Patent Description:
Certain skin conditions, such as boils, can be treated by making an incision. While this can be accomplished using a surgical blade, this method of treatment assumes a patient that is at ease with the procedure. Some patients, for example pediatric patients, suffering from said skin conditions are more likely to react negatively to seeing a surgical blade. Reactions may include increased anxiety and fear to the extent that the patient may be uncooperative and attempt to refuse treatment.

Furthermore, and with respect to boils, for example, boils are frequently under pressure such that should the boil be pierced (via an initial incision), pus or other purulent material within the boil could "explode," such as to eject said pus or other purulent material, including infectious organisms, onto the medical personnel using a surgical blade to open the boil. This causes a great risk of pus or other purulent material contacting open orifices of the medical personnel or the patient, such as the eyes, nose, mouth, and/or skin.

Existing devices include spring assisted lancets that have some ability to enclose the incision site. For example, <CIT>) and <CIT>) both teach lancets which are pressed against the skin during use.

Therefore, there is a need for a device that can introduce a precise incision without adding anxiety to the procedure, and that can also protect the user of the device from coming into contact with the pus or other purulent material. Further desired benefits may include the simplification of the procedure while keeping the procedure fast and accurate.

The invention provides a device according to claim <NUM>. Further embodiments of the invention are provided in the dependent claims.

The present disclosure includes embodiments of a sheathed cutting device that can prevent patients from observing the incision procedure. Additionally, the device is able to introduce quick and accurate incisions without introducing anxiety or fear.

In an exemplary embodiment of a device for a sheathed cutting device of the present disclosure, the device comprises a body having a proximal and distal end, a cutting member attached to a plunger, both housed at least partially within the body; a biasing member configured to bias the cutting member to an initial position wherein the cutting member is fully within the body; and wherein the plunger is slidable into the proximal end of the body and the cutting member is extendable from the distal end of the body.

In another embodiment, the biasing member is disposed around the plunger. In a further embodiment, the biasing member is connected to the plunger at a first end and to the body at a second end. In another embodiment, the biasing member is disposed within the body. In another embodiment, the biasing member is disposed external to the body.

In another embodiment, the cutting member is a blade or a plurality of needles.

In another embodiment, the device further comprises a depth adjustment member.

In another embodiment, a device for discreetly piercing a skin of a patient, the device comprises a body having a proximal and distal end, a cutting member attached to a plunger, both housed at least partially within the body; a biasing member configured to bias the cutting member to an initial position wherein the cutting member is fully within the body; a cup portion on the distal end of the body; and wherein the plunger is slidable into the proximal end of the body and the cutting member is extendable from the distal end of the body.

In another embodiment, the cup portion is flared. In another embodiment, the cup portion is at least partially opaque.

The present disclosure includes disclosure of a device for discreetly piercing a skin of a patient, the device comprising a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, and a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body.

In at least one embodiment, the biasing member is disposed around the plunger. In at least one embodiment, the biasing member is connected to the plunger at a first location and is connected to the body at a second location. In at least one embodiment, the biasing member is disposed within the body. In at least one embodiment, the biasing member is disposed external to the body. In at least one embodiment, the cutting member is a blade. In at least one embodiment, the cutting member is a plurality of needles. In at least one embodiment, the device further comprises a depth adjustment member coupled to the device, the depth adjustment configured to adjust a distance the cutting member can extend from the body.

In at least one embodiment, the device further comprises a cup portion coupled to or formed as part of the body, the cup portion extending from the body outward and toward the distal end of the body. In at least one embodiment, the cup portion has a circumferential distal portion. In at least one embodiment, the cup portion has a transparent portion and a non-transparent portion.

In at least one embodiment, the body further comprises a grip. In at least one embodiment, the grip extends outward from the body. In at least one embodiment, the grip is defined as an indentation within the body.

In at least one embodiment, the device is configured so that when in use, and when the plunger is depressed and the distal end of the body contacts a patient's skin, the cutting member can pierce the patient's skin. In at least one embodiment, the device is configured so that when in use, and when the plunger is depressed and the distal end of the body contacts a patient's skin, the cutting member can pierce a boil or other skin condition of the patient's skin. In at least one embodiment, the device is configured so that when in use, and when the plunger is depressed and when the cup portion contacts a patient's skin, the cutting member can pierce the patient's skin. In at least one embodiment, the device is configured so that when in use, and when the plunger is depressed and when the cup portion contacts a patient's skin, the cutting member can pierce a boil or other skin condition of the patient's skin.

In at least one embodiment, the device is configured so that any pus or other material erupting from the boil or other skin condition is contained within the cup portion until the device no longer contacts the patient's skin.

The present disclosure includes disclosure of a device for discreetly piercing a skin of a patient, the device comprising a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, a depth adjustment member coupled to the device, the depth adjustment configured to adjust a distance the cutting member can extend from the body, and a cup portion coupled to or formed as part of the body, the cup portion extending from the body outward and toward the distal end of the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body. In at least one embodiment, the body further comprises a grip. In at least one embodiment, the grip extends outward from the body. In at least one embodiment, the grip is defined as an indentation within the body.

The present disclosure includes disclosure of a device for discreetly piercing a skin of a patient, the device comprising a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, and a cup portion coupled to or formed as part of the body, the cup portion extending from the body outward and toward the distal end of the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body, and wherein the body further comprises a grip.

In at least one embodiment, the device further comprises a draft adjustment member coupled to the device, the depth adjustment configured to adjust a distance the cutting member can extend from the body.

The present disclosure includes disclosure of a piercing method, the method comprising the step of positioning a device of the present disclosure relative to a patient's skin so that the distal end of the body contacts a patient's skin, and depressing the plunger to cause the cutting member to pierce the patient's skin.

The present disclosure includes disclosure of a piercing method, the method comprising the step of positioning a device of the present disclosure relative to a patient's skin so that the distal end of the body contacts a patient's skin, and depressing the plunger to cause the cutting member to pierce a boil or other skin condition of the patient's skin.

The present disclosure includes disclosure of a method, comprising the steps of positioning a portion of a device relative to a patient's skin, the device comprising a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, and a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, and depressing the plunger to cause the cutting member to extend from the distal end of the body so to pierce the patient's skin or a boil or other skin condition of the patient's skin.

In at least one embodiment, the device further comprises a cup portion coupled to or formed as part of the body, the cup portion extending from the body outward and toward the distal end of the body, and wherein the positioning step comprises the step of positioning the cup portion onto the patient's skin.

In at least one embodiment, the step of depressing the plunger is performed to case the cutting member to pierce the patient's skin, causing blood to erupt from the patient's skin, whereby the blood is contained within the cup portion.

In at least one embodiment, the step of depressing the plunger is performed to case the cutting member to pierce the boil or other skin condition of the patient's skin, causing pus or other purulent material or to erupt from the boil or other skin condition of the patient's skin, whereby the pus or other purulent material is contained within the cup portion.

In at least one embodiment, the cup portion has a window defined therein, and wherein the positioning step is performed to position the cup portion so that the cup portion faces a user of the device.

In at least one embodiment, the cup portion has a transparent portion and a non-transparent portion, and wherein the positioning step is performed to position the cup portion so that the transparent portion of the cup portion faces a user of the device.

In at least one embodiment, the device further comprises a depth adjustment member coupled to the device, the depth adjustment configured to adjust a distance the cutting member can extend from the body, and wherein the method further comprises the step of adjusting the depth adjustment member to a desired depth prior to the step of depressing the plunger.

The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:.

An overview of the features, functions and/or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described. Some of these non-discussed features, such as various couplers, etc., as well as discussed features are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and/or configuration.

It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.

In an exemplary embodiment, an exemplary sheathed cutting device <NUM> for treating boils and other skin conditions of the present invention is shown in <FIG>. As shown in <FIG>, the device <NUM> comprises a body <NUM>, and a cutting member <NUM> attached to plunger <NUM>, wherein the cutting member <NUM> and plunger <NUM> are positioned at least partially inside the body <NUM>. In a preferred embodiment the body <NUM> is generally cylindrical or barrel shaped and the cutting member <NUM> and plunger <NUM> (collectively referred to as parts of a cutting assembly <NUM> as shown in <FIG>) extend along a longitudinal axis <NUM> of the body <NUM>. The body <NUM> may also comprise two grips <NUM> disposed circumferentially on the body <NUM> or otherwise extending or protruding from body <NUM> to aid in manipulating the device <NUM> and plunger <NUM>.

Preferably, the cutting member <NUM> is a blade, such as a surgical blade as in the embodiment shown in <FIG>. Cutting member <NUM> may be other types of member(s) or object(s) capable of piercing or otherwise penetrating the skin, such as a plurality of needles.

The plunger <NUM> is located at or near the proximal end <NUM> of the body <NUM> and slidable further into the body <NUM>. As the cutting member <NUM> is attached to the plunger <NUM>, the movement of the plunger <NUM> causes corresponding movement of the cutting member <NUM>. That is, the clinician or other medical personnel can extend at least part of the cutting member <NUM> from the distal end <NUM> of the body <NUM>, through distal opening <NUM>, by pressing the plunger <NUM> into the body <NUM> from the proximal end <NUM> of the body <NUM>, such as in the direction indicated by arrow A in <FIG>.

Devices <NUM> of the present invention further comprise a biasing member <NUM>. The biasing member <NUM> biases the plunger <NUM>, and the corresponding cutting member <NUM>, to a position where the cutting member <NUM> is wholly within the body <NUM>, and thus hidden inside as shown in <FIG>. The biasing member <NUM> is preferably a spring element (a spring), or it can be another element, such as a flexible plastic element or a flexible metal element.

In the embodiment of <FIG>, the biasing member <NUM> is a spring is disposed external to the body <NUM> and surrounding the plunger <NUM>. A first end of the spring is adjacent and/or coupled to a portion of the plunger <NUM>, and a second end of the spring is adjacent and/or coupled to the body, such as at the proximal end <NUM> of the body <NUM>. This positioning causes the biasing member to push (exert a force) the plunger <NUM> and body <NUM> away from each other, retracting the cutting member <NUM> into the body <NUM>, such as shown in <FIG>.

Pressing the plunger <NUM> into the body <NUM> in the direction indicated by arrow A in <FIG> will extend the cutting member <NUM> from the distal end <NUM> of the body <NUM> and compress the spring. Upon release of the plunger <NUM>, the compressed spring will force the plunger <NUM> end and device <NUM> body <NUM> apart thereby retracting the cutting member <NUM> into the body <NUM> as shown in <FIG>.

The exemplary embodiment pictured in <FIG> also comprises a cup <NUM> portion. The cup portion <NUM> may be formed separately, as shown in <FIG>, or may be integral with the body <NUM>. During use, the cup portion <NUM> is placed over the treatment area (a location on the skin of a patient) such that the treatment area is shrouded, shielded, or otherwise hidden from view, at least partially, by the cup portion <NUM>. The cup portion <NUM> is flared, namely extending relatively outward and down from a relative center of the body <NUM>. Cup portion <NUM> can be rigid or formed of a soft material, such as a pliable or flexible plastic or other polymer-based material, so that it may be placed comfortably against a patient's body. Cup portion <NUM> may vary in shape or composition as necessary for the procedure.

The cup portion <NUM> may comprise or have varying levels of opacity, ranging anywhere between or from fully opaque, translucent, or fully transparent. An opaque cup portion <NUM> prevents the patient from seeing the procedure from being performed, namely the piercing of the skin by cutting member <NUM>, thereby reducing patient anxiety. Similarly, a translucent cup portion <NUM> can partially obscure the procedure, but also has the advantage of allowing some observation of the procedure. This can be useful if the clinician desires to confirm the alignment of the device <NUM> and treatment site, or to observe for the presence of blood, which indicates the patient's skin has been penetrated. The cup portion <NUM> could also comprise a portion comprising a first level of opacity and a second portion comprising a second level of opacity, such as where half (or a portion) of the cup portion <NUM> is opaque and half (or portion) is transparent. Cup portion <NUM> of the embodiments of the present invention has a translucent portion and a transparent portion, or an opaque portion and a translucent portion. The opaque section (or translucent portion) of the cup portion <NUM> can be oriented to face the patient, and the transparent portion (or the translucent portion) of the cup portion <NUM> can be oriented toward the clinician. The cup portion <NUM> could also be rotatable around the body <NUM> to orient the various portions of the cup portion <NUM> appropriately.

The device <NUM> may also include a depth adjustment member <NUM> as shown in <FIG>. For example, the device <NUM> may comprise a depth adjustable member <NUM>, such as one configured as a rotatable ring, disposed on the body <NUM>, wherein rotation of the ring adjusts the degree/extent of movement the plunger <NUM> is capable of and therefore the depth the cutting member <NUM> will penetrate into the treatment area when the plunger <NUM> is depressed.

In an additional embodiment, as shown in <FIG> and <FIG>, the device <NUM> comprises a plunger <NUM>, a cutting member <NUM>, and a body <NUM> as described in the embodiment of <FIG>. Similar to the embodiment of <FIG>, the plunger <NUM> and cutting member <NUM> of the embodiment of <FIG> and <FIG> are attached and located at least partially within the body <NUM>. The plunger <NUM> may be pressed into the body <NUM>, which then extends the cutting member <NUM> out of the body <NUM>. As shown in <FIG> and <FIG>, the body <NUM> may also comprise two grips <NUM> to aid in manipulating the device <NUM>.

The second embodiment of <FIG> and <FIG> further comprises a biasing member <NUM>, such as a spring. The biasing member <NUM> of the embodiment of <FIG> and <FIG> is disposed around the plunger <NUM> and within the body <NUM>. In this embodiment, the spring is hidden from view. The spring is configured to bias the plunger <NUM> out of the proximal end <NUM> of the body <NUM> which biases the cutting member <NUM> into the body <NUM> so that the cutting member <NUM> is withdrawn into the body <NUM>.

<FIG> shows an exemplary embodiment of a device <NUM> of the present disclosure, whereby the cutting member <NUM> comprises a plurality of needles, as referenced herein.

Devices <NUM>, as shown in <FIG>, also comprise a cup portion <NUM> as referenced herein in accordance with the present invention.

The embodiments of the present disclosure may be used to treat boils, pimples, and other conditions that cannot be properly addressed using a needle. Since a blade is used, an incision is formed rather than just a small opening, by way of cutting member <NUM>. Where the cutting member <NUM> comprises a plurality of needles, a large number of openings are formed, creating a similar effect to using a blade.

With respect to boils, for example, boils are frequently under pressure such that should the boil be pierced (via an initial incision), pus or other purulent material within the boil could "explode," such as to eject said pus or other purulent material, including infectious organisms, onto the user of the device <NUM>, and in particular into open orifices such as the eyes, nose, mouth, and/or skin. The inclusion of a cup portion <NUM> therefore operates to prevent splatter of said pus or other purulent material, which can lessen anxiety of the medical personnel using said device <NUM>.

A method of use of the present disclosure involves placing the distal end <NUM> of the body <NUM> or the cup portion <NUM> against the treatment area. The cutting member <NUM> is initially in a withdrawn position due to the actions of the biasing member <NUM>. The device <NUM> is aligned with the treatment site, so that upon depressing the plunger <NUM>, the cutting member <NUM> will contact the treatment site and break/pierce the skin of the patient. Where the embodiment being used comprises a cup portion <NUM>, a translucent or transparent cup portion <NUM> will allow the clinician to ascertain the alignment of the device <NUM> and the treatment site. If the embodiment being used includes a depth adjustment member <NUM>, the desired depth should be set before extending the cutting member <NUM>. Upon confirming correct alignment, the clinician can depress the plunger <NUM> into the body <NUM> which extends the cutting member <NUM> into the patient's skin. A transparent or translucent cup portion <NUM> allows the clinician to observe the cutting member <NUM>, and also observe for the presence of blood, confirming successful treatment. An opaque cup portion <NUM> will prevent the patient from observing the action of the cutting member <NUM>, thereby reducing anxiety.

<FIG> show additional embodiments of distal portions of devices <NUM> of the present disclosure. As shown in <FIG>, a cup portion <NUM> of an exemplary device <NUM> of the present disclosure can have a distal portion <NUM> that is not fully circumferential, whereby cup portion <NUM> defines a window therein whereby medical personnel using said device <NUM> can see the patient's skin underneath cup portion <NUM> during a lancing procedure. Window <NUM> can be defined within any portion of cup portion <NUM>, such as on a relative side of cup portion at or away from distal portion <NUM>.

The embodiment shown in <FIG>, a cup portion <NUM> of an exemplary device <NUM> of the present invention can have a distal portion <NUM> that is fully circumferential, whereby cup portion <NUM> has a transparent or relatively transparent (from transparent to translucent, including translucent) portion, referenced herein as transparent portion <NUM>, and further has a translucent to opaque, including opaque) portion, referenced herein as non-transparent portion <NUM>. In such an embodiment, medical personnel using said device <NUM> can see the patient's skin underneath cup portion <NUM> through transparent portion <NUM> positioned in view of the medical personnel, while the patient would not see transparent portion <NUM>, and would instead see non-transparent portion <NUM>, which shields the lancing procedure from the patient's view. The present disclosure includes disclosure of cup portions <NUM> that can be partially or fully transparent, partially or fully translucent, and/or partially or fully opaque.

<FIG> shows an exemplary embodiment of a device <NUM> of the present disclosure, whereby said device <NUM> has one or more grips <NUM> defined therein, forming effective indentations within body <NUM> of device <NUM>. As shown in <FIG>, <FIG>, and <FIG>, grip(s) <NUM> can extend from body <NUM> in various embodiments, and the present disclosure is not limited to only one type of grip <NUM> used with a particular device <NUM>. For example, an exemplary device <NUM> could have two or more grips <NUM>, with one or more grips <NUM> extending outward from body <NUM>, and with one or more grips <NUM> forming indentation(s) within body <NUM>.

While various embodiments of sheathed cutting devices and methods for using the same have been described in considerable detail herein, the embodiments are merely offered as nonlimiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

Claim 1:
A device for discreetly piercing a skin of a patient, the device comprising:
a body (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>);
a cutting member (<NUM>) attached to a plunger (<NUM>), the cutting member (<NUM>) and the plunger (<NUM>) positioned at least partially within the body (<NUM>); and
a biasing member (<NUM>) configured to bias the cutting member (<NUM>) to an initial position whereby the cutting member (<NUM>) is positioned fully within the body (<NUM>);
wherein the plunger (<NUM>) is slidable into the proximal end (<NUM>) of the body (<NUM>), causing the cutting member (<NUM>) to extend from the distal end of the body (<NUM>), and :
a cup portion (<NUM>) coupled to or formed as part of the body (<NUM>) and attached to the body (<NUM>) at a proximal end (<NUM>) of the cup portion (<NUM>), a distal end (<NUM>) of the cup portion (<NUM>) extending from the body (<NUM>) radially outward and toward the distal end (<NUM>) of the body (<NUM>) such that any section of the cup portion (<NUM>) not attached to the body (<NUM>) has a greater diameter than the body (<NUM>), and the cup portion (<NUM>) further comprising an opening defined in the distal end (<NUM>) of the cup portion (<NUM>), wherein the opening is larger than the body (<NUM>), and the body (<NUM>) extends into the distal end (<NUM>) of the cup portion (<NUM>);
wherein the cup portion (<NUM>) has a transparent portion on one relative side of the cup portion (<NUM>) for allowing a user of the device to see a piercing procedure, and a non-transparent portion on the other relative side of the cup portion (<NUM>) for shielding the patient from seeing the piercing procedure.