Method of making an intramedullary bone plug and bone plug made thereby
First Claim
1. A method of making an inflatable intramedullary bone canal plug for plugging an open-ended intramedullary canal of a bone which comprises the steps of:
- (I) forming a hollow expandable container of a biocompatible elastomeric material having (a) a first container wall side having a configuration which forms a hollow interior region within said plug for receiving a pressurizing amount of a biocompatible fluid and has an elongated member of elastomeric material affixed to said first wall side at one end of the container and (b) a second container wall side opposite and part of the same container wall as is the first wall side having a configuration which is adapted to be received within said canal, said container having an opening situated opposite said elongated member which extends completely through said first and second container wall sides, said opening being at least substantially as wide as the width of the elongated member and no larger than the width of the container at the region where the opening is located,(II) forming a channel extending completely through the center of said member and through said wall sides, said channel being sealingly engageable with a cooperating injection means,(III) placing a shrinkable elastomeric band of a biocompatible elastomeric material over said elongated member, said band having an inner configuration which is larger than the outer configuration of said member before shrinking and in its shrunken state is sufficiently smaller than the outside configuration of the elongated member so as to compress the elongated member and the channel running therethrough in a sealing fashion,(IV) shrinking the elastomeric band over the elongated member to form a resealable valve assembly for receiving said injection means, and(V) sealing said opening with an endcapping means,wherein said container wall has a sufficient strength and thickness to contain pressure from injection of said biocompatible fluid into the hollow interior region of said container and wherein said container further contains a means for the controlled release of injected fluid to reduce the pressure within said interior region of a pressurizing amount of said fluid.
1 Assignment
0 Petitions
Accused Products
Abstract
This invention relates to a method of making an inflatable bone plug for plugging the open end of an intramedullary bone canal which is capable of restricting the flow of bone cement, particularly, during the insertion of bone cement, particularly during the pressurized injection of such a cement, during an operative procedure involving the fixation of the stem of an artificial joint prosthesis such as a femoral hip joint prosthesis to the end of a bone such as a femur. The bone plug is designed to be pressurized with a biocompatible fluid and to thereafter deflate in a controlled manner after the cement hardens. Preferably, the bone plug is made by forming a hollow expandable container of a silicone elastomer permeable to carbon dioxide gas which has a valve stem attached to one end of the container and an opening at the opposite end of the container. A shrinkable elastomeric band is placed over the valve stem in which a channel has been made to receive a further cooperating injection means such as a needle. The elastomeric band shrinks over the valve stem to form a resealable valve assembly. The valve assembly is located in the hollow interior of the bone plug and the opening opposite the valve stem is sealed to complete construction of the bone plug. When such a plug is inflated with a biocompatible fluid such as carbon dioxide, the plug remains pressurized for a sufficient amount of time to allow the cement to harden, but the pressure drops to a minimum within about 24 hours after inflation.
284 Citations
22 Claims
-
1. A method of making an inflatable intramedullary bone canal plug for plugging an open-ended intramedullary canal of a bone which comprises the steps of:
-
(I) forming a hollow expandable container of a biocompatible elastomeric material having (a) a first container wall side having a configuration which forms a hollow interior region within said plug for receiving a pressurizing amount of a biocompatible fluid and has an elongated member of elastomeric material affixed to said first wall side at one end of the container and (b) a second container wall side opposite and part of the same container wall as is the first wall side having a configuration which is adapted to be received within said canal, said container having an opening situated opposite said elongated member which extends completely through said first and second container wall sides, said opening being at least substantially as wide as the width of the elongated member and no larger than the width of the container at the region where the opening is located, (II) forming a channel extending completely through the center of said member and through said wall sides, said channel being sealingly engageable with a cooperating injection means, (III) placing a shrinkable elastomeric band of a biocompatible elastomeric material over said elongated member, said band having an inner configuration which is larger than the outer configuration of said member before shrinking and in its shrunken state is sufficiently smaller than the outside configuration of the elongated member so as to compress the elongated member and the channel running therethrough in a sealing fashion, (IV) shrinking the elastomeric band over the elongated member to form a resealable valve assembly for receiving said injection means, and (V) sealing said opening with an endcapping means, wherein said container wall has a sufficient strength and thickness to contain pressure from injection of said biocompatible fluid into the hollow interior region of said container and wherein said container further contains a means for the controlled release of injected fluid to reduce the pressure within said interior region of a pressurizing amount of said fluid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 21)
-
-
11. An inflatable intramedullary bone canal plug for plugging an open-ended intramedullary canal of a bone comprising a plug produced by a method which comprises the steps of:
-
(I) forming a hollow expandable container of a biocompatible elastomeric material having (a) a first container wall side having a configuration which forms a hollow interior region within said plug for receiving a pressurizing amount of a biocompatible fluid and has an elongated member of elastomeric material affixed to said first wall side at one end of the container and (b) a second container wall side opposite and part of the same container wall as is the first wall side having a configuration which is adapted to be received within said canal, said container having an opening situated opposite said elongated member which extends completely through said first and second container wall sides, said opening being at least substantially as wide as the width of the elongated member and no larger than the width of the container at the region where the opening is located, (II) forming a channel extending completely through the center of said member and through said wall sides, said channel being sealingly engageable with a cooperating injection means, (III) placing a shrinkable elastomeric band of a biocompatible elastomeric material over said elongated member, said band having an inner configuration which is larger than the outer configuration of said member before shrinking and in its shrunken state is sufficiently smaller than the outside configuration of the elongated member so as to compress the elongated member and the channel running therethrough in a sealing fashion, (IV) shrinking the elastomeric band over the elongated member to form a resealable valve assembly for receiving said injection means, and (V) sealing said opening with an endcapping means, wherein said container wall has a sufficient strength and thickness to contain pressure from injection of said biocompatible fluid into the hollow interior region of said container and wherein said container further contains a means for the controlled release of injected fluid to reduce the pressure within said interior region of a pressurizing amount of said fluid. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 22)
-
Specification