Fecal impaction removal tool

• US RE46,306 E1
• Filed: 01/30/2014
• Issued: 02/14/2017
• Est. Priority Date: 08/11/2008
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Centurion Medical Products Corporation
• Inventors: Bentley, Burton II
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US14/168,464
• Time in Patent Office: 1,111 Days
• Field of Search: 604/39, 604104-106, 604275-279, 604/514, 604/911, 604/73, 604/317, 604/48, 606/127, 606/128, 606/197, 606/198, 606/122, 606/124, 606/207
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22037 Fecal impaction removal
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 3/02 Enemata; Irrigators

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; 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;

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 1 wherein the second dilation body is formed integrally with the shaft.

14. The article of claim 12 1 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 the at least one grappling element comprises a plurality of grappling elements and 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.

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.

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.

26. The article of claim 24 wherein each grappling element is compressible to a first insertion position adjacent to the body member.

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.

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.

29. The article of claim 24 wherein the at least one grappling element is formed of a resiliently flexible material.

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.

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.

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.

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.

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.

35. The article of claim 34 wherein the further dilation body is formed integrally with the body member.

36. The article of claim 34 wherein the further dilation body is comprised of elements disposed in a cruciform conformation.

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.

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.

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.

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.

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.

42. The article of claim 24 wherein the proximal portion comprises a handle graspable by a user.

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.

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.

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.

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.

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.

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.

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.