Planar alignment for asymmetric cutting members

Disclosed herein is a medical device. The medical device includes an outer tubular member and an inner tubular member. The outer tubular member has a distal end, an open window disposed at the distal end, and one or more dimples. The inner tubular member has a distal tip and one or more axial grooves. The inner tubular member is configured to be received within the outer tubular member. The one or more axial grooves and the one or more dimples are configured to align the distal tip of the inner tubular member with the open window of the outer tubular member. The open window of the outer tubular member and the distal tip of the inner tubular member are configured to cut tissue.

BACKGROUND

Field of the Invention

The invention relates to a medical device and more specifically relates to planar alignment for cutting members of the medical device.

Brief Description of Prior Developments

Conventional surgical shavers having reciprocating blades can have symmetric or asymmetric cutting features. For inner members that have a symmetric tip shape about the cutting axis, planar alignment is generally not needed. However, for beveled or other asymmetric inner tip configurations, the inner and outer member must remain in plane to allow desired cutting action. This is further important if the outer member is rotating by some means to reorient the position of the cutting opening.

Accordingly, there is a need to provide improved and reliable medical device configurations having alignment features for the reciprocating blades.

SUMMARY

In accordance with one aspect of the invention, a medical device is disclosed. The medical device includes an outer tubular member and an inner tubular member. The outer tubular member has a distal end, an open window disposed at the distal end, and one or more dimples. The inner tubular member has a distal tip and one or more axial grooves. The inner tubular member is configured to be received within the outer tubular member. The one or more axial grooves and the one or more dimples are configured to align the distal tip of the inner tubular member with the open window of the outer tubular member. The open window of the outer tubular member and the distal tip of the inner tubular member are configured to cut tissue.

In accordance with another aspect of the invention, a medical device is disclosed. The medical device includes an outer tubular member and an inner tubular member. The outer tubular member has a distal end, a longitudinal axis, an open window disposed at the distal end, and a groove. The inner tubular member has a distal tip, an outer surface, an inner surface, and a pin disposed on the outer surface, the inner tubular member configured to be received within the outer tubular member. The pin of the inner tubular member is configured to mate with the groove of the outer tubular member to align the distal tip of the inner tubular member with the open window of the outer tubular member. The open window of the outer tubular member and the distal tip of the inner tubular member are configured to cut tissue.

In accordance with another aspect of the invention, a medical device including an outer member and an inner member. The outer member has a distal open window, an outer wall, and an inner wall. The inner member has a distal tip, an outer wall and an inner wall. The inner tubular member is configured to be received within the outer member. A distal section of the outer wall of the inner member and a distal section of the inner wall of the outer member are both configured to have flat surfaces to align the distal tip of the inner member with the distal open window of the outer member. The distal open window of the outer member and the distal tip of the inner member are configured to cut tissue.

DETAILED DESCRIPTION

Referring toFIG.1, there is shown a partial section side 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 generally configured for use in the removal of nasal polyps, sub-mucosal debulk of turbinates, and functional endoscopic sinus surgery (FESS).

The medical device10, which may be a disposable debrider for example, comprises a housing12(which may have a pistol grip portion14), a blade tube section16, and a nosepiece18. The nosepiece18may be a rotatable nosepiece and is between the housing12and the blade tube section16. 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 blade tube section16of the device10can be configured with large and small shaver tubes, depending on anatomy and surgeon preference, and can also be adapted for bipolar or monopolar radio-frequency (RF) power. An external ESG (electrosurgical generator) may supply the RF power, for example.

The housing12comprises an interior cavity20sized and shaped to house actuation members of the device10. Additionally, in some embodiments the optional pistol grip portion14may include an interior cavity22which can also be sized and shaped to house actuation members (or other hardware) of the device10.

The blade tube section16comprises an outer blade tube24and an inner blade tube26, and the medical device10further comprises a blade drive system28mounted within the cavity20(or mounted within the cavity22) which is configured to drive the inner blade tube26. It should be noted that in some embodiments, the blade tubes24,26may comprise flexible and/or curved tubes.

Additionally, the medical device10comprises a connector30and a power cable32. The connector (or suction connection)30is configured to connect to a suction tube or a vacuum source. The connector30includes a dynamic seal34mounted inside of the connector30. The dynamic seal34is configured to provide a sealed interface between the connector30and an inner lumen36(via the outer surface of the inner blade tube26) of the inner blade tube26. The power cable32is configured to provide power to components(s) of the blade drive system28.

The outer blade tube (or outer tubular member)24is (rotatably or fixedly) mounted to the housing12and acts as a static member. For example, according to various exemplary embodiments, the nosepiece18can be mounted to the outer blade tube24and can optionally rotate the outer blade tube24independent of the housing12. The inner blade tube (or inner tubular member)26is slidably mounted inside the outer blade tube24(such that the inner blade tube26is slideably mounted within a lumen38of the outer blade tube24).

The inner blade tube26is configured to be forced distally [i.e. towards the distal end40] or proximally [i.e. towards the proximal end42] by the blade drive system28. The outer blade tube24comprises an opening (or open window)44proximate the distal end40which forms a cutting window46for the medical device10. The cutting window46is formed by a cutting edge48of the outer blade tube (i.e. the distal edge of the opening44) and a cutting tip50of the inner blade tube26. The reciprocal motion of the inner blade tube26provides for the cutting tip50to reciprocate relative to the cutting edge48to perform tissue cuts (i.e. by bringing the cutting tip50into alignment and out of alignment with the opening44of the outer blade tube24). In the embodiment shown inFIG.1, the cutting edge is at the cylindrical face portion of the cutting window46. However in alternate embodiments, the cutting edge may be provided at any suitable location along the distal end40.

It should be noted that although various exemplary embodiments of the invention have been described in connection with the cutting tip50comprising an angled straight edge configuration, alternate embodiments may comprise other suitable configurations. For example,FIGS.2-5illustrate alternate embodiments for the cutting tip50(see cutting tips50A,50B,50C,50D).

Referring now also toFIGS.6-8, an exemplary embodiment is shown which provides for planarly aligning the non-moving (outer) member24with the reciprocating (inner) member26of the reciprocating cutting instrument.

In the embodiment shown inFIGS.6-8, a formed dimple52in the outer member24, and an axial groove54in the inner member26are provided. The axial groove54can be provided at a collar56affixed (or otherwise coupled) to the inner member26. However, in alternate embodiments, the axial groove could be provided at the outer surface of the inner member26. According to various exemplary embodiments, the axial groove54can be any length longer than the cutting stroke of the inner member26, and is configured to receive the dimple52when the inner member26is inserted into the outer member24. The axial groove54and dimple52are sized to prevent rotation of the inner member26independent of the outer member24. With the receiving of the dimple52within the axial groove54, any rotation between the inner member26and the outer member24is prevented and a planar alignment is therefore provided between the inner member26and the outer member24. The planar alignment between the inner member26and the outer member24allows for a desired position of the cutting tip50relative to the cutting edge48(by preventing rotation of the inner member26[along a longitudinal axis of the inner member26] relative to the outer member24).

According to various exemplary embodiments, the axial groove features can be provided in more than one location so long as it remains adjacent to one of more of the dimple features, and may also be placed at any point along the axis of the blade tube section16so long as it remains adjacent the dimple feature. Additionally, in some embodiments, the dimple may comprise an elongated shape extending in the axial direction so as to form an axial dimple.

Referring now also toFIGS.9-11, another exemplary embodiment is shown which provides for planarly aligning a non-moving (outer) member124with a reciprocating (inner) member126of the reciprocating cutting instrument10. The non-moving (outer) member124is similar to the non-moving (outer) member24, and the reciprocating (inner) member126is similar to the reciprocating (inner) member26. However, in the embodiment shown inFIGS.9-11, a pin158is affixed (or coupled) to the outer surface of the inner tubular member126(seeFIG.9) and/or affixed (or coupled) to one or more collars160that are affixed (or coupled) to the inner tubular member126(seeFIG.10). A groove162in the outer member124is sized and shaped to allow for mating with the pin158. The groove162can be partially or completely through a wall section125of the outer tubular member124, and may also include a collar (not shown) affixed to the outside of the outer member. The groove162can also be formed completely through both the wall section125of the outer member124and collar (not shown), or completely through the wall section125of the outer member124and partially through the collar (not shown).

According to various exemplary embodiments, the mating groove feature162can be any length longer than the cutting stroke of the inner member126, and is configured to receive the pin158when the inner member126is inserted into the outer member124. The groove162and the pin158are sized to prevent rotation of the inner member126independent of the outer member124. With the receiving of the pin158within the groove162, any rotation between the inner member126and the outer member124is prevented and a planar alignment is therefore provided between the inner member126and the outer member124. The planar alignment between the inner member126and the outer member124allows for a desired position of the cutting tip50relative to the cutting edge48(by preventing rotation of the inner member126[along a longitudinal axis of the inner member126] relative to the outer member124).

According to various exemplary embodiments, the mating groove features can be provided in more than one location so long as it is adjacent to the pin or pins, and be placed at any point along the axis of the device so long as adjacent to pin.

Referring now also toFIGS.12-15, another exemplary embodiment is shown which provides for planarly aligning a non-moving (outer) member224with a reciprocating (inner) member226of the reciprocating cutting instrument10. The non-moving (outer) member224is similar to the non-moving (outer) member24, and the reciprocating (inner) member226is similar to the reciprocating (inner) member26. However, in the embodiment shown inFIGS.12-15, a machined flat section270is provided on the tip (or distal end) of the inner member226, and a mating general ‘circle D’ shaped feature272is provided on an inner surface of the outer member224. The inner member226fits concentrically inside the bore of outer member224in close diametric proximity along the expanded bearing section at the distal tip of the device. The wall section227of the inner member226can be decreased proximal of the distal bearing to provide relief clearance between the inside diameter (ID) of the outer member224and the outside diameter (OD) of the inner member226.

According to various exemplary embodiments, the outer member feature272can be any length longer than the cutting stroke of the inner member226, and is configured to receive the flat section270when the inner member226is inserted into the outer member224. The flat section270and the ‘circle D’ shaped features272are sized and shaped to prevent rotation of the inner member226independent of the outer member224. Since the ‘circle D’ shaped feature272and the flat section270(which provide bearing sections of the distal tips of the outer and inner members224,226) are in close fit, the inner member226is constrained from rotating about its axis independently of the outer member224.

With the receiving of the flat section270within the ‘circle D’ shaped feature272, any rotation between the inner member226and the outer member224is prevented and a planar alignment is therefore provided between the inner member226and the outer member224. The planar alignment between the inner member226and the outer member224allows for a desired position of the cutting tip50relative to the cutting edge48(by preventing rotation of the inner member226[along a longitudinal axis of the inner member226] relative to the outer member224).

According to various exemplary embodiments, the outer member feature can be provided in more than one location, and be placed at any point or points along the axis of the device. The outer member can be a single piece or multiple pieces in which the wall of the outer tubular member and the section comprising the ‘circle D’ shaped feature are affixed by welding or other suitable means.

Technical effects of any one or more of the exemplary embodiments provide significant advantages over conventional configurations by planarly aligning a non-moving (outer) member with a reciprocating (inner) member of a reciprocating cutting instrument. Another technical effect of the various exemplary embodiments is that the alignment features can be used with both straight and curved devices.

While various exemplary embodiments of the invention have been described in connection with a blade tube section16having a cutting edge48at the cutting window46of the outer blade tube24,124,224, other configurations may be provided. For example, an alternate embodiment of a blade tube section316is shown inFIG.16(illustrating a cross-section view [top] and a top plan view [bottom]). Similar to the blade tube section16, the blade tube section316comprises an outer blade tube324and an inner blade tube326configured to be driven by the blade drive system28. However in this embodiment, the inner blade tube326comprises a cutting window347and a cutting edge349. The cutting window347is configured to be aligned with the window346of the outer blade tube324such that the cutting is provided when tissue371extends through the windows346,347and a backwards motion of the inner blade tube326(towards the proximate end [see arrow395]) causes the cutting edge349to cut through the tissue371.

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: an outer tubular member having a distal end, an open window disposed at the distal end, and one or more dimples; and an inner tubular member having a distal tip and one or more axial grooves, the inner tubular member configured to be received within the outer tubular member; wherein the one or more axial grooves and the one or more dimples are configured to align the distal tip of the inner tubular member with the open window of the outer tubular member, and wherein the open window of the outer tubular member and the distal tip of the inner tubular member are configured to cut tissue.

A medical device as above wherein the distal tip of the inner tubular member comprises an asymmetric distal tip.

A medical device as above wherein the one or more dimples of the outer tubular member comprise one or more axial dimples.

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

A medical device as above wherein the medical device is configured to cut tissue when the inner tubular member reciprocates.

A medical device as above further comprising a collar connected to the inner tubular member, wherein the collar comprises the one or more axial grooves.

In another exemplary embodiment, a medical device comprising: an outer tubular member having a distal end, a longitudinal axis, an open window disposed at the distal end, and a groove; and an inner tubular member having a distal tip, an outer surface, an inner surface, and a pin disposed on the outer surface, the inner tubular member configured to be received within the outer tubular member; wherein the pin of the inner tubular member is configured to mate with the groove of the outer tubular member to align the distal tip of the inner tubular member with the open window of the outer tubular member, and wherein the open window of the outer tubular member and the distal tip of the inner tubular member are configured to cut tissue.

A medical device as above wherein the groove extends along a direction of the longitudinal axis.

A medical device as above wherein the distal tip of the inner tubular member comprises an asymmetric distal tip.

A medical device as above wherein the medical device is configured to cut tissue when the inner tubular member reciprocates relative the outer tubular member.

A medical device as above further comprising a collar connected to the inner tubular member, wherein the pin is at the collar.

A medical device as above wherein the groove is at a wall section of the outer tubular member.

In another exemplary embodiment, a medical device comprising: an outer member having a distal open window, an outer wall, and an inner wall; and an inner member having a distal tip, an outer wall and an inner wall, the inner tubular member configured to be received within the outer member; wherein a distal section of the outer wall of the inner member and a distal section of the inner wall of the outer member are both configured to have flat surfaces to align the distal tip of the inner member with the distal open window of the outer member, and wherein the distal open window of the outer member and the distal tip of the inner member are configured to cut tissue.

A medical device as above wherein the distal tip of the inner member comprises an asymmetric distal tip.

A medical device as above wherein the inner member is configured to reciprocate relative the outer member.

A medical device as above wherein the medical device is configured to cut tissue when the inner member reciprocates.

A medical device as above wherein the flat surfaces are configured to prevent rotation between the inner member and the outer member.

A medical device as above wherein the flat surface of the outer member is at an inner wall section of the outer member.

A medical device as above wherein the flat surface of the inner member is at an outer wall section of the inner member.

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.