The present invention relates generally to the field of endoscopic and arthroscopic surgery, more particularly to a sealing and stabilizing devices for use with powered endoscopic shaver assemblies designed for such surgeries. In a particularly preferred embodiment, the present invention relates to a collar component of an endoscopic shaver assembly that is designed to that both prevent the leakage of vacuum through the interface between an endoscopic shaver device and a powered handpiece that provides rotational motion thereto and stabilizes the endoscopic shaver device when it is mounted onto the powered handpiece. The collar component may additionally be coupled to a conventional cannula to prevent the leakage of intra-articular fluid when performing an arthroscopic procedure.
Endoscopic shavers are well known in the art. The construction and use of illustrative examples of such a device is described in U.S. Pat. No. 4,203,444 to Bonnell et al. and U.S. Pat. No. 4,646,738 to Trott, as well as U.S. Pat. Nos. 7,66,200, 8,313,502 and 9,486,232 to Heisler et al., among others.
Endoscopic shavers (also referred to as “arthroscopic” shavers) may be designed for single-use or as reusable devices that may be mounted onto a reusable handpiece that powers the shaver blades. A typical handpiece is configured to provide suction to the shaver along with rotational motion. Critically, adequate clearance must be provided between the mounting element (often referred to as an “outer hub”) of the shaver and the accepting orifice of the handpiece. The gap afforded by this clearance can provide a path for vacuum leakage. As such leakage decreases the vacuum applied to the shaver and thereby reduces its efficiency, there is strong desire in the arts to minimize and/or avoid it entirely. Additionally, this gap can cause the shaver to be inadequately mounted in the handpiece and thus allow the inner member of the shaver device to deflect from the preferred linear configuration or otherwise move around during use. Accordingly, there is a clear need in the art to strengthen and securely fix the connection between the shaver device and the handpiece. Thus, a primary objective of the present invention is to resolve the problems of leakage and deflection and thereby provide a more efficient, effective endoscopic shaver assembly.
The conventional endoscopic shaver assembly is comprised of an elongated inner member axially slidable and rotatably situated within an elongated stationary outer member, wherein both inner and outer members have coordinating hubs at their respective proximal ends and cutting apertures which cooperate to resect tissue during endoscopic surgical procedures at their respective distal ends. The distal end of the outer hub of a shaver blade typically incorporates a means for removably mounting a cannula thereto. For instance, the Universal Cannula products by Conmed, Incorporated (Utica, N.Y.) may be mounted to Conmed's Ultra and Sterling shaver blades, along with others of their manufacture. The mounting means is generally comprised of complementary internal or external threaded portions on the cannula and outer hub. Collar devices of the present invention removably mount to the distal portion of the outer hub of a shaver blade in the manner of prior art cannulas. However, unlike prior art cannulas, preferred embodiments of the present invention have a flange that blocks flow through the gap between the shaver's outer hub and the shaver handpiece, thereby increasing the efficiency of the shaver by decreasing the vacuum loss through the gap. Additionally, the collar components of the present invention stabilize the shaver so as to reduce deflection of the shaver distal portion during use.
Thus, in one preferred embodiment, the present invention provides a combination sealing and stabilizing device adapted for use with an endoscopic shaver that includes:
In a particularly preferred embodiment, the combination sealing and stabilizing device takes the form of a collar having a proximal end, a distal end, a central opening extending between the proximal and distal ends, a circumferential rim extending radially from the central opening characterized by proximally and distal facing surfaces, and a second set of threads complementary to and configured to engage with the first said of threads on the outer hub, wherein the combination sealing and stabilizing collar is mounted over the elongate outer member and positioned against the distal end of the outer hub, further wherein engaging the first and second sets of threads causes the proximal facing surface of the circumferential rim to be firmly seated against the annular locking collet and thereby seal the gap disposed between the outer hub and the annular locking collet and preclude lateral movement of outer member.
The sealing and stabilizing collar, the endoscopic shaver, and the shaver handpiece may take the form of a kit or assembly that may optionally further include a cannulated access device such as conventional in the art.
These and other aspects are accomplished in the invention herein described, directed to sealing and stabilizing mechanisms for use with powered endoscopic shaver assemblies. Further objects and features of the invention will become more fully apparent when the following detailed description is read in conjunction with the accompanying figures and examples. However, it is to be understood that both the foregoing summary of the invention and the following detailed description are of a preferred embodiment, and not restrictive of the invention or other alternate embodiments of the invention. In particular, while the invention is described herein with reference to a number of specific embodiments, it will be appreciated that the description is illustrative of the invention and is not constructed as limiting of the invention.
Various aspects and applications of the present invention will become apparent to the skilled artisan upon consideration of the brief description of figures and the detailed description of the present invention and its preferred embodiments that follows:
Aspects of the present invention relate to, overlap with and/or find utility in conjunction with aspects described in the following related patents and patent applications, the entire contents of which are hereby incorporated in their entirety:
Accordingly, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. However, in case of conflict, the present specification, including definitions below, will control.
In the context of the present invention, the following definitions apply:
The words “a”, “an” and “the” as used herein mean “at least one” unless otherwise specifically indicated. Thus, for example, reference to an “opening” is a reference to one or more openings and equivalents thereof known to those skilled in the art, and so forth.
The term “proximal” as used herein refers to that end or portion which is situated closest to the user of the device, farthest away from the target surgical site. In the context of the present invention, the proximal face of the collar device of the present invention configured for use with an endoscopic shaver assembly may include one or more threaded components for mounting the collar to the distal end of an outer hub component and providing a fluid tight seal to the aspiration lumen therewithin.
The term “distal” as used herein refers to that end or portion situated farthest away from the user of the device, closest to the target surgical site. In the context of the present invention, the distal face of the collar of the present invention is configured to coordinate with a valved introduction cannula.
In the context of the present invention, the terms “cannula” and “cannulated” are used to generically refer to the family of rigid or flexible, typically elongate lumened surgical instruments that facilitate access across tissue to an internally located surgery site.
The terms “tube” and “tubular” are interchangeably used herein to refer to a generally round, long, hollow component having at least one central opening often referred to as a “lumen”.
The terms “lengthwise” and “axial” as used interchangeably herein to refer to the direction relating to or parallel with the longitudinal axis of a device. The term “transverse” as used herein refers to the direction lying or extending across or perpendicular to the longitudinal axis of a device.
The term “rotational” as used herein refers to the revolutionary movement about the center point or longitudinal axis of the device. In the context of the present invention, rotation of the elongated inner tubular member relative to the elongated outer tubular member, which typically is held in a stationary position, results in relative rotation of their respective cutting apertures which coordinate to resect target tissue within the surgical site of interest.
The term “lateral” pertains to the side and, as used herein, refers to motion, movement, or materials that are situated at, proceeding from, or directed to a side of a device.
The term “medial” pertains to the middle, and as used herein, refers to motion, movement or materials that are situated in the middle, in particular situated near the median plane or the midline of the device or subset component thereof.
The term “radial” is used herein to refer to characterize movement inward and outward from a central point or shaft, e.g., thrusts radial to the center of rotation.
The present invention contemplates the use of alternative cooperating elements, in particular cooperating elements of the collar device and the outer hub of the endoscopic shaver that coordinate to ensure fluid tight attachment of the collar to the endoscopic shaver assembly. While the invention is described herein below with respect to mating screw threads, other cooperating elements are contemplated, examples of which include, but are not limited to, worm gears, worm wheels, pneumatic devices, hydraulic mechanisms, magnetic assemblies, ratchet-and-pawl assemblies, and push-pull connectors.
In the context of the present invention, reference is made to various lock-and-key type mating mechanisms that serve to establish and secure the axial and rotational arrangement of various concentric or relatively slidable device components. It will be readily understood by the skilled artisan that the position of the respective coordinating elements (e.g., recessed slots and grooves that mate with assorted projecting protrusions, protuberances, tabs and splines) may be exchanged and/or reversed as needed.
The instant invention has both human medical and veterinary applications. Accordingly, the terms “subject” and “patient” are used interchangeably herein to refer to the person or animal being treated or examined. Exemplary animals include house pets, farm animals, and zoo animals. In a preferred embodiment, the subject is a mammal, more preferably a human.
Hereinafter, the present invention is described in more detail by reference to the Figures and Examples. However, the following materials, methods, figures, and examples only illustrate aspects of the invention and are in no way intended to limit the scope of the present invention. For example, while the present invention makes specific reference to arthroscopic procedures, it is readily apparent that the teachings of the present invention may be applied to other minimally invasive procedures and thus are not limited to arthroscopic uses alone. As such, methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention.
Referring to
Tissue is resected by shaver 100 in the following manner:
Inner assembly 30 of endoscopic shaver 100 is rotatably positioned within outer assembly 10. Handpiece 200 imparts a rotational (generally oscillating) motion to inner assembly 30 through inner hub 36 which engages with a drive mechanism (now shown) within shaver handpiece body 202. When aperture 34 of inner assembly 30 comes into alignment with aperture 14 of outer assembly 10, tissue is drawn into the aligned apertures by suction supplied thereto as previously described. As aperture 34 rotates past aperture 10, tissue trapped between lateral edges of the apertures is resected, the edges of apertures 34 and 10 being configured for that purpose. The resected tissue is aspirated from the site in the manner previously herein described. The efficiency of shaver 100 is strongly affected by the level of vacuum which draws tissue into aligned apertures 14 and 34. A decrease in the vacuum at the apertures results in less tissue being drawn into the aligned apertures and therefore less tissue resection.
Referring again to
In an attempt to minimize vacuum leakage through gap 212, various sealing methods have been contemplated by the prior art. For example, in some cases an elastomeric seal is incorporated in handpiece body 202 or collet 206. Because handpiece 200 is typically sterilized in an autoclave between uses, polymeric seals that are part of handpiece 200 may, over time, lose their elasticity and become ineffective at preventing vacuum leakage. In other cases, an elastomeric seal is positioned on outer hub 16. In such cases, the effectiveness of the seal is affected by the size of hub 16 and thus the effectiveness of the seal varies accordingly.
In addition to contributing to vacuum loss, gap 212 also results in shaver 100 not rigidly being held in handpiece 200. For example, while the axial position of shaver 100 is determined by collet 206, the distal end of shaver 100 may deflect from its ideal axial position during use, with the degree of deflection being determined by the size of gap 212. This deflection may cause the distal end of shaver 100 to wobble during use.
The present invention addresses the problems of leakage and deflection by providing a combination sealing and stabilizing collar component that prevents vacuum leakage through gap 212, and makes rigid the fixation of shaver 100 in handpiece 200.
In a first illustrative embodiment depicted in
An alternate embodiment, the exploded assembly of which is depicted in
Distal element 410 has an elongate tubular distal portion 412 with a distal end 414. As depicted herein, distal element 412 has threads formed adjacent to distal end 414. In other embodiments, threads 416 extend the entire length of distal portion 412. In still other embodiments threads 416 are not present. Proximal portion 420 of distal element 410 with proximal cylindrical recess 424 functions as a housing in which distal sealing element 440 and proximal sealing element 442 are positioned in the assembled device. Tubular inflow/outflow element 430 provides a fluid flow path to lumen 418 distal to sealing elements 440 and 442. Tubular inflow/outflow element with lumen 434 has formed at its distal end flange 432 configured for the removable mounting thereto of a Luer connector or Luer cap. Distal sealing element 440 is located and maintained in its position by groove 441 in the distal face of sealing element 440 coupling with annular rib 422 formed in the distal wall of proximal cylindrical recess 422 of distal element 410. Proximal element 450 is like sealing/stabilizing collar 300 in all aspects of form and function except as specifically hereafter described. The distal portion of proximal element 450 is configured for irremovable attachment to the proximal end of distal element 410. Distal facing annular rib 460 together with complementary groove 444 formed in the proximal face of proximal sealing element 442 locate and maintain the position of proximal sealing element 442 during assembly and use.
Assembled sealing/stabilizing collar 400 is depicted in
Shaver 500 may be stabilized relative to handpiece 200 in which it is mounted for use, and vacuum leakage prevented by mounting thereto alternate embodiment sealing/stabilizing collar 600 depicted in
Sealing/stabilizing collar 600 is used in the same manner as sealing/stabilizing collar 300, and as depicted in
It will be understood that sealing/stabilizing collar 600 can be modified in the same manner as sealing/stabilizing collar 300 with the addition of an elongate distal tubular member and sealing elements to create a functionally equivalent device to collar 400 depicted in
As noted previously, conventional endoscopic shavers tend to suffer from vacuum leakage which, in turn, undermines the efficiency of the device. In addition, the proximal connection between such devices and an associated powered handpiece has a tendency to be insufficiently rigid, whereby the longitudinal axis of the shaver device is permitted to flex and deflect from the desired linear position. Embodiments of the present invention address one or more of these disadvantages by providing a combination sealing and stabilizing collar component that both prevents vacuum leakage and ensures a rigid linear construction that may optionally be coupled to a conventional cannula for preventing intra-articular fluid leakage.
The disclosure of each publication, patent or patent application mentioned in this specification is specifically incorporated by reference herein in its entirety. However, nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention.
The invention has been illustrated by reference to specific examples and preferred embodiments. However, it should be understood that the invention is intended not to be limited by the foregoing description, but to be defined by the appended claims and their equivalents.
This application claims the benefit of U.S. Provisional Application Ser. No. 62/499,155 filed Jan. 17, 2017, the contents of which are hereby incorporated by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
62499155 | Jan 2017 | US |