Disposable debrider with cannulated solenoid

Disclosed herein is a medical device. The medical device includes two coaxially aligned solenoids and a cannulated armature configured to be received within the two coaxially aligned solenoids.

BACKGROUND

Field of the Invention

The invention relates to a medical device and more specifically relates to a disposable debrider with a cannulated solenoid.

Brief Description of Prior Developments

Conventional shavers generally use a rotational motor coupled with a parallel gear train to impart oscillatory motion. For example, PolypVac (manufactured by Laurimed) uses reciprocating cutting motion, presumably powered by Suction (mechanism unknown). Other known ideas are worm gears and ‘levelwind gears’ or ‘diamond screws’. All of these known technologies involve multiple moving components in which a power source, often rotational, translates the input motion to a linear repeating cutting motion. This reciprocating motion has limitations in that it is often complex relative to oscillatory or rotational cutting, and it doesn't lend well to curved devices. This complexity is often quite expensive and may be tedious to manufacture, particularly in disposable devices. Additionally, since most shaver systems encompasses both blades and burrs, reciprocation is not a good choice for durable equipment because its limitation is supporting drilling and curved devices.

The PolypVac mechanism uses operating room or office-equipped vacuum suction to create and power the cutting motion. Because medical suction devices are of varying quality, strengths and reliabilities, cutting performance and efficiency is often lacking in both power of cutting motion and repeatability of the performance, particularly in the cost-sensitive package of a disposable device. Ostensibly, the mechanical complexity of such a mechanism packaged for one-time use is also subject to quality and reliability problems in the field. Additionally, it's believed that the vacuum pressure used to power the device subtracts from the critical aspiration power needed to engage and pull tissue in to the cutting window. Aspiration can be a critical input feature of a Microdebrider with respect to cutting performance.

Accordingly, there is a need to provide improved and reliable medical device configurations.

SUMMARY

In accordance with one aspect of the invention, a medical device is disclosed. The medical device includes two coaxially aligned solenoids and a cannulated armature configured to be received within the two coaxially aligned solenoids.

In accordance with another aspect of the invention, a medical device is disclosed. The medical device includes two solenoids, a cannulated armature, an inner tubular member, and an outer tubular member. The two solenoids are configured to be linearly spaced apart by a spacer. The cannulated armature is configured to be received within the two solenoids. The inner tubular member has a distal end and an open window disposed at the distal end. The inner tubular member is configured to be received within the cannulated armature. The outer tubular member having a distal end and an open window disposed at the distal end. The open window of the inner tubular member and the open window of the outer tubular member form a cutting tool.

In accordance with another aspect of the invention, a medical device is disclosed. The medical device includes a handle, two separate solenoids, a cannulated armature, an inner tubular member, and an outer tubular member. The two separate solenoids are configured to be stationary inside the handle. The cannulated armature is configured to be received within the two solenoids. The inner tubular member has a distal end and an open window disposed at the distal end. The inner tubular member is configured to be received within the cannulated armature. The outer tubular member has a distal end and an open window disposed at the distal end. The open window of the inner tubular member and the open window of the outer tubular member form a cutting tool.

DETAILED DESCRIPTION

Referring toFIG. 1, there is shown a perspective view of a medical device10incorporating features of the invention. Although the invention will be described with reference to the exemplary embodiments shown in the drawings, it should be understood that the invention can be embodied in many alternate forms of embodiments. In addition, any suitable size, shape or type of elements or materials could be used.

According to various exemplary embodiments, the medical device10is configured for use in the removal of nasal polyps, sub-mucosal debulk of turbinates, and functional endoscopic sinus surgery (FESS), primarily in the office environment and/or cost-sensitive regions.

The medical device10, which may be a disposable debrider for example, comprises a housing (which may form a handpiece portion)12, a blade tube section14, and a nosecone16. The nosecone16may be a rotatable nosecone and is between the housing12and the blade tube section14. However it should be noted that exemplary embodiments of the medical device may comprise any suitable configuration such as configurations having a nosecone coupled to an outer member (of the housing), or any other suitable curved or straight debrider configuration which may comprise an irrigation feature, for example. The medical device10is configured to be connected to a reusable power supply18(which may have a similar physical size to that of a laptop computer power supply, for example) which is used to power the device10and may be universally compatible with all worldwide wall power supplies and plug styles. A length of disposable power cord20may be attachable to the handpiece portion12and plugs in to the power supply18. A user-selectable speed dial22may also be provided on the power supply18. The blade tube section14of the device10can be configured with large and small shaver tubes, depending on anatomy and surgeon preference, and can also be adapted for bipolar (preferred) or monopolar radio-frequency (RF) power. An external ESG (electrosurgical generator) may supply the RF power, for example. A shaver activation button24is located on the housing12in an ergonomic location to power and control the shaver blade. However, in alternate embodiments the shaver activation button may be provided on a handle portion26attached to the housing12, or activated by a separate footswitch (instead of a button on the housing). Additionally, a suction connection28for a tube may be provided adjacent the power cord.

Referring now also toFIGS. 2 and 3, the medical device10further comprises a solenoid30mounted in the housing12on the main blade and aspiration pathway axis, and the blade tube section14comprises an outer blade tube32and an inner blade tube34.

The solenoid30comprises a static hollow cylindrical section36with an energizing coil31, and a dynamic “plunger” piece38in the center of the hollow static section that is inducted to move axially with a known force when the coil31is electrically energized. This provides for the medical device10to generally include only one moving part. The plunger38comprises a hole (or opening)39extending along a central axis of the plunger38. The opening39is configured to receive the inner blade tube34such that the inner blade tube34is fixed to the plunger38.

The outer blade tube32is (rotatably or fixedly) mounted to the housing12and acts as a static member, wherein the inner blade tube34is slidably mounted inside the outer blade tube32. When the coil31is energized, the inner blade tube34is then forced distally [i.e. towards the distal end40] (or proximally [i.e. towards the proximal end42] depending on the construction, choice of solenoid type, and desired cutting motion) to cut tissue. One or more springs44are provided to return the plunger38to its ‘home’ position with a biasing force of the spring(s)44. The center aspiration pathway is then created by the inner blade/tube lumen and the inner lumen of the plunger piece. Additionally, in some embodiments of the shaver tip window geometry, the inner blade is rotatably coupled to the outer blade tube.

Referring now also toFIGS. 4 and 5, another embodiment of a medical device is shown. The medical device100shown inFIGS. 4 and 5is similar to the medical device10(shown inFIGS. 1-3) and similar features are similarly numbered. However, instead of using one solenoid that is energized for the “power” stroke with a spring to achieve the return stroke (as inFIGS. 1-3), the medical device100uses two opposing solenoids.

Similar to the medical device10, the medical device100comprises a housing112, a blade tube section114, a nosecone116, and a handle126. The nosecone116may be a rotatable nosecone and is between the housing112and the blade tube section114. Additionally, the medical device100comprises a suction connection128(which may be coaxial or off-axis with the solenoid axis) and a power cord connection [not shown].

The medical device100further comprises a dual solenoid assembly130mounted in the housing112on the main blade and aspiration pathway axis, and the blade tube section114comprises an outer blade tube132and an inner blade tube134.

The dual solenoid assembly130comprises opposing solenoids130A,130B, linearly spaced between a proximal endcap133and a distal endcap135, and separated by a coil spacer137. The solenoid130A is between the coil spacer137and the proximal endcap133. The solenoid130B is between the coil spacer137and the distal endcap135. The solenoid130A comprises a static hollow cylindrical section136A and an energizing coil131A. Similarly, the solenoid130B comprises a static hollow cylindrical section136B and an energizing coil131B.

A cannulated armature138is configured to be received within the hollow cylindrical sections of the solenoids130A,130B. The cannulated armature138comprises a cylindrical shape and is configured to be movable between the endcaps133,135. The cannulated armature138comprises a hole (or opening)139extending along a central axis of the armature138. The opening139is configured to receive the inner blade tube134such that the inner blade tube134is fixed to the armature138. The cannulated armature138is configured to be driven by the solenoids130A,130B to reciprocate between the endcaps133,135.

According to various exemplary embodiments, the outer blade tube and the inner blade tube each comprise an open window (146,148, respectively) at a distal end140of the device100. However, in some alternate embodiments only the outer blade tube comprises an open window. It should further be noted that although various exemplary embodiments of the invention have been described in connection with the inner and/or outer blade tube as having an open window, alternate embodiments may comprise inner and/or outer blade tubes having two or more windows.

The outer blade tube132is mounted to the housing112and acts as a static member, wherein the inner blade tube134is slidably mounted inside the outer blade tube132. The open windows146,148at the distal end provide a cutting feature for the medical device100, as the cannulated armature138is configured to be driven by the solenoids130A,130B (when the coils131A,131B are electrically energized) to reciprocate the inner blade tube134to perform tissue cuts (by bringing the window148of the inner blade tube134into alignment and out of alignment with the window146of the outer blade tube132).

For example, when the coil131B is energized this induces the movement of the armature138distally [i.e. towards the distal end140] for the power stroke (or forward stroke direction) and the attached inner blade tube134is also forced distally (seeFIG. 4where the device cutting window is closed [by having the inner blade tube at a position closest to the distal end] and the armature is at the end of the power stroke [and proximate the distal end cap135]). Similarly, when the coil131A is energized this induces the movement of the armature138proximally [i.e. towards the proximal end142] for the return stroke (or reverse stroke direction) and the attached inner blade tube134is also forced proximally (seeFIG. 5where the device cutting window is open [by having the inner blade tube at a position closest to the proximal end] and the armature138is at the end of the return stroke [and proximate the proximal end cap133]).

According to various exemplary embodiments, the solenoid assembly130comprises a casing150surrounding the solenoid coils131A,131B and the coil spacer137(best shown inFIGS. 6-9). The casing150comprises a general tubular shape and is configured to receive the proximal end cap133at one end and the distal end cap135at an opposite end. The solenoid assembly130may further comprise an armature sleeve (or brass guide tube)152between the solenoid coils131A,131B and the armature138. Additionally, elastomer spacers154may be provided between the proximal end cap133and a proximal end of the armature138, and between the distal end cap135and a distal end of the armature138. Further, coil wire leads156may extend from ends of the solenoid coils131A,131B, however any suitable type of power connection to the solenoid coils may be provided.

Technical effects of any one or more of the exemplary embodiments provide significant advantages over conventional configurations by providing a stronger power stroke (no energy diverted to compress a spring) and a stronger return stroke. Also, both directions of the stroke can now be controlled by the timing of current supplied to each coil, unlike the passive spring return. It should further be noted that various exemplary embodiments may comprise solenoids having different sizes and/or stroke powers. Additionally, alternate control options related to forward/backward stroke speeds, dwells, etc., may be provided.

A further technical effect of any one or more of the exemplary embodiments provides configurations which can perform each stroke (power and return) independently. This allows for a functionality which the doctor can choose “window closed” or “window open” configurations when the device is idle. This is a desirable function because many doctors want a closed window while the approach the treatment area, and then an open widow once they are near the target tissue.

Additional technical effects of any one or more of the exemplary embodiments provides an inner blade tube that is flexible (such as one fabricated from either plain or reinforced nylon tubing, or possibly PEEK tubing, for example). This feature can reduce the resistive losses between the inner and outer blade tubes when the outer blade tube is subjected to side loading, thus keeping the cutting stroke powerful and allows for curved or malleable embodiments.

Below are provided further descriptions of various non-limiting, exemplary embodiments. The below-described exemplary embodiments may be practiced in conjunction with one or more other aspects or exemplary embodiments. That is, the exemplary embodiments of the invention, such as those described immediately below, may be implemented, practiced or utilized in any combination (e.g., any combination that is suitable, practicable and/or feasible) and are not limited only to those combinations described herein and/or included in the appended claims.

In one exemplary embodiment, a medical device comprising two coaxially aligned solenoids and a cannulated armature configured to be received within the two coaxially aligned solenoids.

A medical device as above, wherein the two coaxially aligned solenoids are linearly spaced.

A medical device as above, further comprising an inner tubular member having a distal end and an open window disposed at the distal end, the inner tubular member configured to be received within the cannulated armature.

A medical device as above, further comprising an outer tubular member having a distal end and an open window disposed at the distal end, wherein the open window of the inner tubular member and the open window of the outer tubular member form a cutting tool.

A medical device as above, further comprising a metal spacer between the two coaxially aligned solenoids.

A medical device as above, wherein further comprising a casing, wherein the two coaxially aligned solenoids are between the cannulated armature and the casing.

A medical device as above, further comprising a proximal endcap and a distal endcap, wherein the proximal endcap is received by one end of the casing, and wherein the distal endcap is received by an opposite end of the casing.

A medical device as above, wherein the medical device comprises only two coaxially aligned solenoids.

In another exemplary embodiment, a medical device, comprising: two solenoids configured to be linearly spaced apart by a spacer; a cannulated armature configured to be received within the two solenoids; an inner tubular member having a distal end and an open window disposed at the distal end, the inner tubular member configured to be received within the cannulated armature; and an outer tubular member having a distal end and an open window disposed at the distal end, wherein the open window of the inner tubular member and the open window of the outer tubular member form a cutting tool.

A medical device as above, further comprising a casing, wherein the two solenoids are between the cannulated armature and the casing.

A medical device as above, further comprising a proximal endcap and a distal endcap, wherein the proximal endcap is received by one end of the casing, and wherein the distal endcap is received by an opposite end of the casing.

A medical device as above, wherein the cannulated armature is configured to be movable relative to the two solenoids.

A medical device as above, further comprising an armature sleeve between the cannulated armature and the two solenoids.

A medical device as above, further comprising a first elastomer spacer and a second elastomer spacer, wherein the cannulated armature is between the first elastomer spacer and the second elastomer spacer.

In another exemplary embodiment, a medical device, comprising: a handle; two separate solenoids configured to be stationary inside the handle; a cannulated armature configured to be received within the two solenoids; an inner tubular member having a distal end and an open window disposed at the distal end, the inner tubular member configured to be received within the cannulated armature; and an outer tubular member having a distal end and an open window disposed at the distal end, wherein the open window of the inner tubular member and the open window of the outer tubular member form a cutting tool.

A medical device as above, further comprising a spacer between the two separate solenoids.

A medical device as above, wherein the two separate solenoids are linearly spaced.

A medical device as above, wherein the inner tubular member is configured to be movable relative to the outer tubular member.

A medical device as above, further comprising a casing, wherein the two separate solenoids are between the cannulated armature and the casing.

A medical device as above, further comprising an armature sleeve, wherein the armature sleeve is between the cannulated armature and the solenoids.

It is noted that the term “cannulated” used throughout the specification refers to a general ‘tube’ or ‘tubular’, or ‘hollowed out cylindrical’ shape, or any general cylinder shape having an outside diameter and an inside diameter, for example.

It should be understood that components of the invention can be operationally coupled or connected and that any number or combination of intervening elements can exist (including no intervening elements). The connections can be direct or indirect and additionally there can merely be a functional relationship between components.