SEALING AND STABILIZING DEVICE FOR USE WITH ENDOSCOPIC SHAVERS
20180199954 ยท 2018-07-19
Assignee
Inventors
- Christopher P. Dougherty (Rogers, AR, US)
- Gary R. Heisler (Brazoria, TX, US)
- Robert A. Van Wyk (St. Pete Beach, FL, US)
Cpc classification
A61B2017/0046
HUMAN NECESSITIES
A61B17/32002
HUMAN NECESSITIES
International classification
Abstract
Described herein is combination sealing and stabilizing collar component designed to both prevent the leakage of vacuum through the interface between an endoscopic shaver device and a powered handpiece that provides rotational motion thereto and stabilize the endoscopic shaver device when it is mounted onto the powered handpiece. The collar may be further coupled with a conventional cannula to prevent the leakage of intra-articular fluid when performing an arthroscopic procedure.
Claims
1. An endoscopic shaver assembly comprising: a. an elongate tubular outer member characterized by a distal end having an outer cutting aperture formed therein, a proximal end that includes an outer hub configured for removable mounting within a cavity of an endoscopic shaver handpiece, and an elongate central lumen extending between said proximal and distal ends that defines the longitudinal axis of the shaver assembly, wherein the distal portion of said outer hub includes a first set of threads, further wherein distal axial movement of said outer member relative to said endoscopic shaver handpiece is precluded by means of an annular locking collet disposed about the outer periphery of said outer hub, further wherein said annular locking collet defines a gap between the outer periphery of said outer hub and an inner periphery of said collet; b. an elongate tubular inner member characterized by a distal end having an inner cutting aperture formed therein, a proximal end that includes an inner hub configured for receiving torque from said endoscopic shaver handpiece and a proximal port for transmitting suction from said endoscopic shaver handpiece to said inner cutting aperture via an elongate central lumen that extends between said proximal and distal ends of said inner member, wherein said inner member is slidably received within the central lumen of said outer member and axially extended such that said inner and outer cutting apertures align; and c. a combination sealing and stabilizing collar having a proximal end, a distal end, a central opening extending between said proximal and distal ends, a circumferential rim extending radially from said central opening characterized by proximally and distal facing surfaces, and a second set of threads complementary to and configured to engage with said first said of threads on said outer hub, wherein said combination sealing and stabilizing collar is mounted over the elongate outer member and positioned against the distal end of said outer hub, further wherein engaging said first and second sets of threads causes said proximal facing surface of said circumferential rim to be firmly seated against said annular locking collet and thereby seal the gap disposed between said outer hub and said annular locking collet and preclude lateral movement of outer member.
2. The endoscopic shaver assembly according to claim 1, wherein said first set of thread is disposed about the interior surface of a proximally extending recess provided the distal end of said outer hub and said complementary second set of threads is disposed about the exterior surface of a proximally facing cylindrical projection that extends from said central opening.
3. The endoscopic shaver assembly according to claim 1, wherein said first set of thread is disposed about the exterior surface of a distally facing cylindrical projection provided on the distal side of said outer hub and said complementary second set of threads is disposed about the interior surface of said central opening.
4. The endoscopic shaver assembly according to claim 1, wherein said distal facing surface of comprises one of more radially extending raised flanges that facilitate the threading of said first set of threads to said second set of threads.
5. The endoscopic shaver assembly according to claim 1, wherein said assembly further comprises a cannulated access device characterized by a central lumen into which said outer member is slidably received, further wherein the distal end of said combination sealing and stabilizing collar threadedly connected to the proximal end of said cannulated access device.
6. The endoscopic shaver assembly according to claim 5, wherein the central lumen of said cannulated access device comprises one or more sealing elements.
7. The endoscopic shaver assembly according to claim 6, wherein at least of one of said one or more sealing elements comprises a flap valve.
8. The endoscopic shaver assembly according to claim 5, wherein said cannulated access device further comprises a tubular inflow/outflow channel normal to and in fluid communication with the central lumen of said cannulated access device.
9. The endoscopic shaver assembly according to claim 5, wherein the exterior surface of the distal end of said cannulated access device is provided with a spiral thread that facilitates atraumatic tissue insertion.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0012] 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:
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0053] 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: [0054] U.S. Pat. No. 9,486,232 issued Jan. 1, 2016 to Heisler et al.; [0055] U.S. Pat. No. 7,666,200 issued Feb. 23, 2010; U.S. Pat. No. 8,088,135 issued Jan. 3, 2012; U.S. Pat. No. 8,177,803 issued May 15, 2012; and U.S. Pat. No. 8,313,502 issued Nov. 20, 2012 to Heisler; [0056] U.S. application Ser. No. 14/470,422 filed Aug. 27, 2014 and published as US 2015/0065808 to Van Wyk et al.; and [0057] U.S. application Ser. No. 15/288,509 filed Oct. 7, 2016 and published as US 2017/100136 to Dougherty et al.
Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the preferred methods, devices, and materials are now described. However, before the present materials and methods are described, it is to be understood that the present invention is not limited to the particular sizes, shapes, dimensions, materials, methodologies, protocols, etc. described herein, as these may vary in accordance with routine experimentation and optimization. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.
[0058] 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.
[0059] In the context of the present invention, the following definitions apply:
[0060] 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.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] 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.
EXAMPLES
[0074] Referring to
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[0076] Tissue is resected by shaver 100 in the following manner:
[0077] 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.
[0078] Referring again to
[0079] 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.
[0080] 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.
[0081] 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.
[0082] In a first illustrative embodiment depicted in
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[0084] An alternate embodiment, the exploded assembly of which is depicted in
[0085] 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.
[0086] Assembled sealing/stabilizing collar 400 is depicted in
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[0089] 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
[0090] Sealing/stabilizing collar 600 is used in the same manner as sealing/stabilizing collar 300, and as depicted in
[0091] 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
INDUSTRIAL APPLICABILITY
[0092] 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.
[0093] 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.
[0094] 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.