Anoscope
An insertion device for use during surgical procedure to enlarge an opening in a patient's tissue to facilitate access to an internal treatment site with a surgical instrument. The insertion device includes an anoscope including a flange, and an elongate body having proximal and distal ends extending distally from the flange along a longitudinal axis. The anoscope may include a configuration that is asymmetrical about a plane extending along the longitudinal axis that bisects the flange.
This application is a divisional of U.S. patent application Ser. No. 12/880,215 filed Sep. 13, 2010, which claims benefit of and priority to U.S. Provisional Application No. 61/249,652 filed Oct. 8, 2009, and the disclosures of each of the above-identified applications are hereby incorporated by reference in their entirety.
BACKGROUND1. Technical Field
The present disclosure relates to an insertion device that is adapted for positioning within an opening in tissue to facilitate access to an internal treatment site with a surgical instrument. More particularly, the present disclosure relates to an anoscope kit for use with a surgical fastener applying apparatus.
2. Background of Related Art
A medical device used in the dilation and/or inspection of an internal treatment site, e.g., a treatment site within a patient's anus, rectum, and/or colon, is often referred to as an anoscope. Anoscopes generally comprise a hollow body that is configured and dimensioned for insertion into an opening in the patient's tissue; either an opening that is natural and pre-existing, e.g., the patient's anus, or an opening that is formed by a clinician, e.g., an incision. The hollow body of the anoscope will generally include structure that is configured and dimensioned to dilate, and cover, the opening in the patient's tissue, as well as structure at the distal end thereof that is configured and dimensioned to accommodate the target tissue, e.g., hemorrhoidal tissue, such as a gap, notch, or slot.
After positioning the anoscope within the opening in the patient's tissue, the interior of the hollow body provides a passage through which the clinician can inspect the internal treatment site, and perform the surgical procedure. For example, anoscopes are particularly useful in the inspection and treatment of hemorrhoidal tissue, as well as tissue positioned adjacent thereto, e.g., mucosal tissue, during hemorrhoid procedures. During these procedures, the clinician will usually excise the target tissue, and thereafter suture the treated area.
An anoscope including structure that is configured and dimensioned to increase maneuverability and manipulation of the anoscope would be desirable in the interests of allowing a clinician to more easily access the tissue that is the subject of the surgical procedure.
SUMMARYIn one aspect of the present disclosure, an insertion device is disclosed for use during a surgical procedure to enlarge an opening in a patient's tissue to facilitate access to an internal treatment site with a surgical instrument. The disclosed insertion device includes an anoscope with a flange, and an elongate body having proximal and distal ends that extends distally from the flange along a longitudinal axis. In one embodiment, the anoscope includes a configuration that is asymmetrical about a plane extending along the longitudinal axis that bisects the flange.
It is envisioned that the body of the anoscope may include a first opening spaced longitudinally from a second opening, wherein the first and second openings are aligned along the longitudinal axis.
The flange can include first and second circumferentially spaced ends defining a gap therebetween that is configured and dimensioned to receive tissue. In one embodiment, the anoscope includes at least one wing that extends outwardly from the flange relative to the longitudinal axis. For example, the anoscope may include a single wing positioned either adjacent one of the ends of the flange, or alternatively, between the ends of the flange. In another embodiment, rather than just a single wing, the anoscope may include a first wing and a second wing. In this embodiment, it is envisioned that the first wing may extend outwardly from the flange a first distance, whereas the second wing may extend outwardly from the flange a second, greater distance. To enhance maneuverability of the anoscope, the wing(s) may include a lip extending along a periphery creating a surface adjacent the lip to facilitate maneuverability.
The presently disclosed insertion device may also include a dilator that is configured and dimensioned for positioning within the body of the anoscope.
The insertion device may include a port defining a longitudinal opening therethrough that is configured and dimensioned to receive the anoscope, wherein the port itself is configured and dimensioned for positioning within the opening in the tissue. It is envisioned that the port may include a pair of wings extending outwardly therefrom along an axis that is transverse in relation to the longitudinal axis such that the longitudinal axis and the transverse axis define an acute angle therebetween. For example, the angle defined between the longitudinal axis and the transverse axis may be approximately equal to 55°.
The present disclosure also provides in another aspect, an insertion device that includes an anoscope with a flange, and an elongate body having proximal and distal ends that extends distally from the flange along a longitudinal axis. The anoscope includes a configuration that is symmetrical about a plane extending along the longitudinal axis that bisects the flange. The anoscope includes a pair of wings that extend outwardly from the flange relative to the longitudinal axis and curve outwardly away from the distal end, wherein each of the wings includes a lip extending in a proximal direction that is positioned along a peripheral edge thereof.
The distal end of the anoscope preferably includes a closed distal tip that is configured and dimensioned to facilitate atraumatic advancement and/or rotation of the anoscope.
In yet another aspect of the present disclosure, an insertion device is disclosed including a port defining a longitudinal opening therethrough that is configured and dimensioned for positioning within the opening in the tissue, an anoscope that is configured and dimensioned for positioning within the longitudinal opening of the port, and a dilator that is configured and dimensioned for positioning within the body of the anoscope. The anoscope includes a flange, and an elongate body extending distally from the flange along a longitudinal axis. The anoscope has a configuration that is asymmetrical about a plane extending along the longitudinal axis that bisects the flange.
It is envisioned that the anoscope may also include at least one wing extending outwardly from the flange relative to the longitudinal axis.
The port of the insertion device may include a pair of wings that extend outwardly therefrom, wherein at least one of the wings includes an aperture that is configured and dimensioned to receive a flexible member such as a suture to facilitate attachment of the port to the patient's tissue. It is envisioned that the wings may extend outwardly along an axis that is transverse in relation to the longitudinal axis such that the longitudinal axis and the transverse axis define an acute angle therebetween.
These and other features of the presently disclosed insertion device will become more readily apparent to those skilled in the art through reference to the detailed description of various embodiments of the present disclosure that follows.
Various embodiments of the present disclosure are described herein below with reference to the drawings, wherein:
The presently disclosed insertion device will now be described in detail with reference to the drawings, wherein like reference numerals designate identical or corresponding elements. Throughout the following description, the term “proximal” should be understood as referring to the portion of the insertion device, or component thereof, that is closer to the clinician during proper use, and the term “distal” should be understood as referring to the portion of the insertion device, or component thereof, that is further from the clinician during proper use. Additionally, the terms “hemorrhoidal tissue,” and the like, should be understood as referring to hemorrhoidal tissue, as well as tissue positioned adjacent to hemorrhoidal tissue, including mucosal tissue. While the presently disclosed insertion device is particularly suited for surgical hemorrhoid procedures, the term “hemorrhoid procedure” should be understood to encompass surgical hemorrhoidectomies, hemorrhoidopexies, mucosectomies, procedures for the treatment of colon prolapse, and all such related procedures. The present disclosed insertion device can also be used for surgical procedures other than hemorrhoid procedures.
Referring to
The surgical fastener applying apparatus 10 includes a handle assembly 12, a central body portion 14 with an outer tube 16, and a distal head portion 18. The handle assembly 12 includes a stationary handle 20, a firing trigger 22, and a rotatable approximation knob 24.
The head portion 18 of the surgical fastener applying apparatus 10 includes an anvil assembly 26 and a shell assembly 28. The anvil assembly is repositionable between an un-approximated position, wherein the anvil assembly 26 is spaced a distance from the shell assembly 28 (as in
When the surgical fastener applying apparatus 10 is assembled, the anvil assembly 26 is positioned within an anvil retainer 30 that is movable relative to the shell assembly 28 via an operative connection to the approximation knob 24. Accordingly, during use of the surgical fastener applying apparatus 10, rotation of the approximation knob 24 effectuates movement of the anvil retainer 30, and consequently, the anvil assembly 26, in relation to the shell assembly 28 to thereby transition the anvil assembly 26 between the un-approximated and approximated positions.
The surgical fastener applying apparatus 10 further includes a firing mechanism to facilitate the ejection of a plurality of surgical fasteners 32 (
Referring back to
The anoscope 1200 includes a dished proximal flange 1202, and a sleeve 1204 with respective proximal and distal ends 1206, 1208 that are spaced apart along a longitudinal axis “Y.” The flange 1202 extends outwardly from the proximal end 1206 of the sleeve 1204 relative to the longitudinal axis “Y,” and includes respective first and second circumferentially spaced ends 1210, 1212. The ends 1210, 1212 of the flange 1202 are connected by an arcuate portion 1214, and define a gap “G”. The arcuate portion 1214 may define an arc of approximately 180°. However, the arc defined by the arcuate portion 1214 may be either larger or smaller in alternative embodiments of the present disclosure.
The anoscope 1200 further includes a single wing 1216 that extends outwardly from the flange 1202 relative to the longitudinal axis “Y” in a manner resulting in a configuration that is asymmetrical about a plane extending along the longitudinal axis “Y” that bisects the flange 1202. The wing 1216 is configured and dimensioned for manual engagement by the clinician to facilitate manipulation of the anoscope 1200 during the course of the surgical hemorrhoid procedure. In one embodiment of the anoscope 1200, the wing 1216 may be positioned adjacent one of the ends 1210, 1212 of the flange 1202, e.g., the second end 1212, as shown in
Referring to
Referring again to
The sleeve 1204 of the anoscope 1200 extends distally from the flange 1202 and defines an internal dimension that allows for removable reception of the obturator 1100 therein. The sleeve 1204 includes a closed distal tip 1220 having an atraumatic, e.g., conical configuration. This configuration facilitates the dilation of tissue, such as the patient's anal canal, and thus, insertion and advancement of the anoscope 1200, as well as rotation of the anoscope 1200 once positioned internally.
In one embodiment of the anoscope 1200a, which can be seen in
Returning to
The configuration of the bridge 1226 may be altered or varied in alterative embodiments of the anoscope 1200 to realize any suitable axial length. In one particular embodiment, the bridge 1226 defines an axial length of about 1.5 cm (approximately 0.59 inches), and is positioned such that respective proximal and distal ends 1232, 1234 of the bridge 1226 are located about 3 cm (approximately 1.18 inches) and about 4.5 cm (approximately 1.77 inches) from the proximal end 1206 of the sleeve 1204, i.e., from the point of contact between the flange 1202 and the sleeve 1204. In this embodiment, during the course of a hemorrhoid procedure, upon insertion of the anoscope 1200 into the patient's anal canal, the distal opening 1230 in the sleeve 1204 will be positioned above (proximally) of the dentate line, which is located in the human anal canal about 2 cm (approximately 0.78 inches) from the anus. With the distal opening 1230 positioned proximally of the dentate line, purse stringing, and subsequent tissue removal, will also occur proximally of the dentate line.
With reference now to
As best seen in
The use and operation of the insertion device 1000 (
As seen in
After purse stringing is completed, the anoscope 1200 is removed from the patient's anus. The anvil assembly 26 (
Following attachment of the suture “S” to the center rod 42, the anvil assembly 26 is re-connected to the surgical fastener applying apparatus 10 by positioning the anvil assembly 26 within the anvil retainer 30, as shown in
With reference now to
The structure of the first wing 1416A differs from that of the second wing 1416B such that the configuration of the anoscope 1400 is asymmetrical about a plane extending along the longitudinal axis “Y” that bisects the flange 1402. In the specific embodiment of the anoscope 1400 illustrated in
To facilitate manual engagement with the wings 1416A, 1416B, the wings 1416A, 1416B include a raised protrusion 1436. The protrusions 1436 extend away from the wings 1416A, 1416B in a proximal direction to define a height “H,” and corresponding adjacent area 1438 to thereby enhance maneuverability of the anoscope 1400.
In the illustrated embodiment, the protrusions 1436 are configured as ribs, or flanges, 1440 that are positioned adjacent a peripheral edge “P” of the wings 1416A, 1416B. It should be understood, however, that in alternative embodiments of the anoscope 1400, the protrusion 1436 may assume any configuration suitable for the intended purpose of increasing the clinician's control over, and ability to manipulate, the anoscope 1400, and that other configurations for the protrusion 1436 are not beyond the scope of the present disclosure. It is also envisioned that the wings 1416A, 1416B may be devoid of the protrusions 1436 such that the wings 1416A, 1416B include a substantially uniform proximal surface 1418, i.e., a surface that is free from any indentations, protrusions, or other such irregularities, as discussed above with respect to the anoscope 1200 (
To facilitate manual engagement with the wings 1516A, 1516B, as with the aforedescribed anoscope 1400 (
Although illustrated as a rib, or flange, 1540 that extends along the peripheral edge “P” of the wings 1516A, 15166, it should be understood that the protrusions 1536 may assume alternative configurations in additional embodiments of the anoscope 1500, and that the protrusions 1536 (as well as protrusions 1436 of
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
Claims
1-20. (canceled)
21. A method of surgery, the method comprising:
- inserting an anoscope into an anus of a patient with a bridge of the anoscope positioned past a dentate line, the anoscope including a flange and an elongate body having an outer wall, the flange including a wing and having first and second ends spaced apart from one another to define a gap, the wing being positioned about the flange such that the flange is asymmetrical about a vertical plane bisecting the flange, the outer wall defining a proximal opening and a distal opening longitudinally aligned with one another, the bridge separating the proximal opening and the distal opening;
- purse-stringing hemorrhoidal tissue positioned within the outer wall of the anoscope, the hemorrhoidal tissue passing through the distal opening of the anoscope; and
- withdrawing the anoscope from the anus of the patient.
22. The method according to claim 21, wherein purse-stringing the hemorrhoidal tissue includes rotating the anoscope.
23. The method according to claim 21, wherein purse-stringing the hemorrhoidal tissue includes attaching a suture to a first portion of the hemorrhoidal tissue positioned within the outer wall of the anoscope and rotating the anoscope to attach the suture to a second portion of the hemorrhoidal tissue.
24. The method according to claim 21, further comprising inserting a surgical stapler into the anus of a patient after withdrawing the anoscope.
25. The method according to claim 21, further comprising assembling an insertion device before inserting the anoscope into the anus of a patient.
26. The method according to claim 25, wherein assembling the insertion device includes positioning the anoscope within a port.
27. The method according to claim 26, wherein inserting the anoscope into the anus of the patient includes positioning the port in the anus.
28. The method according to claim 27, further comprising securing the port to the patient.
29. The method according to claim 25, wherein assembling the insertion device includes positioning an obturator within the outer wall of the anoscope.
30. The method according to claim 29, wherein inserting the anoscope into the anus of the patient includes observing the position of the bridge within the anus of the patient with the obturator during insertion of the anoscope and withdrawing the obturator from the anoscope after the bridge is positioned past the dentate line.
Type: Application
Filed: Oct 26, 2015
Publication Date: Feb 11, 2016
Inventors: Thomas Wenchell (Durham, CT), Christopher Switalski (Glastonbury, CT)
Application Number: 14/922,649