US6161034A
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US
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Methods and chemical preparations for time-limited marking of biopsy sites
Assignee: SenoRx Inc
•
Filing: 1999-02-02
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Granted: 2000-12-12
•
Expires: 2019-02-02
Abstract
Abstract Detectable markers that may be introduced into a cavity created by removal of a biopsy specimen to mark the location of the biopsy site so that it may be located in a subsequent medical/surgical procedure. The markers remain present in sufficient quantity to permit detection and location of the biopsy site at a first time point (e.g., 2 weeks) after introduction but clear from the biopsy site or otherwise not interfere with imaging of tissues adjacent the biopsy site at a second time point (e.g., 5-7 months) after introduction.
Inventors
- 👤 Fred H. Burbank
- 👤 Paul Lubock
- 👤 Michael L. Jones
- 👤 Nancy Forcier
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 06:20
CPC Classifications
A; A61; A61B; A61B90/00; A61B90/39; A61K; A61K49/00; A61K49/001; A61K49/006; A61M; A61M37/00; A61M37/0069; A61B10/00; A61B10/02; A61B17/00; A61B2017/00004; A61B90/36; A61B90/37; A61B2090/378; A61B2090/3782; A61B2090/3788; A61B2090/3904; A61B2090/3908; A61B2090/3925; A61B2090/3929; A61B2090/3933; A61B2090/3937; A61B2090/395; A61B2090/397; A61B2090/3975; A61B2090/3987; A61B2090/3995
Claims Analysis
Total Claims: 43
Claim 1
Independent Claim
83 words
A method for marking a site within the body of a mammalian patient from which a tissue sample has been removed, said method comprising the step of: A. introducing into the site a detectable marker that (i) remains present at the site in sufficient quantity to permit detection and location of the site for at least a predetermined first time period after introduction and (ii) does not interfere with imaging of tissue adjacent the site at a predetermined second time point after introduction.
Claim 2
Independent Claim
83 words
A method for marking a site within the body of a mammalian patient from which a tissue sample has been removed, said method comprising the step of: A. introducing into the site a detectable marker that (i) remains present at the site in sufficient quantity to permit detection and location of the site for at least a predetermined first time period after introduction and (ii) does not interfere with imaging of tissue adjacent the site at a predetermined second time point after introduction.
Claim 3
Dependent Claim
62 words
The method of claim 1 wherein the detectable marker is imageable, and wherein the marker remains present at the site in sufficient quantity to allow detection of the site by imaging of the marker at said first time point but clears sufficiently from the site so as to not interfere with imaging of tissue adjacent the site at said second time point.
Claim 4
Dependent Claim
40 words
The method of claim 2 wherein the imaging method by which the detectable marker is selected from the group of imaging methods consisting of: X-ray; fluoroscopy; mammography; computed tomography; magnetic resonance imaging; ultrasound; Doppler, radiation detector; and, possible combinations thereof.
Claim 5
Dependent Claim
12 words
The method of claim 1 wherein the marker is detectable by palpation.
Claim 6
Dependent Claim
42 words
The method of claim 4 wherein the palpable marker is selected from the group consisting of: at least one balloon; at least one bead; a flowable space occupying material; a collagenous material, a gelatinous material; gelatin; cross-linked gelatin; and, possible combinations thereof.
Claim 7
Dependent Claim
11 words
The method of claim 1 wherein the marker is visually detectable.
Claim 8
Dependent Claim
31 words
The method of claim 6 wherein the visually detectable marker is a colored substance selected from the group consisting of: a dye; a colorant; colorant particles; carbon; and, possible combinations thereof.
Claim 9
Dependent Claim
37 words
The method of claim 1 wherein the detectable marker is detectable by a detection method selected from the group consisting of: imaging of the marker; palpation of the marker; visualization of the marker; and, possible combinations thereof.
Claim 10
Dependent Claim
70 words
The method of claim 1 wherein the detectable marker introduced in Step A comprises: a detectable material that will interfere with imaging of tissues adjacent thereto and which remains present at the site in sufficient quantity to permit location of the site by imaging until the first time point but clears sufficiently from the site to not interfere with imaging of tissue adjacent the site at said second time point.
Claim 11
Dependent Claim
121 words
The method of claim 1 wherein the detectable marker introduced in Step A comprises: a quantity of detectable material that, if introduced into the site alone, would clear from the site such that a detectable quantity of the marker would no longer be present at the site at 2 weeks after introduction of said detectable marker; and, a clearance delaying element that delays the clearance of said material from the site such that (i) a detectable quantity of said material remains present at the site until at least said first time point and (ii) said material clears sufficiently from the site to permit imaging of tissue adjacent to the site without interference from said detectable marker at said second time point.
Claim 12
Dependent Claim
30 words
The method of claim 9 wherein the detectable material is a chemical compound that has a solubility constant of less than 1×10 -3 grams per 100 cubic centimeters of water.
Claim 13
Dependent Claim
39 words
The method of claim 11 wherein said chemical compound is selected from the group consisting of: AgCl; Agl; BaCO 3 ; BaSO 4 ; K; CaCO 3 ; ZnO; Al 2 O 3 ; and, the possible combinations thereof.
Claim 14
Dependent Claim
37 words
The method of claim 10 wherein the detectable material is selected from the group consisting of: AGNO 3 ; ammonium salts; sodium salts; potassium salts; ethiodized oil; isohexol; isopamidol; gas; lipid; oil; and, the possible combinations thereof.
Claim 15
Dependent Claim
42 words
The method of claim 10 wherein the clearance delaying element is selected from the group consisting of: polylactic acid; polyglycolic acid; polycapriolactone; an encapsulating material; collagen renatured collagen; gelatin; renatured gelatin; crosslinked gelatin; a balloon; a microsphere; and the possible combinations thereof.
Claim 16
Dependent Claim
19 words
The method of claim 1 wherein the detectable marker comprises a material that is detectable by radiographic imaging means.
Claim 17
Dependent Claim
19 words
The method of claim 1 wherein the detectable marker comprises a material that is detectable by sonographic imaging means.
Claim 18
Dependent Claim
19 words
The method of claim 1 wherein the detectable marker comprises a material that is detectable by magnetic imaging means.
Claim 19
Dependent Claim
13 words
The method of claim 1 wherein the detectable marker comprises a dry powder.
Claim 20
Dependent Claim
12 words
The method of claim 1 wherein the detectable marker comprises a sponge.
Claim 21
Dependent Claim
12 words
The method of claim 1 wherein the detectable marker comprises a suspension.
Claim 22
Dependent Claim
12 words
The method of claim 1 wherein the detectable marker comprises a slurry.
Claim 23
Dependent Claim
19 words
The method of claim 1 wherein the detectable marker comprises a collagenous material having radiographically imageable matter attached thereto.
Claim 24
Dependent Claim
15 words
The method of claim 22 wherein the collagenous material of the marker comprises renatured collagen.
Claim 25
Dependent Claim
13 words
The method of claim 23 wherein the collagenous material is also covalently crosslinked.
Claim 26
Dependent Claim
13 words
The method of claim 22 wherein the radiographically imageable matter comprises metal ions.
Claim 27
Dependent Claim
13 words
The method of claim 22 wherein the radiographically imageable matter comprises a gas.
Claim 28
Dependent Claim
33 words
The method of claim 22 wherein the collagenous material of the marker comprises renatured collagen and the radiographically imageable matter of the marker comprises metal ions that are bound to said renatured collagen.
Claim 29
Dependent Claim
12 words
The method of claim 25 wherein the metal ions are silver ions.
Claim 30
Dependent Claim
39 words
A method according to claim 28 wherein the marker is prepared by a process that comprises: a. obtaining a quantity of denatured collagenous material; b. renaturing the collagenous material; and, c. binding metal ions to the renatured collagenous material.
Claim 31
Dependent Claim
39 words
A method according to claim 26 wherein the marker is prepared by a process that comprises: a. obtaining a quantity of denatured collagenous material; b. renaturing the collagenous material; and, c. dispersing a gas throughout the renatured collagenous material.
Claim 32
Dependent Claim
19 words
The method of claim 22 wherein the decectable marker comprises a gelatinous material having radiographically imageable matter combined therewith.
Claim 33
Dependent Claim
15 words
The method of claim 31 wherein the gelatinous material of the marker comprises renatured gelatin.
Claim 34
Dependent Claim
13 words
The method of claim 32 wherein the gelatinous material is also covalently crosslinked.
Claim 35
Dependent Claim
13 words
The method of claim 31 wherein the radiographically imageable matter comprises metal ions.
Claim 36
Dependent Claim
13 words
The method of claim 31 wherein the radiographically imageable matter comprises a gas.
Claim 37
Dependent Claim
33 words
The method of claim 31 wherein the gelatinous material of the marker comprises renatured gelatin and the radiographically imageable matter of the marker comprises metal ions that are bound to said renatured gelatin.
Claim 38
Dependent Claim
12 words
The method of claim 34 wherein the metal ions are silver ions.
Claim 39
Dependent Claim
35 words
The method of claim 29 wherein the marker is prepared by a process that comprises: d. obtaining a quantity of denatured gelatin; e. renaturing the gelatin; and, f. binding metal ions to the renatured gelatin.
Claim 40
Dependent Claim
34 words
The method of claim 30 wherein the marker is prepared by a process that comprises: d. obtaining a quantity of denatured gelatin; e. renaturing the gelatin; and, f. dispersing gas throughout the renatured gelatin.
Claim 41
Independent Claim
111 words
A method of identifying tissue that is located within a predetermined distance of a boundary of a biopsy cavity that has been created by the removal of a biopsy specimen from a patient, said method comprising the steps of: a. introducing into the biopsy cavity a quantity of marker material that is visibly distinguishable from blood and surrounding tissue so as to delineate the outer boundaries of the biopsy cavity; b. forming an incision in the patient to permit visualization of the marker material and the boundaries of the biopsy cavity delineated thereby; and, c. identifying the tissue that lies within said predetermined distance of the boundary of the biopsy cavity.
Claim 42
Independent Claim
111 words
A method of identifying tissue that is located within a predetermined distance of a boundary of a biopsy cavity that has been created by the removal of a biopsy specimen from a patient, said method comprising the steps of: a. introducing into the biopsy cavity a quantity of marker material that is visibly distinguishable from blood and surrounding tissue so as to delineate the outer boundaries of the biopsy cavity; b. forming an incision in the patient to permit visualization of the marker material and the boundaries of the biopsy cavity delineated thereby; and, c. identifying the tissue that lies within said predetermined distance of the boundary of the biopsy cavity.
Claim 43
Dependent Claim
53 words
The method of claim 40 wherein it is desired to remove the tissue that lies within said predetermined distance of a boundary of the biopsy cavity and wherein the method further comprises the step of: d) excising and removing tissue that lies within said predetermined distance of the boundary of the biopsy cavity.
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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) | 2003-12-12 | 2004-06-12 | 2004-12-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-12-12 | 2008-06-12 | 2008-12-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-12-12 | 2012-06-12 | 2012-12-12 | $7700.00 | Window Closed / Lapsed |