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US5333626A Expired / Lapsed US ⏱️ 0.0 years remaining

Preparation of bone for transplantation

Assignee: Warsaw Orthopedic Inc
•
Filing: 1991-12-31
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Granted: 1994-08-02
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Expires: 2011-12-31
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Abstract

Abstract The invention provides a simple, safe and effective method for treating bone and making it suitable for transplantation comprising: (a) contacting said bone with a global decontaminating agent effective to inactivate bacteria, fungi, virus and parasites; (b) cleaning said bone; and (c) terminally decontaminating said cleaned bone by contacting it with a global decontaminating agent effective to inactivate bacteria, fungi, virus and parasites. The invention also provides a method of cleaning bone which can be used in step (b) of the method described above and comprises contacting the bone with detergent under high pressure washing conditions at elevated temperatures.

Inventors

  • 👤 Brenda S. Morse
  • 👤 Edward Shanbrom

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-04 23:55
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2/30; A61F2/46; A61F2/4644; A61K; A61K35/00; A61K35/12; A61K35/32; A61L2/00; A61L2/16; A61L2/18; A61L27/3604; A61L27/3608; A61L27/3641; A61L27/3645; A61L27/365; A61F2002/2825; A61F2002/2828; A61F2002/2835; A61F2002/2839; A61F2002/4646; A61L2103/00; A61L2103/05; A61L2430/00; A61L2430/02; Y; Y10; Y10S; Y10S623/00; Y10S623/92; Y10S623/923

Claims Analysis

Total Claims: 54
Claim 1
Independent Claim 38 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent.
Claim 2
Independent Claim 38 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent.
Claim 3
Dependent Claim 20 words
A method according to claim 1 wherein said high pressure washing condition comprises lavage with a high pressure liquid stream.
Claim 4
Dependent Claim 19 words
The method of claim 2 wherein said high pressure liquid jet stream is at about 100 to 300 psi.
Claim 5
Dependent Claim 19 words
The method of claim 2 wherein said high pressure liquid jet stream is at about 500 to 1,500 psi.
Claim 6
Dependent Claim 11 words
The method of claim 2 wherein said liquid is a detergent.
Claim 7
Dependent Claim 15 words
A method according to claim 1 wherein said high pressure washing condition comprises vigorous agitation.
Claim 8
Dependent Claim 23 words
A method according to claim 1 wherein said high pressure washing thereof is conducted at a temperature between about 37 and 80° C.
Claim 9
Dependent Claim 15 words
Bone suitable for transplantation into a human produced according to the method of claim 1.
Claim 10
Dependent Claim 28 words
The method of claim 1 wherein said bone is further terminally decontaminated by contacting it with a global decontaminating agent effective to inactivate bacteria, fungi, virus and parasites.
Claim 11
Dependent Claim 13 words
The method of claim 1 wherein said cleaning is conducted at elevated temperatures.
Claim 12
Dependent Claim 16 words
The method of claim 10 wherein said elevated temperatures range from about 37° to 80° C.
Claim 13
Dependent Claim 16 words
The method of claim 10 wherein said elevated temperatures range from about 37° to 60° C.
Claim 14
Dependent Claim 12 words
The method of claim 1 wherein said detergent is a non-ionic detergent.
Claim 15
Dependent Claim 11 words
The method of claim 13 wherein said non-ionic detergent is octylphenoxypolyethoxyethanol.
Claim 16
Dependent Claim 14 words
The method of claim 13 wherein said non-ionic detergent is polyoxyethylene (20) sorbitan monooleate.
Claim 17
Dependent Claim 14 words
The method of claim 1 wherein the bone is additionally contacted with hydrogen peroxide.
Claim 18
Independent Claim 108 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said method comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to a high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites, said method further comprising an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent also having said aforementioned capability.
Claim 19
Independent Claim 108 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said method comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to a high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites, said method further comprising an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent also having said aforementioned capability.
Claim 20
Dependent Claim 15 words
Bone suitable for transplantation into a human produced according to the method of claim 17.
Claim 21
Dependent Claim 25 words
The method of claim 17 wherein said high pressure washing conditions include vigorous agitation, sufficient to drive said detergent into internal matrices of the bone.
Claim 22
Dependent Claim 22 words
The method of claim 17 wherein said high pressure washing conditions include contacting said bone with a high pressure liquid jet stream.
Claim 23
Dependent Claim 19 words
The method of claim 20 wherein said high pressure liquid jet stream is at about 100 to 3000 psi.
Claim 24
Dependent Claim 19 words
The method of claim 20 wherein said high pressure liquid jet stream is at about 500 to 1,500 psi.
Claim 25
Dependent Claim 11 words
The method of claim 20 wherein said liquid is a detergent.
Claim 26
Dependent Claim 13 words
The method of claim 17 wherein said cleaning is conducted at elevated temperatures.
Claim 27
Dependent Claim 16 words
The method of claim 24 wherein said elevated temperatures range from about 37° to 80° C.
Claim 28
Dependent Claim 16 words
The method of claim 24 wherein said elevated temperatures range from about 37° to 60° C.
Claim 29
Dependent Claim 12 words
The method of claim 17 wherein said detergent is a non-ionic detergent.
Claim 30
Dependent Claim 11 words
The method of claim 27 wherein said non-ionic detergent is octylphenoxypolyethoxyethanol.
Claim 31
Dependent Claim 14 words
The method of claim 17 wherein the bone is additionally contacted with hydrogen peroxide.
Claim 32
Independent Claim 80 words
A method of preparing bone for transplantation into a human, said bone containing an internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom, comprising contacting said internal matrix with a solution, itself comprising a decontaminating agent or a detergent, and maintaining said solution under high pressure in contact with said matrix for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 33
Independent Claim 80 words
A method of preparing bone for transplantation into a human, said bone containing an internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom, comprising contacting said internal matrix with a solution, itself comprising a decontaminating agent or a detergent, and maintaining said solution under high pressure in contact with said matrix for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 34
Independent Claim 79 words
A method of preparing bone for transplantation into a human, said bone containing internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom at a predetermined pressure, said method comprising the step of subjecting said matrix to pressure different from said predetermined value, and then maintaining said matrix in contact therewith for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 35
Independent Claim 79 words
A method of preparing bone for transplantation into a human, said bone containing internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom at a predetermined pressure, said method comprising the step of subjecting said matrix to pressure different from said predetermined value, and then maintaining said matrix in contact therewith for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 36
Independent Claim 89 words
A method of preparing bone for transplantation into a human, said bone containing internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom at a predetermined pressure, said method comprising the steps of contacting said matrix with a solution comprising a decontaminating agent or a detergent at pressure different from said predetermined value, and then maintaining said matrix in contact therewith for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 37
Independent Claim 89 words
A method of preparing bone for transplantation into a human, said bone containing internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom at a predetermined pressure, said method comprising the steps of contacting said matrix with a solution comprising a decontaminating agent or a detergent at pressure different from said predetermined value, and then maintaining said matrix in contact therewith for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 38
Independent Claim 130 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said high pressure washing condition including vigorous agitation sufficient to drive said decontaminating agent or detergent into internal matrices of the bone, said method comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to said high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites, said method further comprising an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent also having said aforementioned capability.
Claim 39
Independent Claim 130 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said high pressure washing condition including vigorous agitation sufficient to drive said decontaminating agent or detergent into internal matrices of the bone, said method comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to said high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites, said method further comprising an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent also having said aforementioned capability.
Claim 40
Independent Claim 47 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, wherein said high pressure washing condition comprising vigorous agitation.
Claim 41
Independent Claim 47 words
A method of providing bone suitable for transplantation into a human comprising the step of contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, wherein said high pressure washing condition comprising vigorous agitation.
Claim 42
Independent Claim 62 words
A method of preparing bone suitable for transplantation into a human comprising the step of contacting, at an elevated temperature and under a high pressure washing condition, internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said high pressure washing condition being sufficient to drive said decontaminating agent or detergent into internal matrix of the bone.
Claim 43
Independent Claim 62 words
A method of preparing bone suitable for transplantation into a human comprising the step of contacting, at an elevated temperature and under a high pressure washing condition, internal matrix of said bone with a solution comprising a decontaminating agent or a detergent, said high pressure washing condition being sufficient to drive said decontaminating agent or detergent into internal matrix of the bone.
Claim 44
Independent Claim 41 words
A method according to 35 comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to said high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites.
Claim 45
Independent Claim 41 words
A method according to 35 comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to said high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites.
Claim 46
Dependent Claim 41 words
A method according to claim 35 comprising also an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites.
Claim 47
Dependent Claim 74 words
A method according to claim 35 comprising also an additional step of contacting said bone, prior to subjecting said internal matrix thereof to said high pressure washing condition, with a decontaminating agent having the capability to inactivate bacteria, fungi, virus, or parasites, said method further comprising an additional step of contacting, subsequent to said high pressure washing condition, said bone and said internal matrix thereof with a decontaminating agent also having said aforementioned capability.
Claim 48
Dependent Claim 15 words
A method according to claim 35 wherein said high pressure washing condition comprises vigorous agitation.
Claim 49
Dependent Claim 14 words
A method according to claim 35 wherein said elevated temperature facilitates inactivation of virus.
Claim 50
Dependent Claim 18 words
A method according to claim 35 wherein said elevated temperature facilitates removal of fat from said internal matrix.
Claim 51
Dependent Claim 89 words
A method according to claim 35 wherein said bone utilized therein contains internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom, at a predetermined pressure, said method comprising the steps of first subjecting said matrix at an elevated temperature to pressure different from said predetermined value thereof, and then maintaining said matrix in contact with said pressure at said temperature of a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 52
Dependent Claim 101 words
A method according to claim 35 wherein, said bone utilized therein contains internal matrix having a predetermined amount of marrow, blood cells, or fat, or of debris therefrom, at a predetermined pressure, said method comprising the steps of contacting, at an elevated temperature and at a pressure above said predetermined value thereof, said matrix with a solution comprising a decontaminating agent or a detergent, and then maintaining said matrix in contact therewith, under said conditions of temperature and pressure, for a time effective to reduce said amount of marrow, cells, or fat, or of debris therefrom below said predetermined value thereof.
Claim 53
Dependent Claim 22 words
A method according to claim 35 wherein said high pressure washing is conducted at a temperature between about 37 and 80° C.
Claim 54
Dependent Claim 22 words
A method according to claim 35 wherein said high pressure washing is conducted at a temperature between about 37 and 60° C.

References Cited (Backward Citations)

GB964545A Cited
US4169123A Cited
US4526751A Cited
US4923677A Cited
US4946792A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1997-08-01 1998-01-31 1998-08-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2001-08-01 2002-01-31 2002-08-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2005-08-01 2006-01-31 2006-08-02 $7700.00 Window Closed / Lapsed

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