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US6356782B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Subcutaneous cavity marking device and method

Assignee: Devicor Medical Products Inc
•
Filing: 1999-04-02
•
Granted: 2002-03-12
•
Expires: 2019-04-02
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Abstract

Abstract These are subcutaneous cavity marking devices and methods. More particularly, upon insertion into a body, the cavity marking device and method enable one to determine the center, orientation, and periphery of the cavity by radiographic, mammographic, echogenic, or other non-invasive imaging techniques. Also, the device contains a bioabsorbable or non-bioabsorbable marker. The device may be combined with various substances enhancing the radiopaque, mammographic, or echogenic characteristics of the marker or the body allowing it to be observed by any non-invasive imaging techniques. This is further a method of marking a subcutaneous cavity using a bioabsorbable material and a bioabsorbable or non-bioabsorbable marker in conjunction with the material. The method also may combine any of the features as described with the device.

Inventors

  • 👤 D. Laksen Sirimanne
  • 👤 Douglas S. Sutton
  • 👤 Natalie V. Fawzi
  • 👤 Gail Lebovic

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 12:31
CPC Classifications
A; A61; A61B; A61B8/00; A61B8/48; A61B8/481; A61K; A61K49/00; A61K49/001; A61K49/006; A61B90/00; A61B90/39; A61K49/22; A61K49/222; A61B2090/3904; A61B2090/3908; A61B2090/3987

Claims Analysis

Total Claims: 115
Claim 1
Independent Claim 44 words
A subcutaneous cavity marking device comprising: (a) at least one filler body comprising a resilient bioabsorbable material, and (b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body, wherein said marker is mammographic.
Claim 2
Dependent Claim 44 words
A subcutaneous cavity marking device comprising: (a) at least one filler body comprising a resilient bioabsorbable material, and (b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body, wherein said marker is mammographic.
Claim 3
Dependent Claim 15 words
The device of claim 1 wherein the at least one marker comprises a non-bioabsorbable material.
Claim 4
Dependent Claim 31 words
The device of claim 2 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.
Claim 5
Dependent Claim 16 words
The device of claim 1 wherein the at least one marker comprises a second bioabsorbable material.
Claim 6
Dependent Claim 17 words
The device of claim 4 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.
Claim 7
Dependent Claim 31 words
The device of claim 5 wherein the radiopaque additive is selected from the group consisting of barium-containing compounds, bismuth-containing compounds, powdered tantalum, powdered tungsten, barium carbonate, bismuth oxide, and barium sulfate.
Claim 8
Dependent Claim 13 words
The device of claim 1 wherein the at least one marker is radiopaque.
Claim 9
Dependent Claim 13 words
The device of claim 1 wherein the at least one body is radiopaque.
Claim 10
Dependent Claim 13 words
The device of claim 1 wherein the at least one marker is echogenic.
Claim 11
Dependent Claim 13 words
The device of claim 1 wherein the at least one body is echogenic.
Claim 12
Dependent Claim 13 words
The device of claim 1 wherein the at least one body is mammographic.
Claim 13
Dependent Claim 13 words
The device of claim 1 wherein the at least one body is palpable.
Claim 14
Dependent Claim 22 words
The device of claim 12 wherein after insertion of said device into a patient said marker is not locatable by tactile detection.
Claim 15
Dependent Claim 19 words
The device of claim 1 wherein the marker is located within an interior of the at least one body.
Claim 16
Dependent Claim 21 words
The device of claim 1 wherein the marker is substantially located within a geometric center of the at least one body.
Claim 17
Dependent Claim 11 words
The device of claim 1 additionally comprising a pain killing substance.
Claim 18
Dependent Claim 10 words
The device of claim 1 additionally comprising a hemostatic substance.
Claim 19
Dependent Claim 24 words
The device of claim 1 wherein the bioabsorbable material is selected from the group consisting of collagen, regenerated cellulose, synthetic polymers and synthetic proteins.
Claim 20
Dependent Claim 14 words
The device of claim 1 wherein the marker has a form of a sphere.
Claim 21
Dependent Claim 10 words
The device of claim 19 wherein the sphere is hollow.
Claim 22
Dependent Claim 14 words
The device of claim 1 wherein the marker has a form of a band.
Claim 23
Dependent Claim 11 words
The device of claim 1 wherein the marker comprises a suture.
Claim 24
Dependent Claim 11 words
The device of claim 1 wherein the marker comprises a wire.
Claim 25
Dependent Claim 12 words
The device of claim 1 wherein the marker has a distinguishing mark.
Claim 26
Dependent Claim 17 words
The device of claim 1 wherein the marker is fixedly attached to the at least one body.
Claim 27
Dependent Claim 16 words
The device of claim 25 wherein the marker is woven to the at least one body.
Claim 28
Dependent Claim 10 words
The device of claim 1 wherein the marker is radioactive.
Claim 29
Dependent Claim 13 words
The device of claim 1 wherein the at least one body is radioactive.
Claim 30
Dependent Claim 14 words
The device of claim 1 wherein the at least one body is substantially spherical.
Claim 31
Dependent Claim 14 words
The device of claim 1 wherein the at least one body is substantially cylindrical.
Claim 32
Dependent Claim 17 words
The device of claim 1 wherein the at least one body is has a substantially irregular shape.
Claim 33
Dependent Claim 16 words
The device of claim 1 wherein the at least one body comprises a plurality of pores.
Claim 34
Dependent Claim 18 words
The device of claim 32 wherein the pores are configured to promote tissue growth in a preferred orientation.
Claim 35
Dependent Claim 17 words
The device of claim 1 wherein the at least one filler body additionally comprises a bio-compatible liquid.
Claim 36
Dependent Claim 14 words
The device of claim 1 wherein said filler body further comprises a palpable shell.
Claim 37
Dependent Claim 28 words
The device of claim 35 wherein said shell is bioabsorbable and degrades when implanted within a patient's body, after said shell degrades said shell is no longer palpable.
Claim 38
Dependent Claim 17 words
The device of claim 36 wherein said shell is configured to degrade over a period of time.
Claim 39
Dependent Claim 15 words
The device of claim 37 wherein said period of time is less than 1 year.
Claim 40
Dependent Claim 16 words
The device of claim 37 wherein said period of time is between 2 and 6 months.
Claim 41
Dependent Claim 14 words
The device of claim 37 wherein said period of time is about 3 months.
Claim 42
Dependent Claim 16 words
The device of claim 1 wherein after a period of time said body is not palpable.
Claim 43
Dependent Claim 14 words
The device of claim 41 wherein said period of time is approximately 3 months.
Claim 44
Dependent Claim 47 words
A subcutaneous cavity marking device comprising: (a) at least one filler body comprising a resilient bioabsorbable material, wherein the at least one body is mammographic, and (b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body.
Claim 45
Dependent Claim 47 words
A subcutaneous cavity marking device comprising: (a) at least one filler body comprising a resilient bioabsorbable material, wherein the at least one body is mammographic, and (b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body.
Claim 46
Dependent Claim 15 words
The device of claim 43 wherein the at least one marker comprises a non-bioabsorbable material.
Claim 47
Dependent Claim 31 words
The device of claim 44 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.
Claim 48
Dependent Claim 16 words
The device of claim 43 wherein the at least one marker comprises a second bioabsorbable material.
Claim 49
Dependent Claim 17 words
The device of claim 46 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.
Claim 50
Dependent Claim 31 words
The device of claim 47 wherein the radiopaque additive is selected from the group consisting of barium-containing compounds, bismuth-containing compounds, powdered tantalum, powdered tungsten, barium carbonate, bismuth oxide, and barium sulfate.
Claim 51
Dependent Claim 13 words
The device of claim 43 wherein the at least one marker is radiopaque.
Claim 52
Dependent Claim 13 words
The device of claim 43 wherein the at least one body is radiopaque.
Claim 53
Dependent Claim 13 words
The device of claim 43 wherein the at least one marker is echogenic.
Claim 54
Dependent Claim 13 words
The device of claim 43 wherein the at least one body is echogenic.
Claim 55
Dependent Claim 13 words
The device of claim 43 wherein the at least one body is palpable.
Claim 56
Dependent Claim 21 words
The device of claim 53 wherein after insertion of said device into apatient said marker is not locatable by tactile detection.
Claim 57
Dependent Claim 19 words
The device of claim 43 wherein the marker is located within an interior of the at least one body.
Claim 58
Dependent Claim 21 words
The device of claim 43 wherein the marker is substantially located within a geometric center of the at least one body.
Claim 59
Dependent Claim 11 words
The device of claim 43 additionally comprising a pain killing substance.
Claim 60
Dependent Claim 10 words
The device of claim 43 additionally comprising a hemostatic substance.
Claim 61
Dependent Claim 24 words
The device of claim 43 wherein the bioabsorbable material is selected from the group consisting of collagen, regenerated cellulose, synthetic polymers and synthetic proteins.
Claim 62
Dependent Claim 14 words
The device of claim 43 wherein the marker has a form of a sphere.
Claim 63
Dependent Claim 10 words
The device of claim 60 wherein the sphere is hollow.
Claim 64
Dependent Claim 14 words
The device of claim 43 wherein the marker has a form of a band.
Claim 65
Dependent Claim 11 words
The device of claim 43 wherein the marker comprises a suture.
Claim 66
Dependent Claim 11 words
The device of claim 43 wherein the marker comprises a wire.
Claim 67
Dependent Claim 12 words
The device of claim 43 wherein the marker has a distinguishing mark.
Claim 68
Dependent Claim 17 words
The device of claim 43 wherein the marker is fixedly attached to the at least one body.
Claim 69
Dependent Claim 16 words
The device of claim 66 wherein the marker is woven to the at least one body.
Claim 70
Dependent Claim 10 words
The device of claim 43 wherein the marker is radioactive.
Claim 71
Dependent Claim 13 words
The device of claim 43 wherein the at least one body is radioactive.
Claim 72
Dependent Claim 14 words
The device of claim 43 wherein the at least one body is substantially spherical.
Claim 73
Dependent Claim 14 words
The device of claim 43 wherein the at least one body is substantially cylindrical.
Claim 74
Dependent Claim 17 words
The device of claim 43 wherein the at least one body is has a substantially irregular shape.
Claim 75
Dependent Claim 16 words
The device of claim 43 wherein the at least one body comprises a plurality of pores.
Claim 76
Dependent Claim 18 words
The device of claim 73 wherein the pores are configured to promote tissue growth in a preferred orientation.
Claim 77
Dependent Claim 17 words
The device of claim 43 wherein the at least one filler body additionally comprises a bio-compatible liquid.
Claim 78
Dependent Claim 14 words
The device of claim 43 wherein said filler body further comprises a palpable shell.
Claim 79
Dependent Claim 28 words
The device of claim 76 wherein said shell is bioabsorbable and degrades when implanted within a patient's body, after said shell degrades said shell is no longer palpable.
Claim 80
Dependent Claim 17 words
The device of claim 77 wherein said shell is configured to degrade over a period of time.
Claim 81
Dependent Claim 15 words
The device of claim 78 wherein said period of time is less than 1 year.
Claim 82
Dependent Claim 16 words
The device of claim 78 wherein said period of time is between 2 and 6 months.
Claim 83
Dependent Claim 14 words
The device of claim 78 wherein said period of time is about 3 months.
Claim 84
Dependent Claim 16 words
The device of claim 43 wherein after a period of time said body is not palpable.
Claim 85
Dependent Claim 14 words
The device of claim 82 wherein said period of time is approximately 3 months.
Claim 86
Independent Claim 86 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) subcutaneously accessing the cavity via a delivery device, (b) introducing a biocompatible liquid in a remotely-detectable marker having a predetermined shape; and thereafter (c) deploying the marker through the delivery device into the cavity, wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.
Claim 87
Independent Claim 86 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) subcutaneously accessing the cavity via a delivery device, (b) introducing a biocompatible liquid in a remotely-detectable marker having a predetermined shape; and thereafter (c) deploying the marker through the delivery device into the cavity, wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.
Claim 88
Dependent Claim 10 words
The method of claim 84 wherein the marker is bioabsorbable.
Claim 89
Dependent Claim 10 words
The method of claim 84 wherein the marker is radiopaque.
Claim 90
Dependent Claim 10 words
The method of claim 84 wherein the marker is echogenic.
Claim 91
Dependent Claim 11 words
The method of claim 84 wherein the marker comprises a wire.
Claim 92
Dependent Claim 13 words
The method of claim 85 wherein the wire comprises a shape memory material.
Claim 93
Dependent Claim 31 words
The method of claim 84 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.
Claim 94
Dependent Claim 14 words
The method of claim 84 wherein the marker is capable of emitting radioactive energy.
Claim 95
Dependent Claim 12 words
The method of claim 84 wherein the marker is a helical coil.
Claim 96
Dependent Claim 24 words
The method of claim 84 wherein the marker defines a volume having a substantially spherical shape when the marker is deployed inside the cavity.
Claim 97
Dependent Claim 24 words
The method of claim 84 wherein the marker defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.
Claim 98
Dependent Claim 23 words
The method of claim 84 wherein the marker defines a volume comprising a random shape when the marker is deployed inside the cavity.
Claim 99
Dependent Claim 17 words
The method of claim 84 wherein the delivery device uses a hydraulic force to deploy the marker.
Claim 100
Dependent Claim 13 words
The method of claim 84 wherein the delivery device comprises a biopsy device.
Claim 101
Independent Claim 87 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) subcutaneously accessing the cavity via a delivery device, (b) deploying a remotely detectable marker having a predetermined shape through the delivery device into the cavity, and thereafter (c) introducing a biocompatible liquid in the marker, wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.
Claim 102
Independent Claim 87 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) subcutaneously accessing the cavity via a delivery device, (b) deploying a remotely detectable marker having a predetermined shape through the delivery device into the cavity, and thereafter (c) introducing a biocompatible liquid in the marker, wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.
Claim 103
Dependent Claim 18 words
The method of claim 98 wherein the bio-compatible liquid is introduced to the marker via the delivery device.
Claim 104
Dependent Claim 10 words
The method of claim 98 wherein the marker is bioabsorbable.
Claim 105
Dependent Claim 10 words
The method of claim 98 wherein the marker is radiopaque.
Claim 106
Dependent Claim 10 words
The method of claim 98 wherein the marker is echogenic.
Claim 107
Dependent Claim 11 words
The method of claim 98 wherein the marker comprises a wire.
Claim 108
Dependent Claim 13 words
The method of claim 103 wherein the wire comprises a shape memory material.
Claim 109
Dependent Claim 31 words
The method of claim 104 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.
Claim 110
Dependent Claim 14 words
The method of claim 104 wherein the marker is capable of emitting radioactive energy.
Claim 111
Dependent Claim 12 words
The method of claim 104 wherein the marker is a helical coil.
Claim 112
Dependent Claim 24 words
The method of claim 104 wherein the marker defines a volume having a substantially spherical shape when the marker is deployed inside the cavity.
Claim 113
Dependent Claim 24 words
The method of claim 104 wherein the marker defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.
Claim 114
Dependent Claim 23 words
The method of claim 104 wherein the marker defines a volume comprising a random shape when the marker is deployed inside the cavity.
Claim 115
Dependent Claim 13 words
The method of claim 104 wherein the delivery device comprises a biopsy device.

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2005-03-11 2005-09-10 2006-03-12 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2009-03-11 2009-09-10 2010-03-12 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2013-03-11 2013-09-10 2014-03-12 $7700.00 Window Closed / Lapsed

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