an outer surface <NUM> and an inner surface <NUM> that come together at a point <NUM>. The inner surface <NUM> includes a cutting edge <NUM>. The cutting edge <NUM> thus includes a non-linear edge. Instead the cutting edge <NUM> includes a curved edge. In other embodiments, the blade working end is configured as an angled blade having an outer surface and an inner surface. The inner surface includes an angled cutting edge.

The outer surface <NUM> does not include a cutting edge. Rather, at least part of the entire outer surface <NUM> (or substantially the entire outer surface <NUM> or the entire outer surface <NUM>) is a dull and/or blunt surface that would not cut body tissue. Likewise, the point <NUM> is configured as a tip that would not cut body tissue. In other words, the point <NUM> does not have any exposed sharp edges that would cut body tissue. In some cases, the point <NUM> is a blunt point and/or a dull point and/or a rounded point.

The blade working end <NUM> also includes a blade pin <NUM>. The blade pin <NUM> is positioned on the blade working end <NUM> such that the pin <NUM> moves along a blade guideway <NUM> (described below). In some embodiments, the blade pin <NUM> is positioned along the outer surface <NUM>. The blade pin <NUM> can be mechanically or weldedly attached to the blade working end <NUM>. In other embodiments, the blade pin <NUM> is provided as part of or integral to the blade working end <NUM> and is not a separate piece.

Referring to <FIG>, the shaft <NUM> also includes a blade guideway <NUM> that guides movement of the blade <NUM>. An operator moves the blade <NUM> forward and backward along the blade guideway <NUM>. The blade guideway <NUM> can be any guide, groove, track or tunnel that guides the forward and rearward movement of the blade <NUM>. The blade guideway <NUM> includes a distal guideway end <NUM>, a distal incline <NUM>, a plateau <NUM>, a proximal incline <NUM> and a proximal guideway end <NUM>. As shown, the plateau <NUM> is positioned between two inclines <NUM>, <NUM>. Also, the distal incline <NUM> is positioned between the distal guideway end <NUM> and the plateau <NUM>. Further, the proximal incline <NUM> is positioned between the proximal guideway end <NUM> and the plateau <NUM>. The distal incline <NUM> and proximal incline <NUM> can be configured as inclines or ramps having any desired slope. In some cases, the distal incline <NUM> and proximal incline <NUM> each have a slope angle of between O° and <NUM>°. In certain cases, the distal incline <NUM> and proximal incline <NUM> each have a slope angle of between <NUM>° and <NUM>°.

The blade <NUM> includes a blade pin <NUM> that moves within or along the blade guideway <NUM>. <FIG> illustrate a path of the blade pin <NUM> as it moves along the blade guideway <NUM>. In <FIG>, the blade pin <NUM> is positioned at the distal guideway end <NUM>. As shown in <FIG>, the operator moves the blade <NUM> backward to move the blade pin <NUM> up the distal incline <NUM>. As shown in <FIG>, the operator continues to move the blade <NUM> backward so that the blade pin <NUM> moves backward along the plateau <NUM>. Once the blade pin <NUM> reaches the proximal incline <NUM>, it moves down the proximal incline <NUM> until it reaches the proximal guideway end <NUM>, as shown in <FIG>.

When the blade pin <NUM> is positioned at the distal guideway end <NUM>, as shown in <FIG>, the cutting edge <NUM> of the blade <NUM> is housed within the shaft <NUM> and is not exposed through the shaft opening <NUM>. Likewise, when the blade pin <NUM> is positioned at the proximal guideway end <NUM>, as shown in <FIG>, the cutting edge <NUM> is housed within the shaft <NUM> and is not exposed through the shaft opening <NUM>. When the cutting edge is housed within the shaft <NUM>, the device <NUM> is in an inactive or protected position.

On the other hand, when the blade pin <NUM> is positioned along the plateau <NUM>, as shown in <FIG>, the cutting edge <NUM> of the blade <NUM> extends through the shaft opening <NUM> and is exposed. In this case, the device <NUM> is in an active position and is able to cut soft tissue.

Referring back to <FIG>, the shaft <NUM> also includes one or more balloons that expand radially outwardly from the shaft <NUM>. The balloons can be positioned anywhere about the shaft <NUM> such that they expand the safe zone of the carpal tunnel region. This embodiment illustrates two lateral balloons 234a, 234b that are positioned on sides 240a, 240b of the shaft <NUM>. The balloons 234a, 234b inflate and expand outward laterally from the shaft <NUM>. Likewise, the balloons 234a, 234b deflate and shrink inwardly toward the shaft <NUM>. When inflated, the balloons 234a, 234b have a spherical, oval, bilobular or other configuration. When deflated, the balloons 234a, 234b can be generally flush with the shaft <NUM>.

The shaft <NUM> also optionally includes a first channel 230a and a second channel 230b. The first lateral balloon 234a can be positioned so that it lies within the first channel 230a. Likewise, the second lateral balloon 234b can be positioned so that it lies within the second channel 230b. The channels 230a, 230b can have any size and shape that accommodates the balloons 234a, 234b.

The device <NUM> also includes a blade activation assembly <NUM>. <FIG> illustrate an embodiment of a blade activation assembly <NUM>. The blade activation assembly <NUM> includes a slider button <NUM>, a first plate <NUM>, a second plate <NUM>, a plate pin <NUM>, a first screw 278a, a second screw 278b, a blade latch <NUM>, a blade latch pin <NUM> and a ball <NUM>. The slider button <NUM> is positioned on an external surface of the handle <NUM>. An operator engages the slider button <NUM> with a finger (for example by engaging a thumb with the slider button <NUM>). The operator pulls the slider button <NUM>, which allows the guide pin <NUM> to slide away from the distal guideway <NUM> within the guideway incline <NUM> until reaching the end point of the proximal guideway <NUM>. The slider button <NUM> can move in both forward and backward directions to move the blade <NUM> forward and backward.

The device <NUM> also includes an inflation assembly <NUM>. The inflation assembly <NUM> includes the first balloon 234a, a first conduit 286a, the second balloon 234b, a second conduit 286b, and an inflation device <NUM>. The inflation device <NUM> can be provided inside of the handle <NUM> and/or provided outside of the handle <NUM>. <FIG> illustrates an embodiment of an inflation assembly <NUM> that is provided outside of the handle <NUM>. Skilled artisans will also understand that the inflation assembly <NUM> described in this embodiment can also be included in any of the other device embodiments (e.g., device <NUM>, <NUM>) described herein.

The first conduit 286a connects the first balloon 234a to the inflation device <NUM>. Likewise, the second conduit 286b connects the second balloon 236b to the inflation device <NUM>. The inflation device <NUM> supplies inflation material such as gas, fluid, water or air to each the first conduit 286a and second conduit 286b, which in turn supply the inflation material to the first balloon 234a and the second balloon 234b. The inflation material causes the first balloon 234a and the second balloon 234b to inflate. The inflation device <NUM> also retracts inflation material from the first balloon 234a and second balloon 234b back through the first conduit 286a and second conduit 286b and back into the inflation device <NUM>. Thus, the inflation device <NUM> inflates and deflates the balloons 234a, 234b.

In some embodiments, the first conduit 286a and the second conduit 286b directly connect to the inflation device <NUM>. In other embodiments, a piping arrangement <NUM> is provided between the first conduit 286a, the second conduit 286b and the inflation device <NUM>. For example, as shown in <FIG>, each the first conduit 286a and the second conduit 286b connect to a coupling <NUM>. In some cases, the coupling <NUM> is a y-shaped coupling that splits inflation material into the first conduit 286a and second conduit 286b when the material is moving towards the balloons 234a, 234b. Likewise, the coupling <NUM> can combine inflation material from the first conduit 286a and the second conduit 286b into a single conduit <NUM> when the material is moving back towards the inflation device <NUM>. Such a piping arrangement <NUM> can provide increased efficiency of movement of the inflation material.

The first balloon 234a connects to the first conduit 286a and the second balloon connects 234b to the second conduit 286b. In some embodiments, the first balloon 234a directly attaches to the first conduit 286a and the second balloon 234b directly attaches to the second conduit 286b, although this is not required. In certain cases, the first conduit 286a is positioned inside of the first balloon 234a and the second conduit 286b is positioned inside of the second balloon 234b. Each conduit 286a, 286b includes a plurality of openings <NUM> that open into the balloons 234a, 234b.

<FIG> illustrates one embodiment showing a conduit positioned inside of a balloon. In <FIG>, the second conduit 286b is shown positioned inside of the second balloon 234b. The second conduit 286b includes a plurality of openings <NUM> that open into the inside of the second balloon 234b. Inflation material moves in and out of these openings <NUM>. Although not seen in <FIG>, the first balloon 234a can connect to the first conduit 286a in a similar or identical manner.

The balloons 234a, 234b can have any desired configuration that allows them to inflate and deflate. In some embodiments, the entire balloon is expandable and thus inflates and deflates. In other embodiments, only part of the balloon is expandable. For example, the balloon can have a fixed portion and an expandable portion. <FIG> illustrates an embodiment wherein the balloon 234b has a fixed portion and an expandable portion <NUM>. The fixed portion <NUM> can be the portion that directly attaches to conduit 286b whereas the expandable portion <NUM> does not directly attach to the conduit 286b and instead expands freely of the conduit 286b.

The balloons 234a, 234b also inflate to a desired size selected to accommodate the size of a patient's wrist (and thus the patient's carpal tunnel region). For example, in some cases, the balloons 234a, 234b can be provided with a specific size such that when they are fully inflated, they have a specific inflated size. In one embodiment, each of the balloons 234a, 234b inflate to a similar or same diameter (e.g., a diameter of about <NUM>). In patients with larger wrists, larger balloons can be used. In patients with smaller wrists, smaller balloons can be used. In another embodiment one of the balloons 234a, 234b inflates to one size and another inflates to a different size. In other cases, the balloons 234a, 234b can have a standard size but can be partially inflated or fully inflated to have a variety of different inflated sizes. In some cases, the balloon inflation can be graded to allow the operator to choose a particular balloon diameter. In certain cases, the balloon inflation can be pressure dependent, such that the balloon manually or automatically inflates until a specific pressure is exerted on the balloon surface.

The inflation device <NUM> can be any desired device known in the art that holds inflation material and both pushes inflation material out of the inflation device <NUM> and pulls inflation material back into the inflation device <NUM>. In <FIG>, the inflation device <NUM> is a syringe <NUM>. Skilled artisans will understand that the illustrated syringe <NUM> is merely one embodiment of an inflation device <NUM> and that other devices are suitable. Also, in the illustrated embodiment, the syringe <NUM> is provided outside of the handle <NUM>. However, skilled artisans will understand that the syringe <NUM> can instead be provided inside of the handle <NUM>. The syringe <NUM> can be provided by itself or as part of a syringe control assembly (e.g., as a part of a syringe control assembly <NUM> described with reference to <FIG>).

The syringe <NUM> includes a barrel <NUM> and a plunger <NUM>. The syringe <NUM> holds fluid inside of the barrel <NUM>. When the operator desires to inflate the balloons 234a, 234b, he or she pushes the plunger <NUM> to push fluid into the piping arrangement <NUM> (or directly into the conduits 286a, 286b). The fluid moves into the conduits 286a, 286b and exits through the openings <NUM> into the balloons 234a, 234b. When the operator desires to deflate the balloons 234a, 234b, he or she pulls or retracts the plunger <NUM> to pull fluid back towards the inflation device <NUM>. This causes fluid to move out of the balloons 234a, 234b through the openings <NUM> and back into the conduits 286a, 286b.

During use, an operator first obtains a device <NUM> that is in the first inactive position. In the first inactive position, the device <NUM> has its blade <NUM> positioned such that the blade pin <NUM> is positioned at the distal guideway end <NUM> of the blade guideway <NUM> as shown in <FIG>. The cutting edge 254is fully housed and protected within the shaft <NUM> and the device <NUM> can be safely inserted into a carpal tunnel region. The device <NUM> also has its balloons 234a, 234b in a deflated configuration. The operator inserts the distal end <NUM> into a carpal tunnel region such that the transverse carpal ligament is positioned adjacent the top surface <NUM> of the shaft <NUM>. The operator then activates a control to cause the balloons 234a, 234b inflate and to expand the safe zone within the carpal tunnel region.

The operator next moves the slider button <NUM> backward to move the blade working end backward and up the distal incline <NUM> as shown in <FIG>. Once the blade working end reaches the plateau as shown in <FIG>, the cutting edge <NUM> is fully exposed and able to cut the transverse carpal ligament. The operator continues to move the slider button <NUM> backward to move the blade working end (and cutting edge) backward along the plateau <NUM>. As the cutting edge <NUM> moves backward, it cuts the transverse carpal ligament.

The operator continues to move the slider button <NUM> backward to move the blade working end backward and down the proximal incline <NUM>. The blade <NUM> stops moving backward once the blade pin <NUM> reaches the proximal guideway end <NUM> as shown in <FIG>. Once the blade pin <NUM> reaches the proximal guideway end <NUM>, the transverse carpal ligament is cut and the device <NUM> is in the second inactive position. The operator then activates a control to cause the balloons 234a, 234b to deflate. In this second inaction position, the device <NUM> has its blade <NUM> positioned such that the blade pin <NUM> is positioned at the proximal guideway end <NUM> of the blade guideway <NUM> as shown in <FIG>. The cutting edge <NUM> is fully housed and protected within the shaft <NUM> and the device <NUM> can be safely removed from the body.

In certain embodiments, the handle also houses the syringe. In such cases, the syringe includes an actuator or control positioned outside of the handle that controls functions of the syringe. For example, the control can be a lever, slider button, push button and/or clamp. In some cases, the control is another slider button positioned on an external surface of the handle. The slider button can be coupled to a plunger to control movement of the plunger. In some cases, the slider button is directly connected to the plunger. In other cases, the control is a clamp. In such cases, the clamp can be coupled to a plunger to control movement of the plunger. When an operator desires to inflate the balloons, he or she slides the slider button forward (or compresses the clamp) to push the plunger and push fluid from the barrel into a piping arrangement. When the operator desires to deflate the balloons, he or she slides the slider button backward (or decompresses the clamp) to retract the plunger and retract fluid back into the barrel.

<FIG> illustrate views of a transverse carpal ligament cutting device <NUM> according to another embodiment. Referring to <FIG>, the device <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> includes a handle <NUM>. The distal end <NUM> includes a shaft that inserts into the carpal tunnel region. The handle <NUM> includes a blade activation assembly <NUM>. The device <NUM> also includes an inflation assembly <NUM> coupled to the handle <NUM>. The inflation assembly <NUM> and blade activation assembly <NUM> each control various functions of the shaft at the distal end <NUM>.

The soft tissue cutting device or transverse carpal ligament cutting device <NUM> includes a distal end <NUM> including a shaft. In some embodiments, the distal end <NUM> can be in accordance with the distal end <NUM> already described with reference to <FIG> and <NUM>-<NUM>. In such cases, the distal end <NUM> includes one or more or all of the components and functions of distal end <NUM>.

The device <NUM> also includes a blade activation assembly <NUM>. In some embodiments, the blade activation assembly <NUM> can be in accordance with the blade activation assembly <NUM> already described with reference to <FIG>. In such cases, blade activation assembly <NUM> includes one or more or all of the components and functions of blade activation assembly <NUM>. Likewise, the blade activation assembly <NUM> can include a blade in accordance with the blade <NUM> already described with reference to <FIG> and <FIG>. In such cases, blade of device <NUM> includes one or more or all of the components and functions of blade <NUM>.

The device <NUM> also includes an inflation assembly <NUM>. The inflation assembly <NUM> includes one or more or all of the components and functions already described for the inflation assembly <NUM>. For example, in <FIG>, the inflation assembly <NUM> is shown as including at least the first balloon 234a, a first conduit 286a, the second balloon 234b and a second conduit 286b.

The inflation assembly <NUM> includes an inflation device. In some cases, the inflation device includes a syringe <NUM> that is part of a syringe control assembly <NUM>. <FIG> illustrate a syringe control assembly <NUM> according to one embodiment. The syringe control assembly <NUM> includes a clamp <NUM>, a syringe <NUM>, a decompression mechanism <NUM> and a compression mechanism <NUM>. Generally, when the operator desires to inflate the balloons 234a, 234b, he or she engages with the clamp <NUM> to cause the decompression mechanism <NUM> push fluid into the conduits 286a, 286b. When the operator desires to deflate the balloons 234a, 234b, he or she reengages with the clamp <NUM> to cause the compression mechanism <NUM> pull fluid back towards and into syringe <NUM>. This causes fluid to move out of the balloons 234a, 234b and back into the conduits 286a, 286b.

The syringe <NUM> includes a barrel <NUM> and a plunger <NUM>. The barrel <NUM> moves forward distally and backward proximally with respect to the plunger <NUM>. In some cases, the plunger <NUM> is fixed in position within the handle <NUM> and the barrel <NUM> moves forward distally and backward proximally with respect to the fixed plunger <NUM>.

In certain cases, the barrel <NUM> also includes a flange <NUM>. The flange <NUM> at least partially expands radially outward from the barrel <NUM>. In some cases, the flange <NUM> expands radially outwardly on a first side and a second side such that there is a first flange portion 338a on the first side and a second flange portion 338b on the second side.

The syringe control assembly <NUM> includes a decompression mechanism <NUM>. The clamp <NUM> is operably coupled to the decompression mechanism <NUM> such that when the clamp <NUM> is engaged, the decompression mechanism <NUM> causes the barrel <NUM> to move backward proximally with respect to the plunger <NUM>. This causes the plunger <NUM> to move deeper into the barrel <NUM>, thus pushing fluid in the barrel <NUM> out of the syringe <NUM> and into the balloon conduits. In some cases, the decompression mechanism <NUM> is operably coupled to a barrel holder <NUM> to move the first flange portion 338a and/or the second flange portion 338b forward distally and backward proximally.

The syringe control assembly <NUM> also includes a compression mechanism <NUM>. The clamp <NUM> is operably connected to the compression mechanism <NUM> such that when the clamp <NUM> is reengaged, the compression mechanism <NUM> causes the barrel to move forward distally with respect to the plunger <NUM>. This causes the plunger <NUM> to move out of the barrel <NUM> such that it pulls fluid out of the balloon conduits and back into the barrel <NUM>. In some cases, the compression mechanism <NUM> is operably coupled to a barrel plate <NUM> to move the first flange portion 338a and/or the second flange portion 338b forward distally and backward proximally.

In some embodiments, as best illustrated in <FIG>, the clamp <NUM> includes a hand-engaging portion <NUM> and an arm-connecting portion <NUM>. The arm-connecting portion <NUM> couples to an arm <NUM>. The arm <NUM> in turn couples to a connector <NUM>. In some cases, the arm <NUM> couples to the arm-connecting portion <NUM> via a connection <NUM>. Likewise, the arm-connecting portion <NUM> couples to the connector <NUM> via a connection <NUM>. Further, the connector <NUM> couples to the compression mechanism <NUM> via a connection <NUM>. In some cases, one or more or all of the connections <NUM>, <NUM>, <NUM> are hinged connections.

The compression mechanism <NUM> includes a lumen <NUM>, a spring <NUM> and a cap <NUM>. The lumen <NUM> includes a proximal end <NUM> and a distal end <NUM>. The lumen <NUM> also includes an outer surface <NUM>. The spring <NUM> is wound about the outer surface <NUM> of the lumen <NUM>. A cap <NUM> is positioned on the distal end <NUM> to secure the spring <NUM> in place on the outer surface <NUM>. Also, a barrel holder <NUM> is positioned on the proximal end <NUM>, also securing the spring <NUM> in place.

The barrel holder <NUM> connects to the barrel <NUM>. The barrel holder <NUM> connects to the second flange portion 338b. In some cases, the barrel holder <NUM> includes a groove <NUM> that retains the second flange portion 338b. The barrel holder <NUM> holds and moves the second flange portion 338b forward distally and resists movement backward proximally (thus moving the barrel <NUM> forward distally and resisting movement of the barrel <NUM> backward proximally).

The compression mechanism <NUM> also includes a piston <NUM>, a lumen <NUM> and a spring <NUM>. The lumen <NUM> also includes a proximal end <NUM> and a distal end <NUM> and an outer surface <NUM>. The spring <NUM> is positioned between the piston <NUM> and the proximal end <NUM> and is wound about the outer surface <NUM>. A barrel plate <NUM> is also positioned at the proximal end <NUM> to secure the spring <NUM> in place.

The barrel plate <NUM> also connects to the barrel <NUM>. In some cases, the barrel plate <NUM> connects to the first flange portion 338a. In some cases, the barrel plate <NUM> includes a groove <NUM> that receives the first flange portion 338a. The barrel plate <NUM> holds and moves the first flange portion 338a backward proximally (thus moving the barrel <NUM> backward proximally).

An operator first compresses or clamps the hand-engaging portion <NUM> of the clamp <NUM>, causing the arm-connecting portion <NUM> to move proximally via a pivot point within the arm-connecting portion <NUM> (not shown), which in turn pulls the arm <NUM> proximally. When the arm <NUM> moves proximally it acts on a lower portion of the connector <NUM> to move the lower portion proximally via a pivot point within the connector <NUM> (not shown). As the lower portion moves proximally, it causes the upper portion to move distally. The distal movement of the upper portion acts on the compression mechanism <NUM>. The flange connector <NUM> pushes the flange 338a proximally, thereby compressing the syringe <NUM>. The decompression mechanism <NUM> is also connected to the flange 338b via the barrel holder <NUM>. The decompression mechanism <NUM> resists compression of the syringe <NUM> via the spring <NUM>.

During use, an operator first obtains a device <NUM> that is in a first inactive position. In the first inactive position, the device <NUM> has its blade <NUM> positioned such that the blade cutting edge is protected within a shaft and the device <NUM> can be safely inserted into a carpal tunnel region. The device <NUM> also has its balloons in a deflated configuration. The inactive position can be any inactive position of the devices already described herein. The operator inserts the distal end <NUM> into a carpal tunnel region and then engages the clamp <NUM>, thus prompting the syringe control assembly <NUM> and causing the balloons inflate and to expand the safe zone within the carpal tunnel region. Once cutting is completed, the operator reengages the clamp <NUM>, thus prompting the syringe control assembly <NUM> to cause the balloons to deflate.

In some cases, the soft tissue cutting device also includes a safety mechanism. Such a safety mechanism can be provided in any of the embodiments already described. The safety mechanism prevents an operator from operating the device to deflate the balloons while the blade is active. In other words, the device has a locked position and an unlocked position. In the locked position, the balloons cannot be deflated. In the unlocked position, the balloons can be inflated.

Also, in some cases, the soft tissue cutting device includes an inflation device that includes multiple inflation levels. For example, in certain cases, the syringe of any of the embodiments described is a syringe that includes multiple compression levels. For example, the multiple compression levels can include a first compression level ("x" PSI), a second compression level ("x+" PSI), a third compression level ("x++" PSI) and so on. In some cases, the multiple compression levels also include a decompression level.

Certain examples, not forming part of the claimed invention, provide a soft tissue cutting method. The method can use any of the soft issue cutting devices described herein. In one embodiment, the method includes steps of providing a soft-tissue cutting device comprising: (a) a shaft, (b) a shaft opening in the shaft, (c) a blade that extends through and withdraws from the shaft opening, (d) one or more balloons coupled to the shaft that expand radially outward from the shaft. The method can further include steps of advancing the soft-tissue cutting device to a body region, expanding the one or more balloons radially outward and extending the blade through the shaft opening to cut the soft tissue.

Other examples, not forming part of the claimed invention, provide a method of cutting a transverse carpal ligament. The method can use any of the transverse carpal ligament cutting devices described herein. In one embodiment, the method includes the steps of providing a cutting device having an inactive position and an active position, wherein in the inactive position the device includes an unexposed blade and one or more deflated balloons and in the active position the device includes an exposed blade and one or more inflated radially-expanding balloons, advancing the device to a carpal tunnel region while the device is in the inactive position, and cutting a transverse carpal ligament while the device is in the active position.

Claim 1:
A soft tissue cutting device (<NUM>), comprising:
(a) a shaft (<NUM>) having a top surface (<NUM>), two side surfaces (<NUM>, <NUM>) and a bottom surface (<NUM>), the shaft (<NUM>) housing a blade (<NUM>) and a blade elevator balloon (<NUM>);
(b) a shaft opening (<NUM>) that extends for a distance along the top surface (<NUM>) of the shaft (<NUM>);
(c) the blade (<NUM>) having a cutting edge (<NUM>);
(d) the blade elevator balloon (<NUM>) coupled to the blade (<NUM>), wherein the blade elevator balloon (<NUM>) inflates to extend the cutting edge (<NUM>) through the shaft opening (<NUM>) and deflates to retract the cutting edge (<NUM>) through the shaft opening (<NUM>), and
wherein the blade elevator balloon (<NUM>) is configured to receive gas or fluid for inflating the blade elevator balloon (<NUM>) so as to extend the cutting edge (<NUM>) through the shaft opening (<NUM>); and
(e) one or more balloons (134a, 134b, 134c) coupled to the shaft (<NUM>) that are configured to expand radially outwardly from the shaft (<NUM>).