Patent Description:
The present invention relates generally to a micro-invasive surgical device. More specifically, the present invention relates to a micro-invasive tissue cutting device having a first blade and a second blade, wherein the second blade is rotatable relative to the first blade. The present disclosure also provides exemplary methods of using the tissue cutting device, including a method of treating trigger finger, in order to aid understanding of the invention.

The first annular ("A1") pulley is a small band of tissue on the palmar side of a person's hand. In some cases, the flexor tendon thickens and a nodule can get caught on the A1 pulley and cause irritation. The flexor tendon can then become locked in place when a person flexes his or her fingers. This condition is commonly referred to as "trigger finger. " To treat trigger finger, the A1 pulley is typically cut so as to release the tendon. For this purpose, certain devices are known that use a hook blade to perform such a procedure. However, a hook blade tends to slide off the tendon. Moreover, with such conventional devices, an additional, separate device is often required to introduce the hook blade into the person's skin.

As set forth in the present disclosure, it would be desirable to provide a tissue cutting device having a first blade and a second blade, wherein the second blade is rotatable relative to the first blade. In some cases, it would be desirable to provide such a device where the first blade facilitates introducing the tissue cutting device into and through a patient's skin. It would also be desirable to provide a device having a second blade that is protected by the first blade until the second blade is deployed for a cutting procedure. Additionally, it would be desirable to provide a tissue cutting device that is minimally invasive and that can be used to treat trigger finger. Still further, it would be desirable to provide a tissue cutting device having a lock for selectively controlling rotation of the second blade relative to the first blade. Further yet, it would be desirable to provide a tissue cutting device having one or more break points between the first blade and the second blade, wherein the one or more break points are configured to be disrupted. <CIT>, <CIT> and <CIT> disclose devices of the prior art.

Claim <NUM> defines the invention and dependent claims disclose embodiments. No surgical methods are claimed per se.

The following detailed description is to be read with reference to the drawings, in which like elements in different drawings have like reference numerals. Skilled artisans will recognize that the examples provided herein have many useful alternatives that fall within the scope of the invention.

Referring to the drawings, and in particular, <FIG>, there is shown a tissue cutting device of the present disclosure generally represented by reference numeral <NUM>. The tissue cutting device <NUM> can be used to cut any desired soft tissue structure in the body (e.g., of a human or non-human mammal). Such soft tissue structure includes, but is not limited to, a ligament, fascia, or tendon. In certain preferred embodiments, the tissue cutting device <NUM> is used to cut an A1 pulley.

In some embodiments, the tissue cutting device <NUM> includes a handle <NUM>, a first blade <NUM>, and a second blade <NUM> that collectively define a blade assembly. The first blade <NUM> is coupled to the second blade <NUM> and both blades <NUM>, <NUM> are coupled to the handle <NUM>. The first blade <NUM> is an exposed blade. As used in the present disclosure, an exposed blade refers to a blade that is not protected from contact with tissue. In contrast, an unexposed blade, as used in the present disclosure, refers to a blade that is protected from coming into contact with tissue by another structure of the device <NUM>. The handle <NUM>, the first blade <NUM>, and the second blade <NUM> can have any desired size suitable for performing a particular cutting procedure. In addition, the handle <NUM> can be formed of any desired medically acceptable material.

As shown in <FIG> and <FIG>, the tissue cutting device <NUM> can optionally include a housing <NUM>. In embodiments of this nature, the handle <NUM> is coupled to the housing <NUM> and extends outwardly (e.g., from a top end) of the housing <NUM>. The handle <NUM> can be either permanently or removably coupled to the housing <NUM>. Any conventional fastener can be used to couple the handle <NUM> to the housing <NUM>, including but not limited to, screws, glue, or the like. <FIG> and <FIG> show a non-limiting example of an embodiment where the handle <NUM> is screwed to the housing <NUM> via screws inserted into screw holes <NUM>, <NUM>.

In certain cases, the handle <NUM> is positionable within the housing <NUM>. In other embodiments, the handle <NUM> is coupled to an exterior surface (e.g., top surface) of the housing <NUM> and does not extend into any portion of the housing <NUM>. However, a housing <NUM> is not required in all cases, and it is envisioned that the housing <NUM> can be omitted in certain embodiments. In any embodiment of the present disclosure that includes the housing <NUM>, it is preferred that the housing <NUM> has an ergonomic design configured to facilitate holding of the device <NUM>.

Where the housing <NUM> is provided, the housing <NUM> can comprise a single-piece structure. In other instances, the housing <NUM> comprises multiple sections (<FIG>), such as a first section <NUM> and a second section <NUM> that are coupled together. The sections <NUM>, <NUM> of the housing <NUM> can be fixedly or removably coupled together. These sections <NUM>, <NUM> can be coupled together in any conventional manner, such as by screws, snaps, glue or other adhesive. Other types of fasteners not explicitly recited herein can be used to couple together sections of the housing <NUM>, and such alternative fasteners will be readily apparent to skilled artisans.

In some embodiments, an interior surface <NUM> of the housing <NUM> has a recess <NUM> formed therein. As can be appreciated by referring to <FIG>, the recess <NUM> is sized and shaped such that the recess <NUM> is configured to receive the handle <NUM> when the handle <NUM> is coupled to the housing <NUM>. Where the housing <NUM> includes the first section <NUM> and the second section <NUM>, the recess <NUM> is formed in at least one of the first section <NUM> and the second section <NUM> (and optionally, both sections) of the housing <NUM>. In certain other embodiments, the housing <NUM> does not include a recess <NUM>.

In preferred embodiments, the second blade <NUM> and the handle <NUM> are integral structures. In some cases, the handle <NUM>, the first blade <NUM>, and the second blade <NUM> are all integral structures. In still further embodiments, the entire tissue cutting device <NUM> can be a single integral structure so as to define a unibody construction. In such instances, for example, the entire device <NUM> can comprise a single piece of metal (e.g., surgical grade stainless steel), plastic, or any other suitable material. In addition, the tissue cutting device <NUM> can be manufactured by any conventional process. As non-limiting examples, the tissue cutting device <NUM> can be stamped or laser cut.

Advantageously, the second blade <NUM> is rotatable relative to the first blade <NUM> such that the second blade <NUM> is configured to rotate between a first (inactive) position <NUM> (<FIG> and <FIG>) and a second (active) position <NUM> (<FIG>). The second blade <NUM> is in a same plane as the first blade <NUM> when the second blade <NUM> is in the first position <NUM>. This is perhaps best illustrated in <FIG>, which shows that the first blade <NUM> and the second blade <NUM> lie flat (i.e., parallel or substantially parallel) relative to each other when the second blade <NUM> is in the first position <NUM>. This arrangement of the tissue cutting device <NUM> provides a low-profile design that enables the tissue cutting device <NUM> to be inserted into tight spaces underneath a patient's skin, adjacent a desired tissue region.

The second blade <NUM> is rotated into a different plane from the first blade <NUM> as the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>. As described in greater detail below, when the second blade <NUM> is in the first (inactive) position <NUM>, the second blade <NUM> is an unexposed blade that is protected (at least in part) by the first blade <NUM>. The second blade <NUM> can remain in the first position <NUM> until needed for a cutting procedure. Then, when it is desired to cut tissue using the second blade <NUM>, the second blade <NUM> is rotated into the second (active) position <NUM>, thereby becoming an exposed blade.

In certain embodiments, the tissue cutting device <NUM> is hingeless. In such embodiments, as shown in <FIG>, the material properties and design (including the shape of device <NUM>, as well as the thickness and flexibility of the second blade <NUM>) allow the second blade <NUM> to intrinsically bend relative to the first blade <NUM>. The second blade <NUM> should be thin enough to allow the second blade <NUM> to bend to permit its rotation between the first <NUM> and second <NUM> positions. The second blade <NUM> is capable of being bent in a manner that is similar to bending of a paper clip (i.e., whereby twisting an inner portion of a metal paper clip allows the inner portion to be rotated and positioned outside of an outer portion of the paper clip).

In other embodiments, the tissue cutting device <NUM> includes one or more hinges. Any type of conventional mechanical hinge(s) can be used in tissue cutting device <NUM> to allow second blade <NUM> to rotate between its first <NUM> and second <NUM> positions. In other cases, the second blade <NUM> is provided with one or more virtual hinges, such as one or more seams that extend (e.g., longitudinally in series) along a longitudinal axis of the second blade <NUM>. In such instances, the one or more seams extend along the second blade <NUM> at one or more locations where the second blade <NUM> is materially coupled to the first blade <NUM> such that the one or more seams are provided at junction(s) <NUM> of the first blade <NUM> and the second blade <NUM>. The second blade <NUM> can be thinner in the region where the one or more seams are located so as to reduce resistance of the second blade <NUM> to bending. In this manner, the one or more seams facilitate folding and bending of the second blade <NUM> along the second blade's longitudinal axis for rotating the second blade <NUM> from its first position <NUM> toward its second position <NUM>. Thus, the one or more seams allow the second blade <NUM> to move from its first position <NUM> toward its second position <NUM> without separating the first blade <NUM> from the second blade <NUM>.

The second blade <NUM> rotates between the first position <NUM> and the second position <NUM> in response to rotation of the handle <NUM>. Thus, the second blade <NUM> and the handle <NUM> rotate together. The first blade <NUM> is configured to remain stationary or substantially stationary when the second blade <NUM> rotates from the first position <NUM> toward the second position <NUM>. The second blade <NUM> is configured to rotate along its longitudinal axis when the second blade <NUM> rotates between the first position <NUM> and the second position <NUM>. In preferred embodiments, the handle <NUM> is aligned (or substantially aligned) with the longitudinal axis of the second blade <NUM> such that the second blade <NUM> defines a linear extension of the handle <NUM>.

The second blade <NUM> can have any desired degree of rotation as needed to suit a particular cutting procedure. In some instances, the second blade <NUM> is configured to rotate in a range of between <NUM> to <NUM> degrees, including any degree therebetween. In other cases, the second blade <NUM> is configured to rotate in a range of between <NUM> and <NUM> degrees (including any degree therebetween).

The first blade <NUM> is configured to facilitate introduction of the tissue cutting device <NUM> through the dermis and into subcutaneous tissue of a patient. In this manner, the first blade <NUM> eliminates the need for the use of a separate, additional device to introduce the tissue cutting device <NUM> into the skin. Instead, in some embodiments, the tissue cutting device <NUM> has both the first blade <NUM> to introduce the device <NUM> into the skin, and the second blade <NUM> that can be unexposed and protected until needed to cut or release the tissue of interest.

The first blade <NUM> has a distal end <NUM>. In some cases, the outer surface of the first blade <NUM> includes one or more cutting surfaces. In other cases, the distal end <NUM> of the first blade <NUM> defines a tip not intended for cutting tissue. For example, in certain cases, the distal end <NUM> defines a blunt tip (e.g., a rounded, convex end) not intended for cutting tissue. In other cases, the distal end <NUM> defines a sharp-edged tip intended for cutting tissue. For example, in some cases, the distal end <NUM> defines a dissecting tip or a cutting tip. The configuration of the distal end <NUM> of the first blade <NUM> is not particularly limited. For instance, the distal end <NUM> of the first blade <NUM> can include a pointed tip (<FIG>), a curved edge (<FIG> and <FIG>), a straight edge of uniform length, an angled surface that is longer on one side than on the other, or can have any other desired configuration. In addition, the one or more cutting surfaces of the first blade <NUM> (where provided) can extend along the entire outer surface of the first blade <NUM>, along a major length of the outer surface of the first blade <NUM> (i.e., along a length that is greater than <NUM>% of a length of the outer surface), or along only a minor portion of the outer surface of the first blade <NUM>, such as only at the distal end <NUM>.

The second blade <NUM> also has at least one cutting surface <NUM>. In some embodiments, the cutting surface <NUM> of the second blade <NUM> is less sharp than the cutting surface and/or distal end <NUM> of the first blade <NUM>. In other cases, the cutting surface <NUM> of the second blade <NUM> is sharper than some (or all) of the outer surface of the first blade <NUM>. In still yet other cases, the cutting surface <NUM> of the second blade <NUM> has the same sharpness as the outer surface (or as the cutting surface) of the first blade <NUM>.

The configuration of the cutting surface <NUM> of the second blade <NUM> is also not limited. The cutting surface <NUM> can be a single cutting surface or one of many cutting surfaces. Also, the cutting surface <NUM> can be a curved surface, a straight surface (of uniform length), or an angled surface that is longer on one side than on the other side (e.g., a downward-angled cutting surface). In addition, the cutting surface <NUM> can face toward or away from the handle <NUM>, or can face toward either side of the tissue cutting device <NUM>. In some cases, the cutting surface <NUM> is provided on an interior surface of the second blade <NUM>. In other cases, the cutting surface <NUM> is provided on an outer surface of the second blade <NUM> (e.g., so as to provide a superficial cutting surface). In certain embodiments, the cutting surface <NUM> of the second blade <NUM> is a retrograde cutting surface configured to facilitate cutting of tissue when the second blade <NUM> is moved in a retrograde manner. In other cases, the cutting surface <NUM> of the second blade <NUM> is an antegrade cutting surface configured to facilitate cutting of tissue when the second blade <NUM> is moved in an antegrade manner. In yet other cases, the cutting surface <NUM> is both a retrograde and antegrade cutting surface. Skilled artisans will understand that the examples identified herein are not limiting, and that any type of cutting surface can be used as cutting surface <NUM>. Various cutting surfaces <NUM> are shown in the figures. Skilled artisans will appreciate that the cutting surfaces <NUM> shown in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> can be provided in any embodiment of the present disclosure.

Although only one cutting surface <NUM> is shown in the drawings, the second blade <NUM> can have any desired number of cutting surfaces <NUM>, each having any desired configuration. In some cases, the second blade <NUM> is provided with a single cutting surface <NUM>. In other cases, the second blade <NUM> has more than one cutting surface <NUM> to allow the tissue cutting device <NUM> to achieve cuts in multiple directions.

In any embodiment of the present disclosure, the second blade <NUM> is optionally echogenic. In embodiments of this nature, the second blade <NUM> can have a flat superficial surface, etching, or an echogenic coating, with each of these features being designed to improve visualization of the second blade <NUM> under ultrasound.

The tissue cutting device <NUM> further includes a first arm <NUM> and a second arm <NUM>. The first arm <NUM> and the second arm <NUM> define opposite sides of the first blade <NUM>. The first arm <NUM> is coupled to and extends between the first blade <NUM> and a first side <NUM> of the handle <NUM>. In preferred embodiments, the first arm <NUM> is coupled directly to the handle <NUM>. The second arm <NUM> is coupled to the first blade <NUM> and extends from the first blade <NUM> toward a second side <NUM> of the handle <NUM>. However, unlike the first arm <NUM>, the second arm <NUM> does not contact any portion of the handle <NUM> (or the second blade <NUM>). This space between the second arm <NUM> relative to both the handle <NUM> and the second blade <NUM> defines a gap <NUM>. As described in greater detail below, the second arm <NUM> is configured to stabilize the tissue cutting device <NUM> (particularly the first blade <NUM> and the first arm <NUM>) when the second blade <NUM> is rotated from the first position <NUM> to the second position <NUM>. In particular, the gap <NUM> allows only a portion of the tissue cutting device to rotate (i.e., the handle <NUM> and the second blade <NUM>), while a remainder of the device <NUM> is configured to remain stationary or substantially stationary.

When the second blade <NUM> is in the first position <NUM>, the cutting surface <NUM> of the second blade <NUM> is positioned between (e.g., directly between) the handle <NUM> and the first blade <NUM>. In more detail, the second blade <NUM> is located between the handle <NUM>, the first blade <NUM>, the first arm <NUM>, and the second arm <NUM> when the second blade <NUM> is in the first position <NUM>. Thus, the handle <NUM>, the first blade <NUM>, the first arm <NUM>, and the second arm <NUM> define an outer enclosure <NUM> surrounding the second blade <NUM> when the second blade <NUM> is in the first position <NUM>. This outer enclosure <NUM> protects the second blade <NUM> from contacting tissue when the second blade <NUM> is in the first position <NUM>.

The second blade <NUM> is configured to rotate outside of the outer enclosure <NUM> when the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>. Rotation to the second position <NUM> allows the second blade <NUM> to be exposed for cutting tissue, since the second blade <NUM> is no longer protected by the outer enclosure <NUM>. In some cases, as shown in <FIG>, the outer enclosure <NUM> has a convex or substantially convex shape. However, alternative configurations for the outer enclosure <NUM> are also contemplated and within the scope of the present disclosure.

As the second blade <NUM> rotates from the first position <NUM> toward the second position <NUM>, the second arm <NUM> does not rotate (or at least remains stationary or substantially stationary). This is at least in part due to a greater surface area of the second arm <NUM> as compared to a surface area of the second blade <NUM>. In particular, the second blade <NUM> is thin enough to rotate when introduced subcutaneously into the skin near a tissue region of interest. The second arm <NUM>, on the other hand, is held down by the tissue or other structure to be cut and therefore is restrained from rotating when the second blade <NUM> rotates from the first position <NUM> toward the second position <NUM>.

In some cases, at least one tooth <NUM> is coupled to an interior surface <NUM> of at least one of the first arm <NUM> and the second arm <NUM>. In some cases, the at least one tooth <NUM> includes two or more teeth or a plurality of teeth. The at least one tooth <NUM> can be coupled to the only the first arm <NUM>, only the second arm <NUM>, or to both the first arm <NUM> and the second arm <NUM>. The at least one tooth <NUM> is perhaps best shown in <FIG> and <FIG>, where it is depicted as two teeth. The at least one tooth <NUM> is configured to embed into the undersurface of the structure to be cut (e.g., the A1 pulley) to ensure that the device <NUM> will not slide during use. The cutting surface <NUM> of the second blade <NUM> can extend outwardly toward the second arm <NUM> such that the at least one tooth <NUM> is positioned on an arm that is nearest the cutting surface <NUM>.

Another exemplary embodiment of a tissue cutting device <NUM> is shown in <FIG>. Tissue cutting device <NUM> can optionally include any of the features previously described for <FIG>. This embodiment includes a first blade <NUM> and a second blade <NUM> and further includes one or more break points <NUM> between the first blade <NUM> and the second blade <NUM>. The one or more break points <NUM> are configured to be disrupted. The one or more break points <NUM> allow an operator to disrupt the one or more break points <NUM> and separate the first blade <NUM> from the second blade <NUM>. When the one or more break points <NUM> are intact, the second blade <NUM> is its first position <NUM>. When force is applied to each of the one or more break points <NUM> to separate the first blade <NUM> from the second blade <NUM>, the second blade <NUM> assumes its second position <NUM>.

Generally, the first blade <NUM> is coupled to the handle <NUM> via the one or more break points <NUM>, which are configured to break the first blade <NUM> away from the handle <NUM>. The second blade <NUM> is also coupled to the handle <NUM> but does not include any break points. In other words, the second blade <NUM> is configured to remain connected to the handle <NUM> and does not break away from the handle <NUM>. In some cases, the second blade <NUM> is integral to the handle <NUM>. The one or more break points <NUM> allow an operator to break away or separate the first blade <NUM> from the handle <NUM>, thus separating the first blade <NUM> from the second blade <NUM> and the handle <NUM>. In certain cases, the one or more break points <NUM> are configured to be disrupted when the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>.

Referring to <FIG>, certain embodiments include a first blade <NUM> that includes a distal end <NUM> and a proximal end <NUM>. The first blade <NUM> extends for a length "X" along its longitudinal axis from the distal end <NUM> to the proximal end <NUM>. The first blade <NUM> also includes a first arm <NUM> and a second arm <NUM>. The first arm <NUM> and the second arm <NUM> define opposite sides of the first blade <NUM>. Each the first arm <NUM> and the second arm <NUM> extend along the longitudinal axis between the distal end <NUM> and a proximal end <NUM>.

The first arm <NUM> is coupled to the handle <NUM> at the one or more break points <NUM>. The second arm <NUM> is not coupled to the handle <NUM>. Rather, the second arm <NUM> does not contact any portion of the handle <NUM>. A gap <NUM> is provided between the second arm <NUM> and the handle <NUM>. The one or more break points <NUM> can be provided anywhere along the first arm <NUM>. In certain cases, the one or more break points <NUM> are positioned on the first arm <NUM> such that the one or more break points <NUM> are adjacent to the proximal end <NUM>.

The one or more break points <NUM> are configured to break the first arm <NUM> from the handle <NUM> upon force. In other words, an operator applies force to the one or more break points <NUM> to disrupt them and therefore separate the first arm <NUM> (and thus the first blade <NUM>) from the handle <NUM> (and thus the second blade <NUM>). The one or more break points <NUM> can include any mechanism that allows force to break away the first arm <NUM> from the handle <NUM>. In certain cases, each of the one or more break points <NUM> is formed as a break-away seam. In other cases, each of the one or more break points <NUM> is formed as a break-away hinge. Such break-away seams or hinges can include snap perforations or frangible bridges that allow force to break away the first arm <NUM> from the handle <NUM>.

In certain embodiments, an operator uses rotational force to break away the first arm <NUM> from the handle <NUM>. For example, an operator rotates the handle <NUM> in either a clockwise or counterclockwise direction to disrupt the one or more break points <NUM>. In other embodiments, an operator uses shear force (e.g., a pushing or pulling force). Any number of break away mechanisms are contemplated.

Some embodiments also provide one or more flanges that extend outward from the first blade <NUM>. The one or more flanges are sized and shaped to accommodate an operator's fingers. An operator can grasp the one or more flanges to assist in manipulating the first blade <NUM>. In certain cases, the one or more flanges extend radially outward from the longitudinal axis of the first blade <NUM>. In some cases, the one or more flanges extend generally perpendicular from the longitudinal axis of the first blade <NUM>. In some cases, the one or more flanges are provided as a first flange and a second flange. The first flange and second flange can extend outward as a pair of wings, similar to flanges of a medical syringe. In other cases, the one or more flanges are provided as a single circular flange that surrounds the first blade <NUM>. A variety of different types of flanges are contemplated.

In the embodiment of <FIG>, the first blade <NUM> includes a first flange <NUM> and a second flange <NUM>. The first flange <NUM> extends from the first arm <NUM> and the second flange <NUM> extends from the second arm <NUM>. Also, the first flange <NUM> extends radially outward from the first arm <NUM> and from the longitudinal axis of the first blade <NUM>, and the second flange <NUM> extends radially outward from the second arm <NUM> and from the longitudinal axis of the first blade <NUM>. In some cases, the first flange <NUM> and the second flange <NUM> can each extend generally perpendicular to the longitudinal axis, although this is not required.

As shown in <FIG>, both the first flange <NUM> and the second flange <NUM> are positioned near a proximal end <NUM> of the first blade <NUM>. The first blade <NUM> is also provided with a length "X," which is the length between the distal end <NUM> and the proximal end <NUM>. The length "X" is selected to be a maximum length of where the first blade <NUM> should be inserted into the body. The first flange <NUM> and the second flange <NUM> therefore prevent the first blade <NUM> from being inserted beyond the selected maximum length and therefore prevent it from being inserted too deeply into the body. The flanges <NUM>, <NUM> also allow manipulation and stabilization of the whole device (including the handle <NUM>, first blade <NUM> and second blade <NUM>) before separation of the first blade <NUM> from the handle <NUM>.

Once the first blade <NUM> is separated from the handle <NUM>, an operator can move the second blade <NUM> independently of the first blade <NUM>. In some cases, an operator can rotate the second blade <NUM> in a range of between <NUM> to <NUM> degrees. Any desired movement is possible since the second blade <NUM> is independent of the first blade <NUM>. An operator then uses the handle <NUM> to manipulate the second blade <NUM> to perform the desired cutting. Once cutting is completed, the operator pulls the handle <NUM> and thus the second blade <NUM> out of the body. The flanges <NUM>, <NUM> also allow manipulation and stabilization of the first blade <NUM> after separation from the second blade <NUM>. For example, an operator can grasp the flanges <NUM>, <NUM> with fingers and pull the first blade <NUM> out of the body.

One or more grip-enhancing features <NUM> can optionally be provided for any tissue cutting device of the present disclosure. The grip-enhancing feature(s) <NUM> are configured to improve the operator's ability to grip the tissue cutting device. In some cases, the one or more grip-enhancing features <NUM> are provided on the handle <NUM> and/or the flange(s) <NUM>, <NUM>. In some cases, the one or more grip-enhancing features <NUM> comprise etching, texture, and/or marking indicia (e.g., logos, text, etc.). These examples, however, are by no means limiting, and skilled artisans will appreciate that any grip-enhancing features can be used. In the embodiments shown in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the one or more grip-enhancing features <NUM> comprise text (e.g., letters) on the handle <NUM>.

In certain embodiments, the first blade <NUM> comprises a lip <NUM>. When the second blade <NUM> is in the first position <NUM>, the lip <NUM> is configured to surround the cutting surface <NUM> of the second blade <NUM> such that the cutting surface <NUM> of the second blade <NUM> rests upon the lip <NUM>. In this manner, the lip <NUM> is configured to keep the cutting surface <NUM> of the second blade <NUM> from being deflected out of plane with respect to the first blade <NUM> while the second blade <NUM> is not intended to be used for cutting. Although the lip <NUM> is shown only in <FIG>, such a lip can be provided in any embodiment of the present disclosure.

Although certain embodiments describing one or more break points <NUM> have been described, in some cases, the one or more break points <NUM> are omitted and replaced with one or more hinges. In such cases, the one or more hinges are provided in location(s) where the one or more break points <NUM> would otherwise be located. In such instances, the one or more hinges enable the second blade <NUM> to rotate relative to the first blade <NUM>, but does not allow the first blade <NUM> to be separated from the second blade <NUM>. In other words, the first blade <NUM> is configured to remain connected to the handle <NUM> and does not break away from the handle <NUM> (such that the first blade <NUM> and the second blade <NUM> also remain connected). In embodiments of this nature, any type of conventional mechanical hinge(s) can be used to allow second blade <NUM> to rotate between its first <NUM> and second <NUM> positions. In other cases, one or more virtual hinges, such as one or more seams, are provided. In such instances, the one or more virtual hinges (e.g., the one or more seams) extend along the first blade <NUM> at one or more locations where the first blade <NUM> is materially coupled to the handle <NUM>. In embodiments where one or more hinges are provided, the second blade <NUM> is able to rotate relative to the first blade <NUM> in a similar manner to the other hinge embodiments described herein (e.g. by rotating the handle <NUM>).

The present disclosure also provides tissue cutting device <NUM>, shown in <FIG>. As with tissue cutting device <NUM>, tissue cutting device <NUM> can be used to cut any desired soft tissue structure in the body (e.g., of a human or non-human mammal). Such soft tissue structure includes but is not limited to, a ligament, fascia, or tendon. In certain embodiments, the tissue cutting device <NUM> is used to cut an A1 pulley.

Similar to cutting device <NUM>, cutting device <NUM> has a handle <NUM>, a first blade <NUM>, and a second blade <NUM>. The first blade <NUM> extends away from the handle <NUM>. The second blade <NUM> is coupled to and extends outwardly from the handle <NUM>. In some cases, the second blade <NUM> is screwed to the handle <NUM>. For example, as shown in <FIG> and <FIG>, the handle <NUM> and the second blade <NUM> can have screw holes <NUM>, <NUM> formed therein for connecting the second blade <NUM> to the handle <NUM>. However, it will be appreciated that any conventional fastener, including but not limited to, screws, glue or other adhesive, can be used to couple the second blade <NUM> to the handle <NUM>. Furthermore, the handle <NUM> preferably has an ergonomic design configured to facilitate holding of the device <NUM>.

Similar to cutting device <NUM>, the handle <NUM>, the first blade <NUM>, and the second blade <NUM> of cutting device <NUM> can have any desired size suitable for performing a particular cutting procedure. In addition, the handle <NUM> can be formed of any desired medically acceptable material.

The first blade <NUM> is similar to the first blade <NUM> of device <NUM>. In particular, the first blade <NUM> is configured to facilitate introduction of the tissue cutting device <NUM> through the dermis and into subcutaneous tissue of a patient. In this manner, the first blade <NUM> eliminates the need for the use of a separate, additional device to introduce the tissue cutting device <NUM> into the skin. Instead, in some embodiments, the tissue cutting device <NUM> has both the first blade <NUM> to introduce the device <NUM> into the skin, and the second blade <NUM> that can be unexposed and protected until needed to cut or release the tissue of interest.

The first blade <NUM> has a shaft <NUM>. The shaft <NUM> includes a distal end <NUM> provided on an outer surface of the first blade <NUM>. In some cases, the distal end <NUM> of the first blade <NUM> includes one or more cutting surfaces. In other cases, the distal end <NUM> of the first blade <NUM> defines a blunt tip that is not intended for cutting tissue. The configuration of the distal end <NUM> of the first blade <NUM> is not particularly limited. For instance, the distal end <NUM> of the first blade <NUM> can include a pointed tip, a curved edge, a straight edge of uniform length, an angled surface that is longer on one side than on the other, or can have any other desired configuration. In addition, the one or more cutting surfaces of the first blade <NUM> can extend along the entire outer surface of the first blade <NUM>, along a major length of the outer surface (i.e., greater than <NUM>% of a length of the outer surface) of the first blade <NUM>, or along only a minor portion of the outer surface of the first blade <NUM>, such as only at the distal end <NUM> of the outer surface of the first blade <NUM>.

The second blade <NUM> of device <NUM> is similar to the second blade <NUM> of device <NUM> and has a cutting surface <NUM>. In some embodiments, the cutting surface <NUM> of the second blade <NUM> is less sharp than the cutting surface and/or distal end <NUM> of the first blade <NUM>. In other cases, the cutting surface <NUM> of the second blade <NUM> is sharper than some (or all) of outer surface of the first blade <NUM>. In still yet other cases, the cutting surface <NUM> of the second blade <NUM> has the same sharpness as the outer surface (or as the cutting surface) of the first blade <NUM>.

The configuration of the cutting surface <NUM> of the second blade <NUM> is also not limited. As shown, the cutting surface <NUM> can be a curved surface, a straight surface (or uniform length), an angled surface that is longer on one side than on the other side (e.g., a downward-angled cutting surface). In addition, the cutting surface <NUM> can face toward or away from the handle <NUM>, or can face toward either side of the tissue cutting device <NUM>. In some cases, the cutting surface <NUM> is provided on an interior surface of the second blade <NUM>. In other cases, the cutting surface <NUM> is provided on an outer surface of the second blade <NUM> (e.g., so as to provide a superficial cutting surface). In certain embodiments, the cutting surface <NUM> of the second blade <NUM> is a retrograde cutting surface configured to facilitate cutting of tissue when the second blade <NUM> is moved in a retrograde manner. In other cases, the cutting surface <NUM> of the second blade <NUM> is an antegrade cutting surface configured to facilitate cutting of tissue when the second blade <NUM> is moved in an antegrade manner. Skilled artisans will understand that the examples identified herein are not limiting, and that any type of cutting surface can be used as cutting surface <NUM>.

The second blade <NUM> is rotatable relative to the first blade <NUM> such that the second blade <NUM> is configured to rotate between a first (inactive) position <NUM> (<FIG>, <FIG>, and <FIG>) and a second (active) position <NUM> (<FIG> and <FIG>). The second blade <NUM> is in a same plane as the first blade <NUM> when the second blade <NUM> is in the first position <NUM>. The second blade <NUM> is in a different plane from the first blade <NUM> when the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>. This can be appreciated by comparing <FIG> with <FIG>.

<FIG>, <FIG> and <FIG> show that both the first blade <NUM> and the second blade <NUM> lie flat (i.e., parallel or substantially parallel) relative to each other when the second blade <NUM> is in the first position <NUM>. This arrangement of the tissue cutting device <NUM> provides a low-profile design that enables the tissue cutting device <NUM> to be inserted into tight spaces underneath a patient's skin, adjacent a desired tissue region.

The second blade <NUM> is rotated into a different plane from the first blade <NUM> as the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>. As described in greater detail below, when the second blade <NUM> is in the first (inactive) position <NUM>, the second blade <NUM> is an unexposed blade that is protected from contacting tissue. The second blade <NUM> can remain in the first position <NUM> until needed for a cutting procedure. Then, when it is desired to cut tissue using the second blade <NUM>, the second blade <NUM> is rotated into the second (active) position <NUM>, thereby becoming an exposed blade.

In preferred embodiments, the first blade <NUM> is in contact (e.g., direct physical contact) with the second blade <NUM> when the second blade <NUM> is in the first position <NUM>. This configuration is shown schematically in <FIG>. In some cases, the shaft <NUM> of the first blade <NUM> has a recessed area (not shown) in an upper surface <NUM> thereof configured to receive the shaft <NUM> of the second blade <NUM>. This arrangement allows the second blade <NUM> to be recessed into the first blade <NUM>. The depth of the recessed area in the shaft <NUM> of the first blade <NUM> is variable such that the extent to which the first blade <NUM> is recessed into the second blade <NUM> is also variable. The recessed area in the shaft <NUM> of the first blade <NUM> can be an imprint formed in any conventional manner, e.g., by stamping. In certain embodiments, the first blade <NUM> is entirely recessed within the second blade <NUM> when the second blade <NUM> is in the first position <NUM>. In such cases, when the second blade <NUM> is rotated from the first position <NUM> toward the second position <NUM>, at least a portion of the second blade <NUM> rotates out of the recessed area of the first blade <NUM>. In other cases, the shaft <NUM> of the first blade <NUM> does not include a recessed area. Instead, the second blade <NUM> is positioned so as to lie on top of, and directly contact, the upper surface <NUM> of the first blade <NUM>.

In still yet other cases, the first blade <NUM> and the second blade <NUM> are not in direct contact when the second blade <NUM> is in the first position <NUM> such that a gap is formed between the first <NUM> and second <NUM> blades. However, since tissue may become trapped within the gap, it is preferable that the gap (where present) be as small as possible.

In certain embodiments, the tissue cutting device <NUM> is hingeless. In such embodiments, as shown in <FIG>, the material properties and design (including the shape of device <NUM>, as well as the thickness and flexibility of the second blade <NUM>) allow the second blade <NUM> to intrinsically bend relative to the first blade <NUM>. This optional hingeless feature of device <NUM> is similar to certain hingeless embodiments of device <NUM>.

In other embodiments, the tissue cutting device <NUM> includes one or more hinges. Any type of conventional mechanical hinge(s) can be used in tissue cutting device <NUM> to allow second blade <NUM> to rotate between its first <NUM> and second <NUM> positions. In other cases, the second blade <NUM> is provided with one or more virtual hinges, such as one or more seams that extend (e.g., longitudinally in series) along a longitudinal axis of the second blade <NUM>. In such instances, the one or more seams extend along the second blade <NUM> at location(s) where the second blade <NUM> is materially coupled to the first blade <NUM> such that the one or more seams are provided at junction(s) of the first blade <NUM> and the second blade <NUM>. The second blade <NUM> can be thinner in the region where the one or more seams are located so as to reduce resistance of the second blade <NUM> to bending. In this manner, the one or more seams facilitate folding and bending of the second blade <NUM> along the second blade's longitudinal axis for rotating the second blade <NUM> from its first position <NUM> toward its second position <NUM>.

The second blade <NUM> rotates between the first position <NUM> and the second position <NUM> in response to rotation of the handle <NUM>. Thus, the second blade <NUM> and the handle <NUM> rotate together. The first blade <NUM> is configured to remain stationary or substantially stationary when the second blade <NUM> rotates from the first position <NUM> toward the second position <NUM>. The second blade <NUM> is configured to rotate along its longitudinal axis when the second blade <NUM> rotates between the first position <NUM> and the second position <NUM>.

The second blade <NUM> can have any desired degree of rotation as needed to suit a particular cutting procedure. In some instances, the second blade <NUM> is configured to rotate in a range of between <NUM> and <NUM> degrees, including any degree therebetween. In other cases, the second blade <NUM> is configured to rotate in a range of between <NUM> and <NUM> degrees, including any degree therebetween. In still other cases, the second blade <NUM> is configured to rotate in a range of between <NUM> and <NUM> degrees, including any degree therebetween. In certain embodiments, the degree of rotation of the second blade <NUM> can be adjustable. Such adjustability can advantageously help account for anatomic variations between patients.

The handle <NUM> defines a housing having an interior surface <NUM>. In some cases, the handle <NUM> comprises a single-piece structure. In other instances, the handle <NUM> comprises multiple sections, such as a first section <NUM> and a second section <NUM> that are coupled (e.g., molded) together. In some embodiments, the interior surface <NUM> of the handle <NUM> has a recess <NUM> formed therein. The recess <NUM> is sized and shaped such that the recess <NUM> is configured to receive a shaft <NUM> of the second blade <NUM>. Where the handle <NUM> includes the first section <NUM> and the second section <NUM>, the recess <NUM> is formed in at least one of the first section <NUM> and the second section <NUM> (and in some cases, both sections) of the handle <NUM>. The coupling of the second blade <NUM> and the handle <NUM> ensures that the handle <NUM> and the second blade <NUM> rotate together.

The handle <NUM> has an interior <NUM>. In some cases, the interior <NUM> of the handle <NUM> includes vertical side walls <NUM> and a medial wall <NUM> coupled to and extending horizontally between at least two of the vertical side walls <NUM>. The vertical side walls <NUM> and the medial wall <NUM> define a chamber <NUM> within the interior <NUM> of the handle <NUM>.

In certain embodiments, the tissue cutting device <NUM> further comprises a lock <NUM> (<FIG>, <FIG>, and <FIG>). The lock <NUM> has a locked configuration and an unlocked configuration. When the lock <NUM> is in the unlocked configuration, the second blade <NUM> is rotatable from the first position <NUM> toward the second position <NUM>. When the lock <NUM> is in the locked configuration, the lock <NUM> is configured to restrain the second blade <NUM> from rotating relative to the first blade <NUM>. The second blade <NUM> is locked in the first position <NUM> when the lock <NUM> is in the locked configuration.

The tissue cutting device <NUM> also includes a cover <NUM>. The cover <NUM> is coupled to an upper end <NUM> of the handle <NUM>. The handle <NUM> is rotatable relative to the cover <NUM> to permit the second blade <NUM> to rotate from the first position <NUM> toward the second position <NUM>. In embodiments that include the lock <NUM>, the handle <NUM> is rotatable relative to the cover <NUM> when the lock <NUM> is in the unlocked configuration, whereas the handle <NUM> is restrained from rotating relative to the cover <NUM> when the lock <NUM> is in the locked configuration.

In certain embodiments, the cover <NUM> has a notch <NUM> formed therein (e.g., in a side surface thereof). The lock <NUM> is received in the notch <NUM> when the lock <NUM> is in the locked configuration. Then, the lock <NUM> can be disengaged from the notch <NUM> when the operator desires to cut a desired tissue. This in turn disengages the cover <NUM> from the handle <NUM> and allows the handle <NUM> to rotate relative to the cover <NUM>. In some cases, the cover <NUM> and the handle <NUM> are connected via snap fit notches that allow free rotation of the handle <NUM> relative to the cover <NUM> when the lock <NUM> is in the unlocked configuration.

In certain embodiments (not shown), the cover <NUM> includes more than one notch <NUM>. The cover <NUM> can include any desired number of notches <NUM>. Multiple notches <NUM> allow the operator to control axial rotation of the second blade <NUM> within a specified range (i.e., between adjacent notches <NUM>) that is dictated by the notches <NUM>. For example, the cover <NUM> can include four notches <NUM>, each spaced equally apart about a perimeter of the cover <NUM>. In this non-limiting example, by rotating the second blade <NUM> between one or more adjacently positioned notches <NUM>, the operator is able to lock the second blade <NUM> in place after rotating the second blade <NUM> exactly <NUM> degrees, exactly <NUM> degrees, exactly <NUM> degrees, or exactly <NUM> degrees.

A top end <NUM> of the cover <NUM> has both a first opening <NUM> and a second opening <NUM> formed therein. The first opening <NUM> is configured to receive the first blade <NUM>. The second opening <NUM> is configured to receive the second blade <NUM>. In certain preferred embodiments, the first blade <NUM> is mounted within a slot defined by the first opening <NUM>. In some cases, the first blade <NUM> is glued within the slot. This, however, is by no means required. For instance, the first blade <NUM> can be mounted in the slot of the first opening <NUM> in any conventional manner.

In preferred embodiments, the first opening <NUM> is laterally offset from the second opening <NUM> so as to arrange the blades <NUM>, <NUM> in an L-shaped configuration. This arrangement, which is shown in <FIG>, helps prevent the entrapment of tissue, and allows the second blade <NUM> to rotate without interference from the first blade <NUM>. In other cases, the first opening <NUM> is centered between opposite sides of the cover <NUM>, such that the first <NUM> and second <NUM> blades are arranged in a T-shaped configuration.

The tissue cutting device <NUM> also includes a biasing member <NUM>. The biasing member <NUM> is positionable within the interior <NUM> of the handle <NUM>, particularly within the chamber <NUM>. In certain embodiments, the biasing member <NUM> is operably coupled to the lock <NUM> so as to resiliently bias the lock <NUM> into the locked configuration. In other cases (e.g., in embodiments where there is no lock <NUM>), the biasing member <NUM> merely biases the handle <NUM> toward the cover <NUM>. In some embodiments, as shown in <FIG>, <FIG>, and <FIG>, the biasing member <NUM> is a spring.

Certain embodiments of the tissue cutting device <NUM> further include a projection <NUM>. The projection <NUM> is attached to the lock <NUM>. The projection <NUM> is also positionable within the interior <NUM> of the handle <NUM>, particularly within the chamber <NUM>. When in an uncompressed state, the biasing member <NUM> is configured to urge against the projection <NUM> so as to provide upward force to the lock <NUM> to retain the lock <NUM> in the locked configuration. The projection <NUM> is also configured to apply a counterforce to the biasing member <NUM> (so as to compress the biasing member <NUM>) when the lock <NUM> is moved from the locked configuration to the unlocked configuration. In preferred cases, the lock <NUM> (whether in the locked or unlocked configuration) is positioned nearer to the cover <NUM> than is the projection <NUM>.

In some embodiments, the tissue cutting device <NUM> includes an actuator <NUM>. The actuator <NUM> is coupled to the lock <NUM> and is configured to move the lock <NUM> between the locked and unlocked configurations. In certain embodiments, the handle <NUM> has a slot <NUM> formed in an outer surface <NUM> thereof. The actuator <NUM> is slidably mounted in the slot <NUM> and is movable between a first position and a second position (e.g., using the operator's thumb or other finger). Slidable movement of the actuator <NUM> between its first and second positions causes the lock <NUM> to move between its locked and unlocked configurations. In more detail, when the actuator <NUM> is in the first position, the lock <NUM> is in the locked configuration. When the actuator <NUM> is in the second position, the lock <NUM> is in the unlocked configuration. When the lock <NUM> is received in the notch <NUM> of the cover <NUM>, the notch <NUM> is aligned with the slot <NUM>.

In certain embodiments, the lock <NUM> is positioned between the projection <NUM> and the actuator <NUM>. However, in alternative embodiments, the lock <NUM> and the projection <NUM> can be vertically aligned with respect to each other and each coupled to the actuator <NUM>.

In certain embodiments, to use tissue cutting device <NUM>, the operator pulls the actuator <NUM> toward a bottom end <NUM> of the handle <NUM> (i.e., a proximal end of the device <NUM>). This in turn causes the lock <NUM> to be pulled away from (and out of) the notch <NUM>. Thus, the actuator <NUM> can be pulled to disengage the lock <NUM>, thus allowing the second blade <NUM> to rotate from the first position <NUM> toward the second position <NUM>.

An outer surface <NUM> of the actuator <NUM> can optionally comprise a material, or include surface features, configured to facilitate gripping of the actuator <NUM>. For instance, in some embodiments, the outer surface <NUM> of the actuator <NUM> comprises rubber or another suitable gripping material. In addition or alternatively, the outer surface <NUM> of the actuator <NUM> can include surface features, such as textured ridges, to facilitate sliding of the actuator <NUM> between its first and second positions.

In alternative embodiments, the cover <NUM> is devoid of an actuator <NUM> and notches <NUM>, and instead is merely activated by friction. In such cases, the tissue cutting device <NUM> can include at least one tooth (e.g., a plurality of teeth) or any high-friction surface (e.g., rubber). The teeth or high friction surface of device <NUM> are configured to restrain the handle <NUM> from rotating relative to the cover <NUM> such that the handle <NUM>, when rotated, can be locked into any position along a <NUM>-degree arc about the cover <NUM>. The teeth (or high-friction surface) can be provided on the cover <NUM>, on the handle <NUM>, or on both the handle <NUM> and the cover <NUM>. Where the teeth (or high-friction surface) are provided on the cover <NUM>, the handle <NUM> is restrained from rotating relative to the cover <NUM> when the teeth (or high-friction surface) are in contact with an adjacent surface of the handle <NUM>. Where the teeth (or high-friction surface) are provided on the handle <NUM>, the handle <NUM> is restrained from rotating relative to the cover <NUM> when the teeth (or high-friction surface) are in contact with an adjacent surface of the cover <NUM>. In use, the handle <NUM> is pulled away from the cover <NUM> to compress the biasing member <NUM>. The handle <NUM> can then be rotated any desired degree relative to the cover <NUM> to rotate the second blade <NUM> any desired degree from the first position <NUM> toward the second position <NUM>.

The dimensions of tissue cutting device <NUM>, tissue cutting device <NUM>, and tissue cutting device <NUM> are not limited to the particular dimensions shown, but instead, can have any dimensions needed to suit a particular cutting procedure. For instance, a width and/or length of the first blade <NUM>, <NUM>, the second blade <NUM>, <NUM>, the handle <NUM>, <NUM>, and/or the housing <NUM> can be varied as desired.

The present disclosure also provides a method of using the cutting devices <NUM>, <NUM>, <NUM> to cut the soft tissue (e.g., ligament, fascia, or tendon) of a patient. In certain embodiments, the present disclosure provides a method of performing an A1 pulley release procedure to treat trigger finger. However, it should be understood that the present methods can be used to cut any soft tissue structure.

Generally, the method of the present disclosure includes the steps of (a) providing a soft tissue cutting device <NUM>, <NUM>, <NUM>; (b) advancing the tissue cutting device <NUM>, <NUM>, <NUM> to a body region; (c) rotating the second blade <NUM>, <NUM> from the first position <NUM>, <NUM> to the second position <NUM>, <NUM>; and (d) cutting soft tissue in the body region using the second blade <NUM>, <NUM> when the second blade <NUM>, <NUM> is in the second position <NUM>, <NUM>. Unless stated otherwise, for any method of the present disclosure, any of tissue cutting devices <NUM>, <NUM>, or <NUM> can be used. As described below, the step of advancing the tissue cutting device <NUM>, <NUM>, <NUM> to the body region involves using the first blade <NUM>, <NUM> to introduce the tissue cutting device <NUM>, <NUM>, <NUM> into the body region.

In preferred embodiments, the method includes applying anesthetic to the patient's skin. Thereafter, the device <NUM>, <NUM>, <NUM> is placed through and into the patient's skin adjacent a desired tissue plane. In some cases, the device <NUM>, <NUM>, <NUM> is placed deep to the desired tissue plane such that the tissue to be cut is positioned above the cutting device <NUM>, <NUM>, <NUM>. However, the exact positioning of the device <NUM>, <NUM>, <NUM> will depend on the configuration of the first blade <NUM>, <NUM> and the second blade <NUM>, <NUM>, as well as on the type of cutting procedure to be performed.

For the methods of the present disclosure, a small incision is made in the patient's skin. In some cases, this incision can be made by using the first blade <NUM>, <NUM> where the outer surface of the first blade <NUM>, <NUM> includes a cutting blade. In other cases, particularly where the outer surface of the first blade <NUM>, <NUM> is a blunt end, a separate device (i.e., a device other than device <NUM>, <NUM>, or <NUM>) is used to make the incision.

The first blade <NUM>, <NUM> is then placed into subcutaneous tissue of the patient such that the outer surface of the first blade <NUM>, <NUM> is adjacent a desired tissue plane. Preferably, this placement is performed under ultrasound guidance. During the insertion and initial placement of the device <NUM>, <NUM>, <NUM> into the patient's body, the second blade <NUM>, <NUM> remains in the first position <NUM>, <NUM>. Then, when it is desired to cut the tissue, the handle <NUM>, <NUM> can be rotated to cause the second blade <NUM>, <NUM> to rotate from its first position <NUM>, <NUM> toward its second position <NUM>, <NUM> so as to become an exposed blade. A cutting surface <NUM>, <NUM> of the second blade <NUM>, <NUM> is then used to cut the tissue in a customary manner. As discussed above, the manner of cutting using the second blade <NUM>, <NUM> will vary depending on the particular type of cutting surface <NUM>, <NUM>, and its location on the second blade <NUM>, <NUM>. For example, the second blade <NUM>, <NUM> may need to be pushed or pulled to cut the tissue. Once the tissue is cut, the device <NUM>, <NUM>, <NUM> is pulled out of the incision to complete the surgical procedure. The device <NUM>, <NUM>, <NUM> can optionally be discarded after use.

Use of embodiments of the device <NUM> shown in <FIG> may include steps in addition to those noted above. For example, when inserting the device <NUM>, the flanges <NUM>, <NUM> help prevent the operator from inserting the device <NUM> too far into the body region. Once the device <NUM> is positioned, an operator can apply rotational force to the second blade <NUM> (for example, by rotating the handle <NUM>) to cause the one or more break points <NUM> to disrupt, thereby separating the first blade <NUM> from the second blade <NUM>. In certain embodiments, the operator can apply shear force (e.g., by pulling or pushing) the handle <NUM> to cause the one or more break points <NUM> to disrupt, thereby separating the first blade <NUM> from the second blade <NUM>. The first blade <NUM> and the second blade <NUM> thereby become separate devices. The operator can then freely move and rotate the second blade <NUM> to perform cutting. After cutting, the operator can grasp the handle <NUM> and pull the second blade <NUM> to remove it from the body region. The first blade <NUM> can remain in the body until after the second blade <NUM> is removed. The operator can then grasp the flanges <NUM>, <NUM> of the first blade <NUM> with fingers and then pull the first blade <NUM> to remove it from the body region.

Due to the presence of actuator <NUM> in certain embodiments of device <NUM>, use of device <NUM> may include steps in addition to those noted above. In particular, once the positioning of device <NUM> is confirmed (e.g., under ultrasound), the operator can slide the actuator <NUM> from the first position to the second position to disengage the lock <NUM> from the notch <NUM>. The operator then rotates the handle <NUM> to rotate the second blade <NUM> from the first position <NUM> toward the second position <NUM>. Cutting of the tissue of interest (e.g., the A1 pulley) can then be performed by moving the second blade <NUM> in a conventional manner against the tissue. For embodiments that do not include the actuator <NUM> or notch(es) <NUM>, the handle <NUM> is merely pulled away from the cover <NUM> to compress the biasing member <NUM>, and the handle <NUM> is then rotated any desired degree relative to the cover <NUM>.

In some cases, the method is an A1 pulley release procedure for treating trigger finger. In such cases, the distal end <NUM>, <NUM> of the first blade <NUM>, <NUM> is placed deep to (i.e., below) the A1 pulley and superficial to (i.e., above) the flexor tendon group. The device <NUM>, <NUM>, <NUM> is initially flat (i.e., parallel to the patient's hand) and placed distal to proximal to the A1 pulley such that the distal end <NUM>, <NUM> of the first blade <NUM>, <NUM> faces toward the patient's wrist. In such cases, the device <NUM>, <NUM>, <NUM> is properly positioned when the first blade <NUM>, <NUM> is located above the tendon, the second blade <NUM>, <NUM> is located above the first blade <NUM>, <NUM> and below the A1 pulley, and the patient's skin is located above the A1 pulley. Thereafter, the handle <NUM>, <NUM> is rotated so as to rotate the second blade <NUM>, <NUM> from its first position <NUM>, <NUM> toward its second position <NUM>, <NUM>. This rotation exposes the second blade <NUM>, <NUM> to the A1 pulley. The second blade <NUM>, <NUM> is then used to cut the A1 pulley, for example, by moving the second blade <NUM>, <NUM> in a retrograde manner (i.e., proximal to distal) against the A1 pulley.

For the above-described methods, and with respect to devices <NUM> and <NUM> in particular, upward force from the tendon, as well as a counterforce from the A1 pulley, help keep the second arm <NUM> parallel to the plane of the A1 pulley while the second blade <NUM> rotates from the first position <NUM> to the second position <NUM>.

While tissue cutting devices <NUM>, <NUM>, and <NUM> have been described as having first and second blades, skilled artisans will appreciate that alternative cutting mechanisms can be used. For example, in some embodiments, the first blade, second blade, or both can be replaced with a cutting mechanism configured to use electricity, heat, radiofrequency, or laser to cut soft tissue. Except for the type of cutting mechanism, such tissue cutting devices are otherwise the same as those that have been described above and can generally be used in a similar manner.

Claim 1:
A tissue cutting device comprising:
a handle (<NUM>);
a first blade (<NUM>);
a second blade (<NUM>) blade rotatable relative to the first blade, the second blade being in a same plane as the first blade when the second blade is in the first position, the second blade being rotated into a different plane from the first blade as the second blade is rotated from the first position toward the second position; and
one or more break points (<NUM>) positioned between the first blade and the second blade, the one or more break points being configured to be disrupted when the second blade is rotated from the first position toward the second position;
wherein when the one or more break points are intact, the first blade is connected to the second blade, and wherein when each of the one or more break points is disrupted, the first blade is separated from the second blade.