Cement plug for the medullary canal of a bone and coacting tool for installing same

• US 5,092,891 A
• Filed: 03/08/1990
• Issued: 03/03/1992
• Est. Priority Date: 03/08/1990
• Status: Expired due to Fees

• Current Assignee: Frederick J. Kummer, Steven A. Stuchin
• Original Assignee: Frederick J. Kummer, Steven A. Stuchin
• Inventors: Stuchin, Steven A., Kummer, Frederick J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Brittingham, Debra S.
• Application Number:
  US07/490,711
• Time in Patent Office: 726 Days
• Field of Search: 623/16, 623/16 A, 623/23, 606/62, 606/63
• US Class Current: 623/23.48
• CPC Class Codes: A61F 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/4614 of plugs for sealing a cement-receiving space
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0017 Angular shapes

Abstract

A cement plug for sealing the medullary canal of a bone to restrict the flow of cement, debris, etc. beyond a predetermined point in the canal. The cement plug, which is executed in a biocompatible plastic, comprises (1) a tubular body that is a slit axially at three or more locations to define resilient fingers, (2) an obturator plate located at the upper end of the body, (3) a tapered conical plug that can be advanced through the lower end of the body and intot he interior thereof, and (4) a threaded bolt that extends through the tubular body and into the conical plug. Locator holes are formed in the obtrator plate, and sharpe edges, teeth, or locator tab(s) are formed on the outer surface of the conical plug so that said plug does not rotate relative to the tubular body of the plug. An insertion tool, including an inner tube and an outer tube, is engaged within the locator by depending plins. The lower end of the inner tube engages the upper end of the threaded bolt. By rotating a handle so that the tubes move relative to one another, a torquing force is imparted to the head of the bolt. The bolt draws the plug upwardly into the interior of the plug body. Such upward movement of the tapered conical plug forces the resilient fingers outwardly into secure engagement with the wall defining the medullary canal.

Cement, under pressure, is then forced down the medullary canal. The obturator plate, which is situated perpendicular to the body of the plug at the upper end thereof, serves as a barrier to the flow of cement. The obturator plate extends transversely across the medullary canal and may even bow slightly under such pressure; however, the plug will not slip and the cement will now flow, leak or migrate past the plate and adversely impact upon the resilient fingers. The obturator plate may even serve as a secondary gripping member. The plug thus forms a stable platform atop which a prosthesis may be accurately positioned.

Claims

1. A cement plug adapted to be used in a medullary canal, said plug comprising:

a) a tubular body executed in a biocompatible plastic,

b) said body having an upper end and a lower end,

c) said body being slit axially in several parallel areas extending upwardly from its lower end to define a plurality of resilient fingers,

d) an obturator plate located at the upper end of said body and extending perpendicular thereto,

e) said plate having a centrally located aperture,

f) a tapered conical plug that fits into the lower end of said tubular body,

g) said tapered conical plug having a threaded axial bore extending therethrough;

h) a bolt having an enlarged head and an elongated shank, said shank having threads along its exterior surface,

i) the head of said bolt resting upon said obturator plate with the shank extending axially through said tubular body and into the threaded bore of said tapered conical plug,

j) whereby the application of a rotational force to the head of said bolt in a first direction draws said tapered conical plug upwardly into said tubular body and forces said resilient flexible fingers outwardly to engage the wall of a surrounding medullary canal at several spaced points.

2. A cement plug as defined in claim 1 wherein said tubular body is executed in non-porous plastic.

3. A cement plug as defined in claim 1 wherein said tubular body is slit at three, equally spaced, areas.

4. A cement plug as defined in claim 1 wherein each slit extends upwardly for more than half the axial length of the tubular body.

5. A cement plug as defined in claim 1 wherein said obturator plate is annular in shape when viewed from above.

6. A cement plug as defined in claim 5 wherein the diameter of said obturator plate is significantly greater than the diameter of said tubular body, the diameter of said obturator plate being selected to match the size of the medullary canal.

7. A cement plug as defined in claim 1 wherein serrations are formed on the exterior of said tapered conical plug to facilitate spreading the resilient fingers on said tubular body.

8. A cement plug as defined in claim 1 wherein the exterior surface of said tapered conical plug is divided into several distinct faces, the adjacent faces meeting at a sharp corner, and the number of corners being equal to the number of axial slits in said tubular body.

9. A cement plug as defined in claim 1 wherein a tab is formed on the outer surface of said tubular body of said plug, said tab cooperating said axial slits in said tubular body to prevent rotation of said tapered conical plug as said tapered conical plug enters said tubular body.

10. In combination, a cement plug adapted to be used in a medullary canal, and a manually operable tool for positioning and locking said cement plug in a fixed location within the medullary canal,said plug comprising:

a) a tubular body executed in a bio-compatible plastic,

b) said body having an upper end and a lower end,

c) said body being slit axially in several parallel areas extending upwardly from its lower end to define a plurality of resilient fingers,

d) an obdurator plate located at the upper end of said body and extending perpendicular thereto,

e) said plate having a centrally located aperture,

f) a tapered conical plug that fits into the lower end of said tubular body,

g) said tapered conical plug having a threaded axial bore extending therethrough,

h) a bolt having an enlarged head and an elongated shank, said shank having threads along its exterior surface,

i) the head of said bolt resting upon said obdurator plate with the shank extending axially through said tubular body and into the threaded bore of said tapered conical plug,

j) a plurality of locator holes formed in said obdurator plate,

2) said insertion tool comprising;

a) an inner tubular member,

b) an outer tubular member, said tubular members mounted concentrically to enable relative movement therebetween,

c) a plurality of aligning pins projecting from the lower end of said outer tube for insertion into said locator holes in said obdurator plate,

d) means defined in the lower surface of said inner tubular member to receive the head of said bolt therein, and

e) manually operable means at the upper end of said inner tubular member for rotating same to deliver a torquing force to the head of said bolt to thereby draw said tapered conical plug into said tubular body and force the resilient fingers outwardly into secure engagement within the medullary canal, with the obturator plate serving as a barrier across the medullary canal above said fingers.

11. A cement plug and a manually operable tool as defined in claim 10 wherein the head of said bolt is polygonal in shape, and said inner tube of said tool has a lower, transversely extending surface with a polygonal recess to fit over the head of said bolt.

12. A cement plug and a manually operable tool as defined in claim 10 wherein the head of said bolt has a slot formed therein, and said inner tube of said tool has a depending screwdriver blade that fits into said slot on said bolt.

13. A cement plug and a manually operable tool as defined in claim 10 wherein said locator holes in said obdurator plate extend only partially through said plate, said aligning pins in said tool being equal in number to said locator holes.

14. A cement plug and a manually operable tool as defined in claim 10 wherein a pair of locator holes in said obdurator plate are spaced diametrically apart from each other.

15. A cement plug and a manually operable tool as defined in claim 10 wherein a depth gauge is located on the exterior of said outer tube of said tool to indicate the depth of insertion of the tool into the medullary canal.

16. A cement plug adapted to be used in a medullary canal, said plug comprising:

a) a tubular body (22) executed in a biocompatible plastic,

b) said body having an upper end and a lower end,

c) said body being slit axially upwardly from its lower end, at several spaced areas, to define a plurality of resilient fingers (28),

d) a tapered conical plug (24) that fits into the lower end of said tubular body,

e) said tapered conical plug having a threaded bore extending axially therethrough,

f) a bolt (38) having an enlarged head (40) and an elongated shank (42), said shank having threads (44) defined along its exterior surface,

g) the application of a rotational force to the head of said bolt in a first direction drawing said conical plug upwardly into said tubular body and forcing said resilient fingers outwardly to engage the wall of the surrounding medullary canal at several spaced points (see FIG.

     5); and

h) the invention being characterized by an obturator plate (30) located at the upper end of said tubular body and perpendicular thereto, said plate being greater in transverse dimensions than said body and extending across the medullary canal to serve as a barrier for preventing debris in the medullary canal from passing therebeyond (see FIG.

     6).

17. A cement plug as defined in claim 16 wherein said obdurator plate is substantially annular in shape when viewed from above (see FIG. 2) and contacts the medullary canal around its perimeter, the obdurator plate being selected to be sufficiently rigid to engage the bone defining the medullary canal, thereby functioning as a secondary locking member for said plug and augmenting the engagement forces of said resilient fingers (see FIG. 6).

18. A cement plug as defined in claim 17 wherein said obdurator plate may be sufficiently flexible to bow under the weight of the debris and bone cement in the medullary canal while still maintaining continuous contact with the bone defining the medullary canal.

19. A cement plug as defined in claim 18 wherein said obdurator plate has a central aperture to allow the shank of said bolt to pass therethrough, the head of said bolt resting on said obdurator plate when said cement plug is installed in the medullary canal (see FIG. 5).