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US20040030262A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Biodegradable polymer for marking tissue and sealing tracts

Assignee: Med Genesis LLC
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Filing: 2002-05-03
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Granted: —
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Expires: 2022-05-03
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Abstract

Abstract A tissue marker formed of a biodegradable polymer having drug-delivery capabilities is combined with a sealant that encapsulates the tissue marker and which serves to help anchor the tissue marker against migration. The sealant is delivered to a site in dehydrated form and moisture inherent in tissue at the site expands the sealant. The expanded sealant is formed of a hydrogel and is therefore more compatible to the surrounding tissue than the material of the tissue marker. The sealant and the tissue marker are both bioabsorbed over time.

Inventors

  • 👤 John Fisher
  • 👤 Frederick Ahari
  • 👤 Lucjan Hronowski

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:17
CPC Classifications
A; A61; A61L; A61L24/00; A61L24/001; A61L24/0042; A61B; A61B90/00; A61B90/39; A61L24/0015; A61L24/0031; A61L31/00; A61L31/14; A61L31/18; A61B17/00; A61B2017/00004; A61B2017/00831; A61B2017/00893; A61B2017/00898; A61L2300/00; A61L2300/40; A61L2300/404; A61L2300/406; A61L2300/41; A61L2300/416; A61L2300/44; A61L2300/60; A61L2300/602; A61L2300/604

Claims Analysis

Total Claims: 60
Claim 1
Independent Claim 36 words
1 . A combination tissue marker polymer and sealant, wherein said tissue marker polymer is formed of a biodegradable polymer and wherein said sealant encapsulates the tissue marker polymer and anchors the tissue marker against migration.
Claim 2
Dependent Claim 36 words
1 . A combination tissue marker polymer and sealant, wherein said tissue marker polymer is formed of a biodegradable polymer and wherein said sealant encapsulates the tissue marker polymer and anchors the tissue marker against migration.
Claim 3
Dependent Claim 41 words
2 . The combination of claim 1 , wherein preselected drugs are admixed with said tissue marker polymer so that said preselected drugs are gradually delivered to a site marked by said tissue marker polymer as said tissue marker polymer biodegrades.
Claim 4
Dependent Claim 41 words
3 . The combination of claim 1 , wherein said tissue marker polymer delivers said preselected drugs to a site marked by said tissue marker polymer at least one month after the site has been marked by said tissue marker polymer.
Claim 5
Dependent Claim 41 words
4 . The combination of claim 1 , wherein said tissue marker polymer delivers said preselected drugs to a site marked by said tissue marker polymer at least six months after the site has been marked by said tissue marker polymer.
Claim 6
Dependent Claim 27 words
5 . The combination of claim 1 , wherein said tissue marker polymer delivers a preselected contrast agent to a site marked by said tissue marker polymer.
Claim 7
Dependent Claim 42 words
6 . The combination of claim 5 , wherein said tissue marker polymer delivers said preselected contrast agent to a site marked by said tissue marker polymer at least one month after the site has been marked by said tissue marker polymer.
Claim 8
Dependent Claim 42 words
7 . The combination of claim 5 , wherein said tissue marker polymer delivers said preselceted contrast agent to a site marked by said tissue marker polymer at least six months after the site has been marked by said tissue marker polymer.
Claim 9
Dependent Claim 18 words
8 . The combination of claim 5 , wherein said preselected contrast agent is an ionic contrast agent.
Claim 10
Dependent Claim 18 words
9 . The combination of claim 5 , wherein said preselected contrast agent is a non-ionic contrast agent.
Claim 11
Dependent Claim 38 words
10 . The combination of claim 1 , wherein said sealant is delivered to a site in dehydrated form and is hydrated by moisture inherent in tissue at said site so that no in situ curing is required.
Claim 12
Dependent Claim 18 words
11 . The combination of claim 1 , wherein said tissue marker polymer is formed of poly (DL-lactide).
Claim 13
Dependent Claim 18 words
12 . The combination of claim 1 , wherein the tissue marker polymer is 75/25 poly (DL-lactide-co-ε-caprolactone) copolymer.
Claim 14
Dependent Claim 20 words
13 . The combination of claim 1 , wherein the tissue marker polymer is a copolymer consisting of 75/25 poly(DL-lactide-co-glycolide).
Claim 15
Dependent Claim 18 words
14 . The combination of claim 13 , wherein said contrast agent is an iohexol solid contrast agent.
Claim 16
Dependent Claim 41 words
15 . A method for anchoring an implant at a specific site, comprising the steps of encapsulating a polymer selected from a group of polymers consisting of poly (dioxanone), polyethylene glycol, hydrogels, polylactides, polyglycolides, polycaprolactone, and their copolymers within a hydrogel.
Claim 17
Dependent Claim 41 words
15 . A method for anchoring an implant at a specific site, comprising the steps of encapsulating a polymer selected from a group of polymers consisting of poly (dioxanone), polyethylene glycol, hydrogels, polylactides, polyglycolides, polycaprolactone, and their copolymers within a hydrogel.
Claim 18
Dependent Claim 24 words
16 . The method of claim 15 , further comprising the step of adding a contrast agent to the polymer selected from said group.
Claim 19
Dependent Claim 24 words
17 . The method of claim 15 , wherein the encapsulation is accomplished by mechanically combining the tissue marker and sealant in a mold.
Claim 20
Dependent Claim 15 words
18 . The method of claim 15 , wherein the encapsulation is accomplished by compression.
Claim 21
Dependent Claim 20 words
19 . The method of claim 15 , wherein the polymer is molded into different shapes to provide anchoring properties.
Claim 22
Dependent Claim 20 words
20 . The method of claim 15 , wherein the polymer is extruded into different shapes to provide anchoring properties.
Claim 23
Dependent Claim 45 words
21 . The method of claim 15 , wherein the hydrogel part of the combined polymer is dehydrated and delivered to said specific site and wherein hydration of the polymer causes its expansion and thus provides a mechanical anchoring of the implant in the tissue.
Claim 24
Dependent Claim 32 words
22 . The method of claim 15 , further comprising the step of adding an anti-cancer drug to the polymer so that said anti-cancer drug is time-released as said polymer is bioabsorbed.
Claim 25
Dependent Claim 30 words
23 . The method of claim 15 , further comprising the step of adding antibiotics to the polymer so that said anti-cancer drug is time-released as said polymer is bioabsorbed.
Claim 26
Dependent Claim 32 words
24 . The method of claim 15 , further comprising the step of adding an anti-inflammatory drug to the polymer so that said anti-cancer drug is time-released as said polymer is bioabsorbed.
Claim 27
Dependent Claim 23 words
25 . The method of claim 15 , wherein said polymer degrades at a rate faster than the degradation rate of said hydrogel.
Claim 28
Dependent Claim 23 words
26 . The method of claim 15 , wherein said polymer degrades at a rate slower than the degradation rate of said hydrogel.
Claim 29
Dependent Claim 23 words
27 . The method of claim 15 , wherein said polymer degrades at the same rate as the degradation rate of said hydrogel.
Claim 30
Dependent Claim 71 words
28 . A method for fabricating tubular implants for implanting in tubular organs, comprising the step of forming a lumen defined by a polymer selected from a group of polymers consisting of poly(dioxanone), polyethylene glycol. hydrogels, polylactides, polyglycolides, polycaprolactone, and their copolymers and a hydrogel that provides the exterior of the implant so that as the hydrogel expands upon contact with a liquid fluid, it anchors itself into the surrounding tissue.
Claim 31
Dependent Claim 71 words
28 . A method for fabricating tubular implants for implanting in tubular organs, comprising the step of forming a lumen defined by a polymer selected from a group of polymers consisting of poly(dioxanone), polyethylene glycol. hydrogels, polylactides, polyglycolides, polycaprolactone, and their copolymers and a hydrogel that provides the exterior of the implant so that as the hydrogel expands upon contact with a liquid fluid, it anchors itself into the surrounding tissue.
Claim 32
Dependent Claim 77 words
29 . The method of claim 28 , wherein the inner layer of the hydrogel contains a circular solid polymer selected from a group of polymers made of poly (dioxanone), polyethylene glycol, hydrogels, polylactides, polyglycolides, polycaprolactone, and their copolymers as a structural support to maintain an open lumen so that the lumen remains open even when the hydrogel has fully expanded because the expansion is radially outward, away from the PGA/PLA/PCL/PDO polymer substrate that defines the lumen.
Claim 33
Dependent Claim 37 words
30 . A method for controlling the degradation rate of a tissue marker polymer, comprising the steps of employing a biodegradable hydrophobic polymer coating to delay the penetration into the substrate by water or other bodily fluid.
Claim 34
Dependent Claim 37 words
30 . A method for controlling the degradation rate of a tissue marker polymer, comprising the steps of employing a biodegradable hydrophobic polymer coating to delay the penetration into the substrate by water or other bodily fluid.
Claim 35
Dependent Claim 20 words
31 . The method of claim 30 , wherein said hydrophobic polymer coating is sprayed onto the tissue marking polymer.
Claim 36
Dependent Claim 20 words
32 . The method of claim 30 , wherein said tissue marking polymer is dipped into the hydrophobic polymer coating.
Claim 37
Dependent Claim 16 words
33 . The method of claim 30 , wherein the hydrophobic polymer coating is polycaprolactone (PCL).
Claim 38
Dependent Claim 58 words
34 . A method for performing a hepatic biopsy, comprising the steps of forming a bore in a liver by a biopsy procedure, providing a plug formed of an expandable sealant material, and sealing said bore at its surface with said plug to prevent bleeding, said plug expanding to securely seal the opening when contacted by bodily moisture.
Claim 39
Dependent Claim 58 words
34 . A method for performing a hepatic biopsy, comprising the steps of forming a bore in a liver by a biopsy procedure, providing a plug formed of an expandable sealant material, and sealing said bore at its surface with said plug to prevent bleeding, said plug expanding to securely seal the opening when contacted by bodily moisture.
Claim 40
Dependent Claim 31 words
35 . The method of claim 34 , further comprising the step of including a marker housed within the expandable sealant material, said markers having utility for viewing and drug delivery.
Claim 41
Dependent Claim 32 words
36 . The method of claim 34 , further comprising the step of including marker particles housed within the expandable sealant material, said marker particles having utility for viewing and drug delivery.
Claim 42
Dependent Claim 45 words
37 . A method for performing an angioplasty procedure, comprising the steps of positioning a non-hydrated hydrogel sealant, in tubular form, within a lumen of an artery, said sealant expanding upon contact with natural body moisture present in said artery to hold the artery open.
Claim 43
Dependent Claim 45 words
37 . A method for performing an angioplasty procedure, comprising the steps of positioning a non-hydrated hydrogel sealant, in tubular form, within a lumen of an artery, said sealant expanding upon contact with natural body moisture present in said artery to hold the artery open.
Claim 44
Dependent Claim 30 words
38 . The method of claim 37 , further comprising the step of positioning a marker material in tubular form, radially inwardly of said hydrogel sealant to provide support therefor.
Claim 45
Dependent Claim 61 words
39 . A method for performing an angioplasty procedure, comprising the steps of providing an expandable sealant material in annular form and positioning a plurality of said annular sealant materials in annular form in longitudinally and equidistantly spaced relation to one another along the extent of an expanded section of artery, in transverse relation to the longitudinal axis of the artery.
Claim 46
Dependent Claim 61 words
39 . A method for performing an angioplasty procedure, comprising the steps of providing an expandable sealant material in annular form and positioning a plurality of said annular sealant materials in annular form in longitudinally and equidistantly spaced relation to one another along the extent of an expanded section of artery, in transverse relation to the longitudinal axis of the artery.
Claim 47
Dependent Claim 36 words
40 . The method of claim 39 , further comprising the step of positioning bioabsorbable marker material in annular form in sandwiched relation between inner and outer layers of said expandable sealant material in annular form.
Claim 48
Dependent Claim 22 words
41 . The method of claim 39 , further comprising the step of including a contrast agent in said bioabsorbable marker material.
Claim 49
Dependent Claim 23 words
42 . The method of claim 39 , further comprising the step of including a preselected therapeutic agent in said bioabsorbable marker material.
Claim 50
Dependent Claim 117 words
43 . A method for treating BHP, comprising the steps of surgically removing a preselected part of a prostate gland that is restricting urine flow through a urethra, positioning within an opening created by said surgical removal a tubular-in-configuration marker that is housed within a tubular-in-configuration sealant, said marker providing support for said sealant and said marker providing a slow delivery of therapeutic agents to the surgical site as said marker is bioabsorbed, said sealant expanding in response to contact by moisture present in said opening, said expansion of said sealant anchoring it to said urethra and to said prostate gland whereby the lumen of said marker performs the function of a urethra until the tissue heals.
Claim 51
Dependent Claim 117 words
43 . A method for treating BHP, comprising the steps of surgically removing a preselected part of a prostate gland that is restricting urine flow through a urethra, positioning within an opening created by said surgical removal a tubular-in-configuration marker that is housed within a tubular-in-configuration sealant, said marker providing support for said sealant and said marker providing a slow delivery of therapeutic agents to the surgical site as said marker is bioabsorbed, said sealant expanding in response to contact by moisture present in said opening, said expansion of said sealant anchoring it to said urethra and to said prostate gland whereby the lumen of said marker performs the function of a urethra until the tissue heals.
Claim 52
Dependent Claim 115 words
44 . A method for delivering pharmaceutical agents to a bladder, comprising the steps of entubing a first tubular section of sealant material within a tubular section of bioabsorbable marker material which is entubed within a second tubular section of sealant material, positioning the structure in dehydrated condition at the neck of the bladder where it joins a urethra, said sealant material expanding in response to contact by moisture to secure the marker in position, whereby drugs for treatment of bladder disease are released from said sealant and administered to the bladder as said sealant is bioabsorbed and whereby said sealant, when hydrated, has enhanced visibility under ultrasound relative to its visibility prior to hydration.
Claim 53
Dependent Claim 115 words
44 . A method for delivering pharmaceutical agents to a bladder, comprising the steps of entubing a first tubular section of sealant material within a tubular section of bioabsorbable marker material which is entubed within a second tubular section of sealant material, positioning the structure in dehydrated condition at the neck of the bladder where it joins a urethra, said sealant material expanding in response to contact by moisture to secure the marker in position, whereby drugs for treatment of bladder disease are released from said sealant and administered to the bladder as said sealant is bioabsorbed and whereby said sealant, when hydrated, has enhanced visibility under ultrasound relative to its visibility prior to hydration.
Claim 54
Dependent Claim 18 words
45 . The method of claim 44 , wherein pharmaceutical agents are carried by said bioabsorbable marker material.
Claim 55
Dependent Claim 80 words
46 . A method for sealing a biliary tract, comprising the steps of sealing said tract with a tubular marker housed within a tubular sealant in a tube-in-tube structure so that an open lumen of the tubular marker enables fluid to flow through the structure and so that the tubular sealant expands in response to contact with moisture to hold the tube-in-tube structure in position, said tubular marker containing a preselected substance for gradual release as the tube-in-tube structure biodegrades.
Claim 56
Dependent Claim 80 words
46 . A method for sealing a biliary tract, comprising the steps of sealing said tract with a tubular marker housed within a tubular sealant in a tube-in-tube structure so that an open lumen of the tubular marker enables fluid to flow through the structure and so that the tubular sealant expands in response to contact with moisture to hold the tube-in-tube structure in position, said tubular marker containing a preselected substance for gradual release as the tube-in-tube structure biodegrades.
Claim 57
Dependent Claim 16 words
47 . The method of claim 46 , wherein said preselected substance is a contrast agent.
Claim 58
Dependent Claim 16 words
48 . The method of claim 46 , wherein said preselected substance is a therapeutic agent.
Claim 59
Dependent Claim 81 words
49 . A method for sealing a fallopian tube, comprising the steps of sealing said fallopian tube with a tubular marker housed within a tubular sealant in a tube-in-tube structure so that an open lumen of the tubular marker enables fluid to flow through the structure and so that the tubular sealant expands in response to contact with moisture to hold the tube-in-tube structure in position, said tubular marker containing a preselected substance for gradual release as the tube-in-tube structure biodegrades.
Claim 60
Dependent Claim 81 words
49 . A method for sealing a fallopian tube, comprising the steps of sealing said fallopian tube with a tubular marker housed within a tubular sealant in a tube-in-tube structure so that an open lumen of the tubular marker enables fluid to flow through the structure and so that the tubular sealant expands in response to contact with moisture to hold the tube-in-tube structure in position, said tubular marker containing a preselected substance for gradual release as the tube-in-tube structure biodegrades.

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