Fecal impaction removal tool
RE046306 ยท 2017-02-14
Assignee
Inventors
Cpc classification
A61B17/22
HUMAN NECESSITIES
A61M29/00
HUMAN NECESSITIES
International classification
A61B17/22
HUMAN NECESSITIES
Abstract
A manually manipulatable tool for removing a fecal impaction, the tool is adapted for insertion into a patient's rectum to engage and penetrate the impaction. The tool is fitted with flexible, arcuately configured elements collapsible at least partially during insertion into the rectum and penetration of the fecal impaction, withdrawal of the tool deploying the elements to exert traction on the impaction thus facilitating withdrawal of at least portions of the impaction. A body member of the tool is preferably elongated and can optionally be provided with a longitudinally extending lumen for introduction of an enema solution concurrently with or independently of impaction removal.
Claims
1. An article of manufacture adapted for use in removal of a fecal impaction from a human being in need thereof and insertable into the rectum of said human being in need to manipulate the impaction, comprising: a body member, at least a portion of which extends outwardly of the rectum of the human being experiencing an impaction on insertion of a distal portion of the body member into the rectum by a user, an outwardly extending anterior portion of the body member graspable by the user of the article to engage the impaction and to insert the distal portion of the article into the impaction; at least one dilation body carried by the body member distally of said body member to facilitate entry of the body member into the rectum of the human being in need of removal of the impaction; .[.and,.]. at least one grappling element carried by the body member on the distal portion of the body member and anteriorly of the at least one dilation body, the at least one grappling element for gripping at least portions of the impaction, at least one end of the at least one grappling element extending outwardly of the body member a distance greater than a volumetric space defined by passage of the at least one dilation body on insertion of the distal portion of the body member into the rectum, the volumetric space being defined by the at least one dilation body in an uncompressed condition prior to insertion into the rectum of a human being in need of removal of the impaction, the at least one grappling element being compressible toward the body member to a position essentially within the volumetric space, the grappling element being abducted from the body member within the rectum to grip at least portions of the impaction on sufficient insertion of the at least one grappling element into the rectum of the human being in need and to remove at least portions of the impaction on withdrawal of the body member from the rectum of the human in need of impaction removal.Iadd.; and a second dilation body carried by the body member and proximally disposed with respect to the at least one grappling element, the second dilation body having a tapered configuration tapering to a narrower proximal section;.Iaddend. wherein the at least one grappling element is arcuately formed in a relaxed and uncompressed condition and comprises an inner body portion joined to the body member and ends extending outwardly away from the body member, the ends of the at least one grappling element being more proximally disposed relative to body member than the inner body portion.
2. The article of manufacture of claim 1 and further comprising a handle disposed anteriorly of the body member, the handle being grasped by the user and the distal portion of the body member being manually inserted into the rectum of the human being in need of impaction removal, the at least one dilation body and the at least one grappling element being carried by the body member into the rectum with the at least one grappling element being inserted into the impaction and gripping at least portions of the impaction.
3. The article of claim 1 wherein the body member comprises an elongated shaft formed of a relatively rigid material and wherein the at least one grappling element is formed of a relatively less rigid material and is disposed at the end of the shaft insertable into the rectum of the human being in need of removal of the impaction.
4. The article of claim 3 wherein the shaft has a lumen extending from a proximal end thereof and toward a distal end of the shaft, the proximal end being adapted to receive into a proximal opening of the lumen a fluid capable of acting on the impaction.
5. The article of claim 4 wherein at least one port is formed in the shaft in proximity to the at least one grappling element, the port communicating with the lumen so that the fluid within the lumen can pass from the shaft into contact with the impaction.
6. The article of claim 4 and further comprising means carried at the proximal end of the shaft for connection to a source of the fluid.
7. The article of claim 2 wherein the handle comprises loops oppositely disposed across the body member near an anterior portion of the body member, each loop being adapted to receive at least one finger of the user and being formed integrally with the body member, the loops facilitating grasping of the article as well as movement and manipulation of the article.
8. The article of claim 3 wherein the at least one dilation body is disposed at the distal end of the shaft.
9. The article of claim 8 wherein the at least one dilation body is formed integrally with the shaft.
10. The article of claim 8 wherein the at least one dilation body is conformed into an ogive shape with a distal tip rounded to facilitate insertion of the at least one dilation body into the rectum of a human being in need of removal of the impaction.
11. The article of claim 10 wherein the at least one dilation body is comprised of tapered elements disposed in a cruciform conformation and tapering distally.
.[.12. The article of claim 8 and further comprising a second dilation body carried by the shaft in spaced relation to the distal end of the shaft, the second dilation body tapering proximally of the shaft to facilitate withdrawal of the article from the rectum of a human being in need of removal of the impaction..].
13. The article of claim .[.12.]. .Iadd.1 .Iaddend.wherein the second dilation body is formed integrally with the shaft.
14. The article of claim .[.12.]. .Iadd.1 .Iaddend.wherein the at least one grappling element is disposed on the shaft between the at least one dilation body disposed at the distal end of the shaft and the second dilation body.
15. The article of claim 8 wherein the at least one grappling element is carried by the shaft proximally of and substantially in proximity to the at least one dilation body disposed at the distal end of the shaft.
16. The article of claim 1 wherein the at least one grappling element is formed of a material having a lesser durometer relative to the durometer of the material forming the body member.
17. The article of claim 1 and further comprising at least one ridge element formed on a proximal face of the at least one grappling element, the at least one ridge acting to further engage the impaction.
18. The article of claim 1 and further comprising means for reinforcing the at least one grappling element.
19. The article of claim 1 wherein .Iadd.the at least one grappling element comprises a plurality of grappling elements and .Iaddend.more than one of the grappling elements are carried by the body member in spaced relation to each other.
20. The article of claim 19 wherein longitudinal axes of body portions of adjacent grappling elements are aligned relative to each other.
21. The article of claim 19 wherein longitudinal axes of body portions of adjacent grappling elements are angularly disposed relative to each other.
22. The article of claim 21 wherein longitudinal axes of body portions of adjacent grappling elements are disposed at 90 angles to each other.
23. The article of claim 19 wherein at least three of the grappling elements are carried by the body member.
.Iadd.24. An article of manufacture adapted for use in removal of a fecal impaction from a human being in need thereof and insertable into the rectum of said human being in need to manipulate the impaction, comprising: a body member, at least a portion of which extends outwardly of the rectum of the human being experiencing an impaction on insertion of a distal portion of the body member into the rectum by a user; a distally disposed tip portion of said body member to facilitate entry of the body member into the rectum of the human being; at least one grappling element carried by the body member on the distal portion of the body member, a lumen disposed within the body member and extending to the at least one grappling element and capable of delivering fluid to the at least one grappling element; at least one dilation body carried by the body member and proximally disposed with respect to the at least one grappling element, the dilation body having a tapered configuration tapering to a narrower proximal section; each grappling element being compressible toward the body member and abducted from the body member within the rectum to grip at least portions of the impaction on sufficient insertion of the at least one grappling element into the rectum of the human being, and to remove at least portions of the impaction on withdrawal of the body member from the rectum of the human in need of impaction removal; each grappling element extending outwardly of the body member a distance greater than a volumetric space defined by the at least one dilation body in an uncompressed condition; wherein each grappling element is arcuately formed in a relaxed and uncompressed condition and comprises an inner body portion joined to the body member and an outer portion including a pair of opposed ends extending outwardly away from the body member, the ends of the at least one grappling element being more proximally disposed relative to the body member than the inner body portion..Iaddend.
.Iadd.25. The article of manufacture of claim 24, wherein the at least one grappling element comprises a plurality of grappling elements aligned along a longitudinal axis, the opposed ends of the grappling element each extend in a direction transverse to the body member and the plurality of grappling elements are aligned such that the opposed ends of adjacent grappling elements are rotated with respect to one another..Iaddend.
.Iadd.26. The article of claim 24 wherein each grappling element is compressible to a first insertion position adjacent to the body member..Iaddend.
.Iadd.27. The article of claim 26 wherein each grappling element has an unbiased position between the first insertion position and a second engaging position in the uncompressed condition, and wherein the grappling element moves from the unbiased position to the first insertion position upon insertion of the article..Iaddend.
.Iadd.28. The article of claim 27 wherein the unbiased position is a position with the outer portion extending toward the proximal portion of the body member..Iaddend.
.Iadd.29. The article of claim 24 wherein the at least one grappling element is formed of a resiliently flexible material..Iaddend.
.Iadd.30. The article of claim 24 wherein the at least one grappling element includes a proximal surface and a distal surface, the proximal surface configured to increase retention of at least portions of the impaction with the article during removal..Iaddend.
.Iadd.31. The article of claim 30 wherein the proximal surface includes a structural element configured to increase retention of at least portions of the impaction with the article during removal..Iaddend.
.Iadd.32. The article of claim 31 wherein the structural element is a ridge configured to increase retention of at least portions of the impaction with the article during removal..Iaddend.
.Iadd.33. The article of claim 29 wherein the at least one grappling element includes a surface and a reinforcement element on the surface extending radially outward from the body member configured to restrict flexure of the at least one grappling element..Iaddend.
.Iadd.34. The article of claim 24 wherein the tip portion includes a further dilation body to facilitate entry of the body member into the rectum of the human being, the further dilation body extending radially outward from the body member..Iaddend.
.Iadd.35. The article of claim 34 wherein the further dilation body is formed integrally with the body member..Iaddend.
.Iadd.36. The article of claim 34 wherein the further dilation body is comprised of elements disposed in a cruciform conformation..Iaddend.
.Iadd.37. The article of claim 34 wherein the further dilation body includes a base, and tapers distally from the base to facilitate the insertion of the distal end into the rectum of a human being and to minimally distend the impaction for minimal patient discomfort during insertion..Iaddend.
.Iadd.38. The article of claim 24, wherein the at least one dilation body includes a shoulder and tapers proximally from the shoulder to facilitate the automatic withdrawal of the distal end from the rectum of a human being..Iaddend.
.Iadd.39. The article of claim 34 wherein an engaging position of the grappling elements in the uncompressed condition includes the opposed ends extending radially beyond a radial extent of the further dilation body to engage at least a portion of the impaction..Iaddend.
.Iadd.40. The article of claim 24 wherein the lumen extends from the proximal portion toward the distal portion and includes one or more ports formed in the distal portion configured to allow fluid to pass from the lumen to contact at least portions of the impaction, the proximal portion including an opening adapted to receive a fluid capable of acting on the impaction, at least one port having a radial opening..Iaddend.
.Iadd.41. The article of claim 40, wherein the at least one port is disposed adjacent a grappling element of the at least one grappling element, configured to protect said port from occlusion during insertion of the article..Iaddend.
.Iadd.42. The article of claim 24 wherein the proximal portion comprises a handle graspable by a user..Iaddend.
.Iadd.43. The article of claim 24 wherein the at least one grappling element comprises a plurality of grappling elements aligned along a longitudinal axis including a first grappling element and a second grappling element longitudinally displaced from the first grappling element, the second grappling element rotated angularly around the longitudinal axis relative to the first grappling element..Iaddend.
.Iadd.44. The article of claim 26 wherein the at least one grappling element comprises a plurality of grappling elements formed of a resiliently flexible material and aligned along a longitudinal axis, each grappling element having an unbiased position between the first insertion position and a second engaging position, wherein the unbiased position is a position with the outer portion extending toward the proximal portion of the body member, and each grappling element moves from the unbiased position to the first insertion position upon insertion of the article, wherein the plurality of grappling elements include a first grappling element and a second grappling element longitudinally displaced from the first grappling element, the second grappling element rotated angularly around the longitudinal axis relative to the first grappling element..Iaddend.
.Iadd.45. The article of claim 44 wherein each grappling element includes a proximal surface having a structural element configured to increase retention of at least portions of the impaction with the article during removal..Iaddend.
.Iadd.46. The article of claim 45 wherein the lumen extends from the proximal portion toward the distal portion and includes a plurality of ports formed in the distal portion configured to allow fluid to pass from the lumen to contact at least portions of the impaction, the proximal portion including an opening adapted to receive a fluid capable of acting on the impaction, each port having a radial opening..Iaddend.
.Iadd.47. A method for engaging a fecal impaction in a human being with an article of manufacture adapted for use in removal of a fecal impaction from a human being in need thereof, comprising the steps of: providing a fecal impaction removal article including a body member, at least a portion of which extends outwardly of the rectum of the human being experiencing an impaction on insertion of a distal portion of the body member into the rectum by a user; a distally disposed tip portion of the body member to facilitate entry of the body member into the rectum of the human being; at least one grappling element carried by the body member on the distal portion of the body member, a lumen disposed within the body member and extending to the at least one grappling element and including ports capable of delivering fluid to the at least one grappling element; at least one dilation body carried by the body member and proximally disposed with respect to the at least one grappling element, the dilation body having a tapered configuration tapering to a narrower proximal section; each grappling element being compressible toward the body member, each grappling element extending outwardly of the body member a distance greater than a volumetric space defined by the at least one dilation body in an uncompressed condition; each grappling element being abducted from the body member within the rectum to grip at least portions of the impaction on sufficient insertion of the at least one grappling element into the rectum of the human being, and to remove at least portions of the impaction on withdrawal of the body member from the rectum of the human in need of impaction removal, wherein each grappling element is arcuately formed in a relaxed and uncompressed condition and comprises an inner body portion joined to the body member and a pair of opposed ends extending outwardly away from the body member, the ends of the at least one grappling element being more proximally disposed relative to the body member than the inner body portion; inserting the distal portion into the rectum of the human being with a fecal impaction until at least one of the ports is disposed in a portion of the impaction; delivering fluid through the lumen and through at least one of the ports having a radial opening to direct fluid to contact at least an internal portion of the impaction with the fluid and to loosen the impaction; and removing the distal portion from the rectum of the human being while causing the at least one grappling element to engage and remove portions of the loosened impaction..Iaddend.
.Iadd.48. The method of claim 47 wherein the delivering fluid includes delivering fluid to a plurality of the ports to direct fluid radially from the shaft to contact a plurality of portions of the impaction concurrently with the fluid..Iaddend.
.Iadd.49. The method of claim 47 wherein the at least one grappling element comprises a plurality of grappling elements disposed at different locations along a longitudinal axis and further comprising causing the grappling elements to cover and protect the ports during insertion and causing the grappling elements to extend away from the ports before delivering fluid..Iaddend.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF THE PREFERRED EMBODIMENTS
(21) Referring now to the drawings and particularly to
(22) The shaft 12 is terminated proximally by a handle 14 formed of loops 16 each capable of receiving one of a practitioner's fingers for ease of use of the tool 10 such as by application of torque to the tool 10 and especially for withdrawal of the tool 10 from the patient. The loops 16 are preferably formed integrally with the shaft 12 with each loop 16 being disposed in opposed relation in proximity to the proximal end of the shaft 12. The handle 14 is dimensioned to prevent entry of the entire tool 10 into the anus to prevent loss of the tool 10 into the rectum. As seen particularly in
(23) As is best seen in
(24) The shaft 12 terminates distally in a first dilator 28 of a substantially ogive conformation with a rounded tip 30, the dilator 28 preferably being formed integrally with the shaft 12. The dilator 28 is formed distally in a cruciform configuration from a plurality of regularly spaced elements 32 that taper toward the tip 30 and join proximally to a substantially circular base 34 joined to the shaft 12. The elements 32 as well as surfaces of the base 34 are relieved, that is, essentially rounded such that the dilator 28 can be inserted into and withdrawn from a patient's anus with case and with minimal discomfort to the patient. The dilator 28 can be lubricated prior to insertion even though the material from which the dilator 28 as well as the shaft 12 inter alia is formed is chosen to exhibit low surface friction. The dilator 28 is shaped and sized such that insertion minimally distends an impacted fecal mass as well as the rectal vault to minimize patient discomfort.
(25) A proximal dilator 36 is formed integrally with the shaft 12 in spaced relation to the distally disposed dilator 28. The dilator 36 is conically shaped proximally to facilitate removal of the tool 10 once manipulation of an impacted fecal mass has occurred. The dilator 36 can be formed with smooth, low friction surfaces over the exterior thereof and can be formed in a cruciform configuration as is the dilator 28 is formed distally except with such cruciform shape extending in the direction of withdrawal of the tool 10. The dilator 36 is intended to be received through the anus of a patient during insertion of the tool 10 and is therefore configured with an inwardly rounded annular shoulder 38 formed distally of the dilator 36. The dilator 36 configured as aforesaid facilitates the atraumatic withdrawal of the tool 10 through dilation of the anus and relaxation of the anal sphincter. Such relaxation and dilation permit withdrawal of at least portions of an impacted fecal mass engaged with the tool 10 with minimal effort and with minimal discomfort to the patient.
(26) The shaft 12 of the tool 10 is further seen to be configured with spaced sets 24 of the flexible, arcuately configured grappling elements 26 disposed between the distally disposed dilator 28 and the proximal dilator 36. As is seen in
(27) Each of the grappling elements 26 comprising each one of the sets 24 can be identical and can comprise a substantially straight-edged inner body portion 27 having arcuate perimetric portions 29 at each end of said body portion 27. The elements 26 are preferably formed on and about the shaft 12 by co-extrusion of a plastic or resinous material of lesser durometer than forms the shaft 12 during formation of the tool 10. The material forming the elements 26 are thus preferably formed of a softer material to allow flexure of a sufficient degree to permit each element 26 of each arcuately-shaped set 24 to bend inwardly toward the shaft 12 on insertion of the tool 10 into the anus of a patient. The elements 26 can bend sufficiently to compress inwardly to positions wherein the perimetric portion 29 of each said element 26 virtually lies per se along the shaft 12 such that said element 26 need not create an entry path into the anus or into an impacted fecal mass. However, on full receipt into the fecal mass, compressing pressure on the elements 26 is either released due to restoring spring-like forces provided by the elements 26 per se and/or by manipulation of the tool 10 in one or more series of short inward and outward movements of the tool 10. The elements 26 during engagement with a fecal mass thus extend outwardly of the shaft 12 to positions similar to those existing prior to insertion. The fecal mass is thus engaged by the elements 26 in a hooking action and can be fragmented while embedded within the mass. Ridges 31 formed on rearwardly facing surfaces of the elements 26 act to increase retention of at least portions of the fecal mass on the tool 10.
(28) As is best seen in
(29) Each set 24 of the elements 26 are seen to be oriented in an aligned relation to adjacent sets 24 as seen in
(30) Once the tool 10 has been inserted into the anus of a patient and manipulated to abduct the elements 26 from a position folded toward and along the body of the shaft 12 as is caused by insertion, the impacted fecal mass is engaged and then manipulated through manual movement of the handle 14 by a practitioner, these movements being translated along the shaft 12 to the opposite end of the tool 10 carrying the dilators 28 and 36 as well as the sets 24 of grappling elements 26. The length of the shaft 12 is chosen to be sufficient to efficiently permit insertion of the dilators 28 and 36 as well as the elements 26 and to effectively transmit forces exerted on the handle 14 to the distal end of the tool 10. It is to be understood that the grappling elements 26 can be formed in alternate embodiments of a sufficiently rigid material, such as the material forming the shaft 12, so that the sets 24 do not appreciably deform toward the shaft 12.
(31) The pairs of the oppositely aligned ports 22 can best be seen in
(32) Referring now to
(33) As is seen in
(34) Referring now to
(35) While the invention has been described herein in relation to particular embodiments thereof, it is to be understood that the invention can be configured other than as explicitly disclosed and described herein. In practice, the elements 26 can be configured other than as described herein, varying configurations of the elements 26 contemplated by the invention being intended to connect to, grasp, clasp, dig into and/or engage with an impacted fecal mass as disclosed herein and being capable of formation other than as detailed herein. The articles of the invention can further be formed of differing materials consistent with the function of the articles or portions thereof without departing from the scope of the invention. Accordingly, the scope of the invention is to be interpreted in light of the appended claims.