US6371904B1
Expired / Lapsed
US
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Subcutaneous cavity marking device and method
Assignee: Devicor Medical Products Inc
•
Filing: 1999-07-02
•
Granted: 2002-04-16
•
Expires: 2019-07-02
Abstract
Abstract This is a 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
- 👤 Natalie V. Fawzi
- 👤 Douglas S. Sutton
- 👤 Gail Lebovic
- 👤 Stanley R. Conston
- 👤 Peter M. Wilson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:11
CPC Classifications
A; A61; A61K; A61K49/00; A61K49/001; A61K49/006; A61B; A61B17/00; A61B2017/00535; A61B2017/00539; A61B90/00; A61B90/39; A61B2090/3925; A61B2090/3966; A61B2090/3987; A61B2090/3995
Claims Analysis
Total Claims: 108
Claim 1
Independent Claim
43 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the at least one body is palpable when implanted in the subcutaneous cavity.
Claim 2
Dependent Claim
43 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the at least one body is palpable when implanted in the subcutaneous cavity.
Claim 3
Dependent Claim
37 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the marker has a substantially spherical form.
Claim 4
Dependent Claim
37 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the marker has a substantially spherical form.
Claim 5
Dependent Claim
10 words
The device of claim 2 wherein the sphere is hollow.
Claim 6
Dependent Claim
87 words
A cavity marking delivery device comprising: (a) a disengaging arm having a distal and a proximal end; (b) a cartridge having a delivery lumen, said cartridge being slidable upon said disengaging arm and having a fixable position between said distal and proximal ends of said disengaging arm, said cartridge having an end portion extending beyond said distal end of said disengaging arm when said cartridge is placed in said fixable position; and (c) a cavity marking device locatable within said delivery lumen adjacent to said end portion.
Claim 7
Dependent Claim
87 words
A cavity marking delivery device comprising: (a) a disengaging arm having a distal and a proximal end; (b) a cartridge having a delivery lumen, said cartridge being slidable upon said disengaging arm and having a fixable position between said distal and proximal ends of said disengaging arm, said cartridge having an end portion extending beyond said distal end of said disengaging arm when said cartridge is placed in said fixable position; and (c) a cavity marking device locatable within said delivery lumen adjacent to said end portion.
Claim 8
Dependent Claim
48 words
The delivery device of claim 4 where said cartridge has a proximal position adjacent to said proximal end of said disengaging arm, where said end portion of said cartridge is substantially adjacent to said distal end of said disengaging arm when said cartridge is in said proximal position.
Claim 9
Dependent Claim
15 words
The delivery device of claim 4 further comprising a sheath removably locatable about said cartridge.
Claim 10
Dependent Claim
31 words
The delivery device of claim 6 wherein said sheath has a fixable position along said cartridge between said distal end of said disengaging arm and said fixable position of said cartridge.
Claim 11
Dependent Claim
22 words
The delivery device of claim 4 wherein said cavity marking device is configured to have a significant frictional fit within said cartridge.
Claim 12
Dependent Claim
30 words
A subcutaneous cavity marking device kit comprising the cavity marking delivery device of claim 4 and wherein said cavity marking device comprises a bioabsorbable filler body comprising a thread-like material.
Claim 13
Independent Claim
117 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) introducing a sheath over a delivery device; (b) introducing the sheath and the delivery device into communication with the cavity; (c) inserting a remotely detectable marker into a cartridge; (d) advancing the cartridge into the delivery device until a portion of the cartridge containing the marker is in a desired position; and (e) retracting the cartridge from the cavity independently of the marker to deploy the marker into the cavity wherein 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 14
Independent Claim
117 words
A method of marking a tissue cavity having a margin in a mammalian body, comprising: (a) introducing a sheath over a delivery device; (b) introducing the sheath and the delivery device into communication with the cavity; (c) inserting a remotely detectable marker into a cartridge; (d) advancing the cartridge into the delivery device until a portion of the cartridge containing the marker is in a desired position; and (e) retracting the cartridge from the cavity independently of the marker to deploy the marker into the cavity wherein 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 15
Dependent Claim
10 words
The method of claim 10 wherein the marker is bioabsorbable.
Claim 16
Dependent Claim
10 words
The method of claim 10 wherein the marker is radiopaque.
Claim 17
Dependent Claim
10 words
The method of claim 10 wherein the marker is echogenic.
Claim 18
Dependent Claim
11 words
The method of claim 10 wherein the marker comprises a wire.
Claim 19
Dependent Claim
31 words
The method of claim 10 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 20
Dependent Claim
14 words
The method of claim 10 wherein the marker is capable of emitting radioactive energy.
Claim 21
Dependent Claim
12 words
The method of claim 10 wherein the marker is a helical coil.
Claim 22
Dependent Claim
24 words
The method of claim 10 wherein the marker defines a volume having a substantially spherical shape when the marker is deployed inside the cavity.
Claim 23
Dependent Claim
24 words
The method of claim 10 wherein the marker defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.
Claim 24
Dependent Claim
23 words
The method of claim 10 wherein the marker defines a volume comprising a random shape when the marker is deployed inside the cavity.
Claim 25
Dependent Claim
13 words
The method of claim 14 wherein the wire comprises a shape memory material.
Claim 26
Dependent Claim
25 words
The method of claim 10 further comprising the step of introducing a bio-compatible liquid in the marker prior to the step of deploying the marker.
Claim 27
Dependent Claim
17 words
The method of claim 22 wherein the delivery device uses a hydraulic force to deploy the marker.
Claim 28
Dependent Claim
25 words
The method of claim 10 further comprising the step of introducing a bio-compatible liquid in the marker subsequent to the step of deploying the marker.
Claim 29
Dependent Claim
18 words
The method of claim 24 wherein the bio-compatible liquid is introduced to the marker via the delivery device.
Claim 30
Dependent Claim
38 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the marker has a form of a band.
Claim 31
Dependent Claim
38 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein the marker has a form of a band.
Claim 32
Dependent Claim
15 words
The device of claim 26 wherein the at least one marker comprises a non-bioabsorbable material.
Claim 33
Dependent Claim
31 words
The device of claim 27 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 34
Dependent Claim
16 words
The device of claim 26 wherein the at least one marker comprises a second bioabsorbable material.
Claim 35
Dependent Claim
17 words
The device of claim 29 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.
Claim 36
Dependent Claim
31 words
The device of claim 30 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 37
Dependent Claim
13 words
The device of claim 26 wherein the at least one marker is radiopaque.
Claim 38
Dependent Claim
13 words
The device of claim 26 wherein the at least one body is radiopaque.
Claim 39
Dependent Claim
13 words
The device of claim 26 wherein the at least one marker is echogenic.
Claim 40
Dependent Claim
13 words
The device of claim 26 wherein the at least one body is echogenic.
Claim 41
Dependent Claim
13 words
The device of claim 26 wherein the at least one marker is mammographic.
Claim 42
Dependent Claim
13 words
The device of claim 26 wherein the at least one body is mammographic.
Claim 43
Dependent Claim
19 words
The device of claim 26 wherein the at least one body is palpable when implanted in the subcutaneous cavity.
Claim 44
Dependent Claim
19 words
The device of claim 26 wherein the marker is located within an interior of the at least one body.
Claim 45
Dependent Claim
21 words
The device of claim 26 wherein the marker is substantially located within a geometric center of the at least one body.
Claim 46
Dependent Claim
11 words
The device of claim 26 additionally comprising a pain killing substance.
Claim 47
Dependent Claim
10 words
The device of claim 26 additionally comprising a hemostatic substance.
Claim 48
Dependent Claim
13 words
The device of claim 26 wherein the bioabsorbable material comprises a synthetic polymer.
Claim 49
Dependent Claim
23 words
The device of claim 43 wherein said synthetic polymer is chosen from the group consisting of poly ε-caprolactone, PGA, PLA, and copolymers thereof.
Claim 50
Dependent Claim
11 words
The device of claim 26 wherein the marker comprises a suture.
Claim 51
Dependent Claim
11 words
The device of claim 26 wherein the marker comprises a wire.
Claim 52
Dependent Claim
12 words
The device of claim 26 wherein the marker has a distinguishing mark.
Claim 53
Dependent Claim
17 words
The device of claim 26 wherein the marker is fixedly attached to the at least one body.
Claim 54
Dependent Claim
16 words
The device of claim 48 wherein the marker is woven to the at least one body.
Claim 55
Dependent Claim
10 words
The device of claim 26 wherein the marker is radioactive.
Claim 56
Dependent Claim
13 words
The device of claim 26 wherein the at least one body is radioactive.
Claim 57
Dependent Claim
14 words
The device of claim 26 wherein the at least one body is substantially spherical.
Claim 58
Dependent Claim
14 words
The device of claim 26 wherein the at least one body is substantially cylindrical.
Claim 59
Dependent Claim
17 words
The device of claim 26 wherein the at least one body is has a substantially irregular shape.
Claim 60
Dependent Claim
14 words
The device of claim 26 where said bioabsorbable thread-like material is a suture material.
Claim 61
Dependent Claim
22 words
The device of claim 26 where said thread-like material passes through the at least one marker and forms at least one loop.
Claim 62
Dependent Claim
27 words
The device of claim 56 where each said loop is longitudinally folded forming an opposing member located at an end of the loop opposite to the marker.
Claim 63
Dependent Claim
25 words
The device of claim 56 where said thread-like material passes through the at least one marker and forms at least one pair of opposing loops.
Claim 64
Dependent Claim
23 words
The device of claim 58 where said thread-like material passes through the at least one marker and forms two pairs of opposing loops.
Claim 65
Dependent Claim
34 words
The device of claim 58 where each loop of the pair of loops is longitudinally folded, said folded loop forming an opposing member located at an end of the loop opposite to the marker.
Claim 66
Dependent Claim
34 words
The subcutaneous cavity marking device of claim 26 wherein said at least one filler body comprises a plurality of filler bodies, at least two of which are connected by said at least one marker.
Claim 67
Dependent Claim
11 words
The device of claim 26 wherein said thread-like material is resilient.
Claim 68
Dependent Claim
14 words
The device of claim 62 wherein said resilient thread-like material has a preferred shape.
Claim 69
Dependent Claim
17 words
The device of claim 63 wherein said resilient thread-like material was heated to set said preferred shape.
Claim 70
Dependent Claim
35 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein said thread-like material is resilient.
Claim 71
Dependent Claim
35 words
A subcutaneous cavity marking device comprising: (a) at least one bioabsorbable filler body comprising a thread-like material, and (b) at least one detectable marker attached to said filler body, wherein said thread-like material is resilient.
Claim 72
Dependent Claim
14 words
The device of claim 65 wherein said resilient thread-like material has a preferred shape.
Claim 73
Dependent Claim
17 words
The device of claim 66 wherein said resilient thread-like material was heated to set said preferred shape.
Claim 74
Dependent Claim
15 words
The device of claim 65 wherein the at least one marker comprises a non-bioabsorbable material.
Claim 75
Dependent Claim
31 words
The device of claim 68 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 76
Dependent Claim
16 words
The device of claim 65 wherein the at least one marker comprises a second bioabsorbable material.
Claim 77
Dependent Claim
17 words
The device of claim 70 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.
Claim 78
Dependent Claim
31 words
The device of claim 71 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 79
Dependent Claim
13 words
The device of claim 65 wherein the at least one marker is radiopaque.
Claim 80
Dependent Claim
13 words
The device of claim 65 wherein the at least one body is radiopaque.
Claim 81
Dependent Claim
13 words
The device of claim 65 wherein the at least one marker is echogenic.
Claim 82
Dependent Claim
13 words
The device of claim 65 wherein the at least one body is echogenic.
Claim 83
Dependent Claim
13 words
The device of claim 65 wherein the at least one marker is mammographic.
Claim 84
Dependent Claim
13 words
The device of claim 65 wherein the at least one body is mammographic.
Claim 85
Dependent Claim
19 words
The device of claim 65 wherein the at least one body is palpable when implanted in the subcutaneous cavity.
Claim 86
Dependent Claim
19 words
The device of claim 65 wherein the marker is located within an interior of the at least one body.
Claim 87
Dependent Claim
21 words
The device of claim 65 wherein the marker is substantially located within a geometric center of the at least one body.
Claim 88
Dependent Claim
11 words
The device of claim 65 additionally comprising a pain killing substance.
Claim 89
Dependent Claim
10 words
The device of claim 65 additionally comprising a hemostatic substance.
Claim 90
Dependent Claim
13 words
The device of claim 65 wherein the bioabsorbable material comprises a synthetic polymer.
Claim 91
Dependent Claim
23 words
The device of claim 84 wherein said synthetic polymer is chosen from the group consisting of poly ε-caprolactone, PGA, PLA, and copolymers thereof.
Claim 92
Dependent Claim
11 words
The device of claim 65 wherein the marker comprises a suture.
Claim 93
Dependent Claim
11 words
The device of claim 65 wherein the marker comprises a wire.
Claim 94
Dependent Claim
12 words
The device of claim 65 wherein the marker has a distinguishing mark.
Claim 95
Dependent Claim
17 words
The device of claim 65 wherein the marker is fixedly attached to the at least one body.
Claim 96
Dependent Claim
16 words
The device of claim 89 wherein the marker is woven to the at least one body.
Claim 97
Dependent Claim
10 words
The device of claim 65 wherein the marker is radioactive.
Claim 98
Dependent Claim
13 words
The device of claim 65 wherein the at least one body is radioactive.
Claim 99
Dependent Claim
14 words
The device of claim 65 wherein the at least one body is substantially spherical.
Claim 100
Dependent Claim
14 words
The device of claim 65 wherein the at least one body is substantially cylindrical.
Claim 101
Dependent Claim
17 words
The device of claim 65 wherein the at least one body is has a substantially irregular shape.
Claim 102
Dependent Claim
14 words
The device of claim 65 where said bioabsorbable thread-like material is a suture material.
Claim 103
Dependent Claim
22 words
The device of claim 65 where said thread-like material passes through the at least one marker and forms at least one loop.
Claim 104
Dependent Claim
27 words
The device of claim 97 where each said loop is longitudinally folded forming an opposing member located at an end of the loop opposite to the marker.
Claim 105
Dependent Claim
25 words
The device of claim 65 where said thread-like material passes through the at least one marker and forms at least one pair of opposing loops.
Claim 106
Dependent Claim
23 words
The device of claim 99 where said thread-like material passes through the at least one marker and forms two pairs of opposing loops.
Claim 107
Dependent Claim
34 words
The device of claim 99 where each loop of the pair of loops is longitudinally folded, said folded loop forming an opposing member located at an end of the loop opposite to the marker.
Claim 108
Dependent Claim
34 words
The subcutaneous cavity marking device of claim 65 wherein said at least one filler body comprises a plurality of filler bodies, at least two of which are connected by said at least one marker.
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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) | 2005-04-15 | 2005-10-15 | 2006-04-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-04-15 | 2009-10-15 | 2010-04-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-04-15 | 2013-10-15 | 2014-04-16 | $7700.00 | Window Closed / Lapsed |