Curved blade flex wrap with seal lining

A surgical device for cutting bone or tissue in a patient can include a cutting blade having a rigid portion, a flexible portion, and a liner to provide a seal to the flexible portion. The blade has an outer member and an inner member disposed within a lumen of the outer member. The inner member has a rigid portion and a flexible portion. The liner can be disposed within a lumen of the inner member and can engage the rigid portion such as to retain the liner adjacent to the flexible portion of the inner member.

TECHNICAL FIELD

This document pertains generally, but not by way of limitation, to surgical instruments and methods for the manufacture and use of such surgical instruments and, more particularly, to cutting instruments comprising a flexible portion for insertion through a curved path.

BACKGROUND

Various surgical devices have been developed for inserting into and through a curved lumen or other curved pathway in a body, for example as are described in U.S. Pat. Nos. 10,206,706; 10,166,013; 9,308,013; 8,721,826; 7,338,495, 5,833,692; 5,322,505; and 5,286,253. These surgical devices may include a flexible portion configured to bend or flex during passage through the lumen or other pathway in the body.

OVERVIEW

The present technology relates to devices for cutting tissue in a body. A cutting device can include a generally tubular member. The tubular member can include a blade portion, a rigid portion, a flexible portion between the blade portion and the rigid portion and, and a liner disposed within the flexible portion of the cutting device. The rigid portion can be disposed at the proximal end of the cutting device. The blade portion can include one or more cutting windows and one or more cutting elements or cutting surfaces such as disposed at the distal end of the device. The flexible portion can include one or more strips of a flexible material, such as can be wound or wrapped around an axis of the tubular member in an intermediate region between the blade portion and the connecting or rigid portion. By providing a liner to the flexible portion of the cutting device, a seal is formed. The seal may help reduce loss of suction and may help inhibit or prevent compromised cutting performance and/or failure of the cutting device during use.

The following aspects and discussion illustrate various configurations of the disclosed device and methods.

Aspect 1 can include an outer member including a cutting window, an inner member disposed at least partially within the outer member, and a liner. The outer member can include a tube that defines a first lumen. The inner member can extend through at least a portion of the first lumen defined by the outer member. The inner member may include a cutting surface and at least two portions, each of the two portions having a different flexibility. For instance, the inner member may comprise a rigid portion and a flexible portion, the flexible portion being more flexible than the rigid portion. The liner may be configured to be disposed within the inner member. The inner member can define a second lumen and the liner can extend through at least a portion of the second lumen. The liner may include a locking feature configured to engage the rigid portion of the inner member, such that at least one end of the liner is retained at a predetermined position within the lumen.

Aspect 2 can include, use, or can optionally be combined with the subject matter of Aspect 1, or any one or any combination of elements of Aspect 1, to optionally include or use a locking feature comprising an end wall of the liner.

Aspect 3 can include, use, or can optionally be combined with the subject matter of Aspects 1 or 2, or any one or any combination of elements of Aspects 1 or 2, to optionally include or use a locking feature comprising a flared region of a liner outer wall or a projection extending from the liner outer wall.

Aspect 4 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 3, or any one or any combination of elements of Aspects 1 through 3, to optionally include or use an inner wall comprising a stop configured to engage the locking feature to retain the liner at the predetermined position.

Aspect 5 can include, use, or can optionally be combined with the subject matter of Aspect 4, or any one or any combination of elements of Aspect 4, to optionally include or use a stop disposed adjacent to a distal end of the at least one rigid portion.

Aspect 6 can include, use, or can optionally be combined with the subject matter of Aspects 4, or any one or any combination of elements of Aspect 4, to optionally include or use a stop disposed adjacent to a proximal end of the at least one rigid portion.

Aspect 7 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 6, or any one or any combination of elements of Aspects 1 through 6, to optionally include or use a lumen of the inner member having a first inner diameter and a second inner diameter, different from the first inner diameter, and a locking feature configured to engage the inner wall at a transition between the first inner diameter and the second inner diameter.

Aspect 8 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 7, or any one or any combination of elements of Aspects 1 through 7, to optionally include or use an inner wall having a first thickness and a second thickness, different from the first thickness, and the locking feature is configured to engage the inner wall at a transition between the first thickness and the second thickness of the inner wall.

Aspect 9 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 8, or any one or any combination of elements of Aspects 1 through 8, to optionally include or use an at least one rigid portion having a first rigid portion and a second rigid portion axially spaced from the first rigid portion, and the locking feature having a first locking feature configured to engage the inner wall of the first rigid portion and a second locking feature configured to engage the inner wall of the second rigid portion.

Aspect 10 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 9, or any one or any combination of elements of Aspects 1 through 9, to optionally include or use a locking feature configured to engage a recess or aperture in the inner wall of the at least one rigid portion.

Aspect 11 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 10, or any one or any combination of elements of Aspects 1 through 10, to optionally include or use an inner wall comprising a recess or aperture configured to engage the locking feature.

Aspect 12 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 11, or any one or any combination of elements of Aspects 1 through 11, to optionally include or use an inner wall of the at least one rigid portion that extends perpendicular to a longitudinal axis of the inner member.

Aspect 13 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 12, or any one or any combination of elements of Aspects 1 through 12, to optionally include or use a predetermined position that is adjacent to the at least one flexible portion.

Aspect 14 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 13, or any one or any combination of elements of Aspects 1 through 13, to include or use a liner configured to engage an inner wall of the at least one rigid portion to form a seal between the liner and the inner member.

Aspect 15 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 14, or any one or any combination of elements of Aspects 1 through 14, to optionally include or use a method of forming a surgical tool comprising a cutting window, a cutting surface and a flexible portion, the method comprising inserting a liner into a lumen of a first member comprising the cutting surface and inserting the first member into a lumen of a second member comprising a cutting window.

Aspect 16 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 15, or any one or any combination of elements of Aspects 1 through 15, to optionally include or use a method in which the first member is inserted into the lumen of the second member after the liner is inserted into the lumen of the first member.

Aspect 17 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 16, or any one or any combination of elements of Aspects 1 through 16, to optionally include or use a method further comprising applying a temperature greater than 25° C. to the liner after the liner is inserted into the lumen of the first member.

Aspect 18 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 17, or any one or any combination of elements of Aspects 1 through 17, to optionally include or use a method further comprising applying a fluid to the liner after the liner is inserted into the lumen of the first member.

Aspect 19 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 18, or any one or any combination of elements of Aspects 1 through 18, to optionally include or use a method further comprising applying a pressure to the liner after the liner is inserted into the lumen of the first member.

Aspect 20 can include, use, or can optionally be combined with the subject matter of Aspects 1 through 19, or any one or any combination of elements of Aspects 1 through 19, to optionally include or use a method in which the liner is cooled to a temperature below 25° C. before the liner is inserted into the lumen of the first member.

Aspect 21 can include or use any one or any combination of Aspects 1 through 20 or any one or any combination of elements of Aspects 1 through 20.

This overview is intended to provide a generalized summary of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application and the inventions disclosed herein.

DETAILED DESCRIPTION

The present disclosure is directed to a surgical cutting device comprising a flexible portion and related combinations, systems and methods. The devices, apparatuses, combinations, systems, methods and techniques of the present application are not limited to any particular type of procedure or use. Indeed, the present devices, apparatuses, combinations, systems, methods and techniques can be utilized in any medical procedure that uses a cutting device.

A surgical device may include a flexible portion that may include a tubular structure that is formed of a material configured to flex during insertion or movement through a lumen or other pathway in a body. For example, without limitation, a surgical device may include a debrider, a burr, a rasp, a blade, a knife, a suction, a forceps, a probe, a curette, a cannula, a snare, a scope, or the like. It may be beneficial for the surgical device to be deformable, malleable, or configured to flex such that the surgical device can be manipulated through a passage or within cavity in a human or animal body that is not entirely straight, through a narrow passage, or around an obstruction in a passage or cavity, e.g., a nasal passage, a sinus passage, a laryngeal passage, a gastrointestinal passage, a kidney passage, a urogenital passage, or other narrow or tortuous passage in a body. To enhance flexing of the surgical device, the tubular structure may include a flexible material that is wrapped or wound around an axis of the tubular structure such as to help provide flexibility in one or more portions of the tubular structure. The flexible surgical device can be configured to provide cutting of tissue in or adjacent to the path of insertion or movement of the surgical device. The cutting may be provided by reciprocation, by oscillation or by rotation of a tubular structure that has a blade, serrations, teeth, burr, or one or more other cutting elements. A flexible cutting assembly can include an outer tubular structure. An inner tubular structure can be co-axially disposed within the outer tubular structure. The inner tubular structure can include one or more flexible regions. A cutting element or blade can be disposed at a distal end of the inner tubular structure. The cutting element or blade can be exposed from an opening at a distal end of the outer tubular structure such as to allow cutting of anatomical tissue at the surgical site when the inner tubular member is reciprocated, oscillated, or is rotated within the outer tubular member.

The flexible cutting device can also be configured to provide suction. Such suction can be useful to withdraw tissue that has been excised, such as to help provide for more efficient cutting by the surgical device. For example, the internal lumen of the inner tubular member can be used to provide suction to aspirate anatomical tissue, body or irrigation fluid, or both, such as through the lumen of the inner tubular structure. An annular gap between the internal diameter of the outer tubular structure and the external diameter of the inner tubular structure can provide another path such as for suction or as an irrigation passage to supply irrigation fluid to the surgical site. Cutting devices with a flexible portion can use one or more strips of material spirally wrapped or wound about an axis of the inner tubular structure such as to impart flexibility to the flexible portion. The flexible portion of the tubular structure may have a spiral construction, such as of a plurality of strips compiled into one or more than one combination of counter helical spirals. The construction of the strips and/or helical spiral arrangement of the strips may not be of a completely sealed construction. Sometimes, wrapped or wound flexible materials can tend to partially or fully unwind when rotated in a direction opposite their winding, resulting in gaps in the flexible tubular structure. A degradation or loss of suction can occur due to absence of a completely sealed construction of the flexible wrap material. A loss of suction can also occur due to gaps that may exist or form in the flexible wrap material. The loss of suction can cause the device to clog when aspirating cut tissue, leading to inefficient cutting, device failure, or both.

There is a need for a flexible tubular surgical device capable of maintaining suction when transmitting torque, such as can be addressed by a flexible tubular cutting device that has a sealed flexible wrap portion to enhance suction during use, such as described herein. There is also a need for a flexible cutting device that allows a curved cutting element or blade to bend around a radius such as while in an oscillating mode.

FIGS.1A and1Billustrate examples of a curved blade101that can be used as part of a combination, assembly, kit, or system100such as for shaving, cutting, resecting, abrading and/or removing tissue, bone and/or bodily fluids from a surgical site. The curved blade101can include at least one relatively more rigid portion19,20,21,22, and at least one relatively more flexible portion, such as one of23or24. The curved blade101can comprise a liner10, an outer member11such as extending between a proximal end13and a distal end15, and an inner member12such as extending between a proximal end14and a distal end16. The outer member11can be configured with a connector7adjacent to the proximal end13. The inner member12can be configured with a connector8adjacent to the proximal end14. The connector7and the connector8can be configured to detachably couple the inner member12to the outer member11. For example, the connector8and the connector7can be configured to detachably couple the inner member12to the outer member11such that the inner member12can be reciprocated, rotated or oscillated relative to the outer member11. The connector7and the connector8can be configured to detachably couple the curved blade101to a tool handle102. For example, the connector7and the connector8can be configured to detachably couple the curved blade101to a tool handle102(illustrated inFIG.1A) such that the outer member11of the curved blade101is stationary with respect to the tool handle102. The outer member connector7and the inner member connector8can be configured to detachably couple the curved blade101to a tool handle102such that the inner member12of the curved blade101can reciprocate, rotate or oscillate relative to the tool handle102, relative to the outer member11, or relative to both the tool handle102and the outer member11. The outer member connector7and the inner member connector8can be configured to detachably couple the curved blade101to a tool handle102such that the outer member11can reciprocate, rotate or oscillate relative to the tool handle102, relative to the inner member12, or relative to both the tool handle102and the inner member12.

Any means suitable for fixedly or detachably coupling an inner member to an outer member can be used to couple inner member12to outer member11. Any connector suitable for detachably coupling a cutting device to a tool handle102can be used to detachably couple the curved blade101to a tool handle102. Some examples of connectors for coupling a blade to a tool handle are described in U.S. Pat. Nos. 5,286,253; 7,338,495; and 9,308,103. For example, a connector such as described in U.S. Pat. No. 9,308,103, which is incorporated herein by this reference, can be used to detachably couple the inner member12to the outer member11, and/or to detachably couple the curved blade101to a tool handle102. A curved blade101can be detachably coupled to a tool handle102such that the inner member12of the curved blade101can reciprocate, rotate or oscillate with respect to the outer member11, with respect to the tool handle102, or with respect to both outer member11and the tool handle102. The outer member11of the curved blade101can be detachably coupled to a tool handle102such that the outer member11can reciprocate, rotate or oscillate with respect to the tool handle102, with respect to the inner member12, or with respect to both the tool handle102and the inner member12.

The curved blade101can have a generally tubular structure. As illustrated inFIGS.1B,6, and7, an outer member11can extend a length88between a proximal end13and a distal end15. As shown inFIGS.8and9, an outer member11can comprise a lumen17. The outer member11can have an outer diameter86and an inner diameter84(FIGS.6and8). An outer member11can have any length88, any outer diameter86and any inner diameter84. In one aspect, an outer member11can have a length88between about 10 cm and about 1 mm. In certain aspects, an outer member11can have a length88between about 10 mm to about 1 mm. In a preferred aspect, an outer member can have a length88between about 5 mm to about 1 mm. In one aspect, an outer member11can have an outer diameter86between about 10 cm and about 0.1 mm. In an aspect, an outer member11can have an outer diameter86between about 10 mm and about 0.1 mm. In a preferred aspect, an outer member11can have an outer diameter86between about 0.5 mm to about 0.1 mm. In one aspect, an outer member11can have an inner diameter84between about 10 cm and about 0.01 mm. In an aspect, an outer member11can have an inner diameter84between about 10 mm and about 0.01 mm. In a preferred aspect, an outer member11can have an inner diameter84between about 5 mm and about 0.01 mm. In certain preferred aspects, an outer member11can have a length88and an inner diameter84configured to receive an inner member12as described below.

An outer member11can comprise a lumen17configured to receive an inner member12such that in an assembled configuration the inner member12can be co-axially disposed within the outer member11. As illustrated inFIGS.1,10,11and12, an inner member12can extend a length62between a proximal end14and a distal end16. As shown inFIGS.2,13and15, in one aspect an inner member12can comprise a lumen18. As illustrated inFIGS.3,4, and14, in an aspect, an inner member12have an outer diameter30,54and an inner diameter32,34,56,58. An inner member12can have any length62, any outer diameter30,54, and any inner diameter32,34,56,58. In one aspect, an inner member12can have a length62between about 20 cm and about 1 mm. In a preferred aspect, an inner member12can have a length62between about 20 mm to about 1 mm. In one aspect, an inner member12can have a length62that is equal to the length88of an outer member11. In an aspect, an inner member12can have a length62that is greater than a length88of an outer member11. In one aspect, an inner member12can have an outer diameter30,54between about 10 cm and about 0.01 mm. In an aspect, an inner member12can have an outer diameter30,54between about 10 mm and about 0.01 mm. In a preferred aspect, an inner member12can have an outer diameter30,54between about 0.5 mm to about 0.01 mm. In one aspect, an inner member12can have an inner diameter32,34,56,58between about 10 cm and about 0.01 mm. In an aspect, an inner member12can have an inner diameter between about 10 mm and about 0.01 mm. In a preferred aspect, an inner member12can have an inner diameter32,34,56,58between about 5 mm and about 0.01 mm. In a preferred aspect, an inner member12can have an outer diameter30,54that is configured to be receivable in a lumen17of an outer member11. In one aspect, an inner member12can have an outer diameter30,54that is less than the inner diameter84of the outer member11.

The inner member12can comprise a lumen18configured to receive a liner10(FIGS.1,2,5, and16) such that in an assembled configuration the liner10is co-axially disposed with the inner member12. The liner10can comprise a length82, an outer diameter72,74and an inner lumen64diameter. The liner10can have any length82, any inner lumen64diameter, and any outer diameter72,74. In an aspect, a liner can have a length82between about 10 cm and about 0.1 min. In an aspect, a liner10can have a length82between about 10 mm and about 0.1 mm. In a preferred aspect, a liner10can have a length82between about 5 mm and about 0.1 mm. The liner10can have a length82and an outer diameter72,74such that the liner10can be configured to be entirely received within a lumen18of an inner member12. The liner10can have a length82that is substantially the same as the length62of the inner member12. The liner10can have a length82that is less than the length62of the inner member12such that when the liner10is inserted into the inner member12(as described in detail below) the liner10does not contact a cutting surface50of the inner member12and is not exposed by a cutting window49of outer member11.

The liner10can have a length82equal to or greater than a length of a flexible portion24(such as described in more detail below) of an inner member12of a curved blade101. In an aspect, a liner10can have an outer diameter72,74between about 10 cm and about 0.01 mm. In an aspect, a liner10can have an outer diameter72,74between about 10 mm and about 0.01 mm. In a preferred aspect, a liner10can have an outer diameter72,74between about 0.5 mm to about 0.01 mm. In an aspect, a liner10can have an inner diameter or lumen64diameter between about 10 cm and about 0.01 mm. In an aspect, a liner10can have a lumen64diameter between about 10 mm and about 0.01 mm. In a preferred aspect, a liner10can have a lumen64diameter between about 5 mm and about 0.01 mm.

An inner member12can have an outer diameter30,54and an inner diameter32,34,56,58. As illustrated inFIGS.2,3,4, and14, the inner member12can have a larger inner diameter32,34,56than an outer diameter72,74of a liner10. For example, an inner member12can have a larger inner diameter32,34,56than an outer diameter72,74of the liner10such as allowing for insertion of the liner10within the inner member12. Portions of each of the liner10, inner member12, and outer member11can comprise generally tubular structures configured such that the liner10can be disposed within a lumen18of the inner member12, and the inner member12can be disposed within a lumen17of the outer member11, such as to provide a fully assembled configuration in which the liner10, the inner member12, and the outer member11can be co-axially disposed relative to one another as illustrated inFIG.1B. In a fully assembled configuration, a lumen64of the liner10can cooperate with a lumen18of the inner member12such as to provide a fluid passage through the curved blade101.

As shown inFIGS.1,2,10,11, and12, a curved blade101can comprise at least one rigid portion19,20,21,22, and at least one flexible portion such as23or24. A flexible portion can be radially, symmetrically bendable about a longitudinal axis A of the curved blade101. The flexible portion23or24can be bent in any direction relative to the longitudinal axis (e.g., up, down, left, right, and in any and all directions in between). The flexible portion23or24can be bent to any degree relative to the longitudinal axis A, e.g., between 0° and 180° relative to the longitudinal axis. A rigid portion can be rigid or inflexible or can have a flexibility that is less than the flexibility of a flexible portion of the curved blade101. In an example in which a curved blade101has two or more flexible portions23,24, each one of the flexible portions23,24can have a flexibility that is the same as or that is different from the flexibility of the other flexible portions. In an example, a curved blade101can have two or more flexible portions, each one of the flexible portions can flex independently of the other flexible portions. InFIGS.1,4,10,12and16, a rigid portion19,20,21,22can be connected to a flexible portion23,24of the curved blade101. The rigid portion21,22can comprise a blade, serrations, teeth, burr, or other cutting elements. An outer member11can comprise a rigid portion19such as adjacent to a proximal end13of the outer member11. An outer member11can comprise a rigid portion21such as adjacent to the distal end15of the outer member11. InFIGS.6and7, an outer member11can comprise a rigid portion19,21that can extend the entire length of the outer member11between the proximal end13and the distal end15, such that the outer member11does not have a flexible portion. An inner member12can comprise a rigid portion20adjacent to the proximal end14of the inner member12. The inner member12can comprise a rigid portion22adjacent to the distal end16of the inner member12. A first rigid portion19,20adjacent to a proximal end13,14of the curved blade101can extend distally toward a second rigid portion21,22adjacent to the distal end15,16of the curved blade101that can include a rigid portion21,22. A rigid portion21of an outer member11can comprise a cutting window49. A rigid portion22of an inner member12can comprise a cutting surface50. A rigid portion19,20,21,22of a curved blade101can be formed of a rigid or in-flexible material or a material having less flexibility than a flexible portion23,24of the curved blade101. A rigid portion19,20,21,22of a curved blade101can comprise a metal, a polymer, a ceramic, a carbon allotrope, e.g., graphene, or a combination of these.

InFIGS.2,3,4and14, a lumen18of the inner member12can comprise one or a plurality of inner diameters32,34,56,58. An inner member12can comprise a wall28,52having one or a plurality of thicknesses36A,36B,60A,60B. A plurality of inner diameters32,34,56,58or a plurality of wall thicknesses36A,36B,60A,60B can form, or provide a location for forming, a detent or stop38configured to engage a locking feature78of a liner10, such as described in detail below. A change in the inner diameter of a rigid portion20,22and/or a change in wall thickness of a rigid portion20,22can form, or provide a location or predetermined position for receiving a liner10within the lumen18of the inner member12. In one aspect, an inner diameter32,34,56,58of an inner member12can be between about 0.001 mm and about 10 mm. In a preferred aspect, an inner diameter32,34,56,58can be between about 0.001 mm and about 0.1 mm. In an aspect, a wall thickness36A,36B,60A,60B of an inner member12can be between about 0.001 mm and about 10 mm. In a preferred aspect, a wall thickness36A,36B,60A,60B of an inner member12can be between about 0.001 mm and about 1 mm. The inner member12can comprise a rigid portion20,22having an outer wall28A,52A and an outer diameter30,54. An inner wall28B,52B of the rigid portion20,22can define the lumen18. The lumen18can have a first inner diameter32,56. The lumen18can have a second inner diameter34,58. A rigid portion20,22can have a first inner diameter32,56and a second inner diameter34,58different from the first inner diameter32,56. An inner wall28B,52B of the rigid portion20,22can define a lumen18having a first inner diameter32,56adjacent to a proximal end40,46of the at least one rigid portion20,22. An inner wall28B,52B of the rigid portion20,22can define a lumen18having a second inner diameter34,58adjacent to a distal end42,48of the rigid portion20,22. The second inner diameter34,58can be different from the first inner diameter34,56. For example, a second inner diameter34of the rigid portion20can be greater than a first inner diameter32of the rigid portion20. Or, for example, a second inner diameter58of the rigid portion22can be less than a first inner diameter56of the rigid portion22.

An inner wall28B,52B of a rigid portion20,22of a curved blade101can form or include a detent or stop38configured to retain a liner10within the lumen18of the inner member12. A stop38can be formed when an inner diameter32,34,56,58of the inner member12is less than an outer diameter72,74of the liner10. A stop38can be formed in a region where there is friction between the inner wall28B,52B of the inner member12and a liner wall70,76. A stop38can be disposed at a transition in the inner diameter32,34,56,58of the inner member12. The stop38can comprise a transition in the inner diameter32,34,56,58of the inner member12. The stop38can comprise a transition between a first inner diameter32,56and a second inner diameter34,58of the inner member12. The stop38can be disposed at a transition in a thickness of an inner wall28B,52B. The stop38can comprise a transition in the thickness36A,36B,60A,60B of the inner wall28B,52B. The stop38can comprise a transition between the first thickness36A,60A of the inner wall28B,52B and the second thickness36B,60B of the inner wall28B,52B that is different from the first thickness. The stop38can comprise a transition between the first thickness36A,60A of the inner wall28B,52B and the second thickness36B,60B of the inner wall28B,52B that is less than the first thickness36A,60A. The stop38can comprise a transition between the first thickness36A,60A of the inner wall28B,52B and the second thickness36B,60B of the inner wall28B,52B that is greater than the first thickness36A,60A.

The stop38can be disposed adjacent to a distal end42,48of a rigid portion20,22. The stop38can be disposed adjacent to a proximal end40,46of a rigid portion20,22. The stop38can comprise one or more projections extending from the inner wall28B,52B. The stop38can comprise one or more apertures or recesses formed in the inner wall28B,52B. The stop38can extend around all or a portion of the circumference of the inner wall28B,52B. The stop38can be disposed at one or a plurality of discrete locations around the circumference or other periphery of the inner wall28B,52B. The stop38can comprise an annular ledge or abutment formed by the inner wall28B,52B of the rigid portion20,22. The stop38can comprise an annular ledge or abutment formed around all or only a portion of the circumference or other periphery of the inner wall28B,52B. The stop38can be configured to limit movement of a liner10toward a proximal end40,46of the rigid portion20,22. The stop38can be configured to limit movement of a liner10toward a distal end42,48of the rigid portion20,22.

A rigid portion21,22of a curved blade101can comprise a rigid portion formed of a rigid or a non-flexible material or a material having less flexibility than a flexible portion23,24of the curved blade101. A rigid portion21,22can comprise a metal, a polymer, a ceramic, a carbon allotrope, e.g., graphene, or a combination of these. As shown inFIGS.4and14, a rigid portion21can comprise a cutting window49. A rigid portion22can comprise one or more cutting surfaces50, such as a cutting edge or blade, serrations, burr or teeth. A cutting window49can be disposed adjacent to a distal end48of an inner member12. A cutting surface50of the rigid portion22can be disposed adjacent to a distal end48of an inner member12. The cutting window49and the cutting surface50can be configured to be aligned with one another when the inner member12is assembled with the outer member11.

A curved blade101can comprise at least one flexible portion23,24disposed adjacent to at least on rigid portion19,20,21,22. The flexible portion24of the inner member12can have a length90and can have an inner diameter92that cooperates with the inner diameter32,34,56,58of the at least one rigid portion20,22to define the lumen18of the inner member12. The inner diameter92of the flexible portion24can be greater than the inner diameter32,34,56,58of the at least one rigid portion20,22. The inner diameter92of the flexible portion24can be equal to, or essentially equal to, an inner diameter32,34,56,58of the at least one rigid portion20,22. A flexible portion23,24can be disposed adjacent to a first rigid portion19,20and a second rigid portion21,22. The flexible portion23,24can be disposed between a first rigid portion19,20and a second rigid portion21,22. As shown inFIGS.1,2,10and12, a flexible portion23,24of the curved blade101can comprise a flexible material26such as can be configured to impart flexibility to the flexible portion23,24. The flexible material26can comprise one or more strips of a flexible material. The flexible material26can comprise one or more strips wound or wrapped around an axis A of the inner member12. In an example in which the outer member11has a flexible portion23, the flexible material26can comprise one or more strips of a flexible material wrapped around an axis A of the outer member11. The one or more strips of flexible material26can be wound in a helical or spiral fashion around the axis A. The flexible material26can comprise a first strip of flexible material and a second strip of flexible material, the first strip wound or wrapped around the axis A of the inner member12in a first direction D1, and the second strip wound or wrapped over the first strip of flexible material26and around the axis A in a second direction D2opposite the first direction D1. The flexible material26can comprise a first strip of flexible material26, a second strip of flexible material26, and a third strip of flexible material25,26, the first strip of flexible material wound or wrapped around the axis A of the inner member12in a first direction D1, the second strip wound or wrapped over the first strip and around the axis A in a second direction D2opposite the first direction, and the third strip wound or wrapped over the second strip and around the axis A in the first direction D1. The flexible material26can comprise a plurality of strips of flexible material26that can be braided or interlocked with one another such as to form a flexible portion23,24of a curved blade101. As shown inFIGS.1,2,10and12, the flexible portion23,24can overlap the at least one rigid portion19,20,21,22. The flexible portion23,24can overlap a first rigid portion19,20. The flexible portion23,24can overlap a second rigid portion. The flexible portion23,24can be affixed to the at least one rigid portion19,20,21,22. The flexible portion23,24can be affixed to a first rigid portion19,20. The flexible portion23,24can be affixed to a second rigid portion21,22. The flexible portion23,24can be fixed, such as by a weld, an adhesive, or a fastener, to the at least one rigid portion19,20,21,22. The flexible portion23,24can be affixed such as by a weld, an adhesive, or a fastener, to a first rigid portion19,20. The flexible portion23,24can be affixed, such as by a weld, an adhesive, or a fastener to a second rigid portion comprising a blade portion21,22.

InFIGS.1,2and4, a liner10of a curved blade101can comprise a liner wall70defining a lumen64, the liner wall70extending a length82between a liner proximal end66and a liner distal end68. The liner10can be formed of a natural polymer or a synthetic polymer (e.g., Polyolefin, Polyvinyl Chloride, Polyether Block Amide, Thermoplastic Polyurethane, etc.), a fabric, or a combination of any of these materials. The liner10can be formed of any material configured to flex or bend. The liner10can be configured to flex, such as in response to or in coordination with flexing or bending of a flexible portion23,24of the curved blade101. The liner wall70can comprise a first outer diameter72. The liner10can comprise a first outer diameter72and a second outer diameter74different from the first outer diameter72. The liner10can comprise a first outer diameter72adjacent to a liner proximal end66and a second outer diameter74adjacent to a liner distal end68. The second outer diameter74can be less than the first outer diameter72. A liner10can comprise a locking feature78configured to retain the liner10within a lumen18of the inner member12. The locking feature78can comprise a flared region in the wall70. The locking feature78can comprise a portion of the liner wall70having a first outer diameter72. The locking feature78can comprise a portion of a wall70having a first outer diameter72disposed adjacent to a liner proximal end74. The locking feature78can comprise one or more apertures or recesses formed in the liner wall70. The locking feature78can comprise a projection extending from the wall70. The locking feature78can comprise a flange. The locking feature78can extend around all or only a portion of the circumference of the liner wall70. The locking feature78can be disposed at one or a plurality of discrete locations around the circumference or other periphery of the liner wall70. A locking feature78can comprise a transition in the thickness80of the liner wall70. The locking feature78can comprise a transition between a first outer diameter72and a second outer diameter74of a liner wall70. A locking feature78can comprise a transition between a first thickness80A of a liner wall70and a second thickness80B of a liner wall70that is different from the first thickness80A. A liner wall second thickness80B can be less than the wall first thickness80A. The locking feature78can comprise an annular ledge, such as can be formed by or on the liner wall70. A locking feature78can comprise a liner end wall76. A locking feature78can comprise an end wall76adjacent to the distal end68of the liner10.

When at least one rigid portion20,22, and a flexible portion24are in an assembled configuration for the inner member12, as shown inFIGS.1,2,10,11, and16, a liner10can be inserted in a proximal to distal direction, through the lumen18of the inner member12. InFIG.1B, in a method of forming a curved blade101, a liner10can be inserted into an assembled inner member12such as by inserting a liner10distal end68into at least one rigid portion20,22of inner member12until the liner10engages an a stop38of the at least one rigid portion20,22. The liner10can be inserted into an assembled inner member12such as by inserting a liner10distal end68into the at least one rigid portion20, pushing the liner10through the at least one rigid portion20until a locking feature78of the liner10engages a stop38of the at least one rigid portion22. The liner10can be inserted into an assembled inner member12comprising at least one rigid portion20adjacent to a proximal end14of inner member12, until a locking feature78of the liner10engages a stop38of the at least one rigid portion20. The liner10can be inserted into an assembled inner member12comprising at least one rigid portion22adjacent to a distal end16of inner member12until a locking feature78of the liner10engages a stop38of an interior wall28B,52B of the at least one rigid portion20,22. The liner10can be inserted into the inner member12until the locking feature78engages an interior wall28B,52B of the inner member12. The locking feature78can comprise an end wall76of a liner10and the liner10can be inserted until the liner end wall76engages an interior wall28B,52B of the inner member12. A locking feature78can comprise an end wall76of a liner10and the liner10can be inserted until the liner end wall76engages an interior wall52B adjacent to a distal end16of the inner member12. The liner10can be inserted into an inner member12until the liner10is disposed at a predetermined position within the inner member12. The predetermined position can be a position in which the locking feature78or end wall76of the liner10does not engage a stop38or an interior wall28B,52B of the inner member12and the liner10and/or the inner member12can subjected to a temperature or pressure (as described below) to cause the locking feature78or end wall76of the liner10to engage a stop38or the interior wall28B,52B of the inner member12.

An inner member12can be inserted proximally to distally through a lumen17of the outer member12. An inner member12can be inserted into an outer member11after the liner10is inserted into the inner member12. An inner member12can be inserted into an outer member11before a liner10is inserted into the inner member12. The inner member12can be inserted into a lumen17of the outer member11by inserting the distal end16of the inner member12through the proximal end13of the outer member11, pushing the inner member12through the lumen17until the distal end16of the inner member12reaches the distal end15of the outer member11. The inner member12can be inserted into the lumen17of the outer member11until a rigid portion22at distal end16of the inner member12reaches a rigid portion21at the distal end15of the outer member11. An inner member12can be inserted into a lumen17of the outer member11until a cutting surface50of the inner member12is aligned with a cutting window49of the outer member11.

In a fully assembled configuration, a curved blade101can comprise a liner10within a lumen18of the inner member12. The liner10can be co-axial with an axis A of the inner member12of the curved blade101. The liner10can have a length82that can be equal to, or substantially equal to, a length62of an inner member of the curved blade101. The liner10can have a length82that is less than a length62of an inner member12of the curved blade101. A liner10can have a length82that is less than a length88of an outer member11of the curved blade101. The liner10can be disposed with the lumen18adjacent to a flexible portion23,24of the curved blade101. A liner10can be disposed adjacent to a flexible portion24of an inner member12of the curved blade101. The liner10can have a length82that is equal to or greater than a length90of the flexible portion24of the inner member12. The liner10can extend a length82such that the liner proximal end66is disposed adjacent to and/or overlaps a distal end42of the rigid portion20of inner member12of the curved blade101. The liner10can extend a length82such that the liner distal end76is adjacent to and/or can overlap a proximal end46of a rigid portion22of the inner member12of the curved blade101. The liner10can extend a length82such that a liner proximal end66overlaps a distal end42of a first rigid portion20of the inner member12. The liner10can extend a length82such that liner distal end68is adjacent to and/or can overlap a proximal end46of a second rigid portion22of the inner member12. The liner10can extend a length82such that a liner proximal end66overlaps a distal end42of a first rigid portion20and a liner distal end68overlaps a proximal end46of a second rigid portion22of an inner member12of a curved blade101. The liner10can extend a length82such that a first locking feature78can engage a stop38of a first rigid portion20and a liner second locking feature76,78can engage a stop38of a second rigid portion22of an inner member12.

The liner10can have a length82that can extend substantially the length62of the inner member12, but the length82can be such that it does not reach the cutting surface50of the inner member12and is not exposed by the cutting window49of the outer member13.

A method of forming a curved blade101can comprise sealing a lumen18of an inner member12of the curved blade101. The method of forming a curved blade101can comprise forming a seal S between a lumen18and a flexible portion24of an inner member12. InFIG.16, a liner10can be configured to provide a seal S to a lumen18of the curved blade101. The liner10can be configured to seal S a lumen18of an inner member12of a curved blade101. The liner10can be configured to form a seal S between liner wall70and a flexible portion24of an inner member12of a curved blade101. The liner10can be configured to form a seal S by causing a liner outer diameter72,74to expand to meet an inner diameter92of the flexible portion24of the inner member12of a curved blade101. The seal S can be imparted to an assembled combination of an inner member12comprising at least one rigid portion20,22and a flexible portion24, and a liner10, by subjecting the inner member12to a pressure. The seal S can be imparted by applying pressure in the form of a fluid F (gas or liquid) to the liner10and the lumen18of the inner member12of a curved blade101(either when separated from the outer member H or when assembled with the outer member11) and sealing the proximal end14and sealing the distal end16of the inner member12, e.g., by providing a cap or a cover for the proximal end14and/or the distal end16, or by wrapping, encasing or closing the proximal end14and/or the distal end16with a material configured to seal the proximal end14and/or the distal end16. The seal S can be imparted by applying a fluid F to the liner10and the lumen18of the inner member12of a curved blade101, sealing the proximal end14and sealing the distal end16of the inner member12, and subjecting the inner member12(either when separated from the outer member11or when assembled with the outer member11) and fluid F to a temperature above 25° C. The temperature above 25° C. can be a predetermined temperature. In an aspect, a temperature above 25° C. can be any temperature from about 50° C. to about 80° C. In a preferred aspect, a temperature above 25° C. can be any temperature from about 60° C. to about 70° C. In an aspect, a seal S can be imparted by applying a cooling temperature, e.g. a temperature below 45° C., to a liner10, inserting the cooled liner10into the assembled inner member12(either when the inner member12is separated from the outer member11or when the inner member12is assembled with the outer member11), and allowing the liner10to warm to a temperature such that the liner10outer diameter72,74expands to meet an inner diameter32,34,56,58,92the rigid portion20,22, and/or the flexible portion24of the inner member12. In an aspect, a cooling temperature can be any temperature from about 0° C. to about 45° C. In a preferred aspect, a cooling temperature can be any temperature from about 15° to about 25° C. In an aspect, the liner10is comprised of a material that will not revert to an original liner outer diameter after the foregoing manipulations of the liner10to form a seal S.

A method of performing a surgical procedure with a curved blade101, as shown inFIG.1B, can include inserting a surgical tool into a passage of a patient. The surgical tool can include a curved blade101comprising an inner member12and an outer member11each having a proximal end13,14and distal end15,16. The inner member12can include a cutting surface50adjacent to the distal end16and at least one flexible portion24disposed between the proximal end14and the distal end16. The outer member can include a cutting window49disposed adjacent to the distal end15and at least one flexible portion23disposed between the proximal end13and the distal end15. The inner member12can be received within the outer member11in a manner to align the cutting surface50of the inner member12with the cutting window49of the outer member11. A liner10, disposed within a lumen18of the inner member12, can have a proximal end66and a distal end68. A proximal end66of the liner can have a locking feature78engaged with a stop38adjacent to a proximal end14of the inner member12. A distal end of the liner10can have a locking feature76,78at a distal end68, the locking feature76,78engaged with a stop38adjacent to a distal end16of the inner member12. The method of performing a surgical procedure with a surgical tool comprising a curved blade101can include inserting the curved blade101into the passage of the patient and allowing an inner member12to rotate or oscillate with respect to the outer member11. The method of performing a surgical procedure with a surgical tool comprising a curved blade101can include removing the surgical tool from the passage of the patient.

In this document, terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may include the plural forms as well, unless the context clearly indicates otherwise. The terms “a” or “an” are also used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” in this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in this document, including in the following claims, the terms “including,” “comprising” and “having” are open-ended and inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.

Although the terms “first,” “second,” “third,” etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. Terms such as “first,” “second,” “third,” and other numerical terms used herein, including the following claims, do not imply a sequence or order unless clearly indicated by the context.

In this disclosure, relative terms, such as, for example, “about”, “generally”, or “substantially” are used to indicate a possible variation of ±10% in a stated numeric value or within ±10° of the numeric value.

The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.