JP6326124B2 - 薬剤送達のための注入用装置 - Google Patents
薬剤送達のための注入用装置 Download PDFInfo
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- JP6326124B2 JP6326124B2 JP2016244154A JP2016244154A JP6326124B2 JP 6326124 B2 JP6326124 B2 JP 6326124B2 JP 2016244154 A JP2016244154 A JP 2016244154A JP 2016244154 A JP2016244154 A JP 2016244154A JP 6326124 B2 JP6326124 B2 JP 6326124B2
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- 238000007725 thermal activation Methods 0.000 description 1
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- 229960000874 thyrotropin Drugs 0.000 description 1
- 230000001748 thyrotropin Effects 0.000 description 1
- 229960004605 timolol Drugs 0.000 description 1
- 229960005221 timolol maleate Drugs 0.000 description 1
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- 229960005267 tositumomab Drugs 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 229960002368 travoprost Drugs 0.000 description 1
- MKPLKVHSHYCHOC-AHTXBMBWSA-N travoprost Chemical compound CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(C(F)(F)F)=C1 MKPLKVHSHYCHOC-AHTXBMBWSA-N 0.000 description 1
- VSQQQLOSPVPRAZ-RRKCRQDMSA-N trifluridine Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(C(F)(F)F)=C1 VSQQQLOSPVPRAZ-RRKCRQDMSA-N 0.000 description 1
- 229960003962 trifluridine Drugs 0.000 description 1
- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 description 1
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- UHTHHESEBZOYNR-UHFFFAOYSA-N vandetanib Chemical compound COC1=CC(C(/N=CN2)=N/C=3C(=CC(Br)=CC=3)F)=C2C=C1OCC1CCN(C)CC1 UHTHHESEBZOYNR-UHFFFAOYSA-N 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
- 230000004304 visual acuity Effects 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- JLQFVGYYVXALAG-CFEVTAHFSA-N yasmin 28 Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1.C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 JLQFVGYYVXALAG-CFEVTAHFSA-N 0.000 description 1
- CGTADGCBEXYWNE-JUKNQOCSSA-N zotarolimus Chemical compound N1([C@H]2CC[C@@H](C[C@@H](C)[C@H]3OC(=O)[C@@H]4CCCCN4C(=O)C(=O)[C@@]4(O)[C@H](C)CC[C@H](O4)C[C@@H](/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C3)OC)C[C@H]2OC)C=NN=N1 CGTADGCBEXYWNE-JUKNQOCSSA-N 0.000 description 1
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Classifications
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
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Description
本国際特許出願は、2010年8月5日に出願された米国特許出願第61/371154号、名称「薬剤送達のための注入用装置および方法」(代理人整理番号93161−790300(004400US));2011年6月20日に出願された米国特許出願第61/499,095号、名称「薬剤送達のための注入用装置および方法」(代理人整理番号93161−809222(004410US));2011年6月24日に出願された米国特許出願第61/501,021号、名称「薬剤送達のための注入用装置および方法」(代理人整理番号93161−810847(004420US));2011年7月1日に出願された米国特許出願第61/504,038号、名称「薬剤送達のための注入用装置および方法」(代理人整理番号93161−813922(004430US));2010年8月5日に出願された第61/371169号、名称「埋め込み型治療デバイス」、(代理人整理番号93161−790659(004600US));2011年6月9日に出願された米国特許出願第61/495,251号、名称「診断方法および装置」(代理人整理番号93161−808320(000100US));および2011年6月10日に出願された米国特許出願第61/495,718号、名称「診断方法および装置」(代理人整理番号93161−808370(00011OUS))に基づく優先権を主張し、その全開示を参照によりここに援用するものである。
該当無し
(a)免疫グロブリンG 150キロダルトン 10.5nm
(b)ウシ血清アルブミン 69キロダルトン 7.2nm
(c)免疫グロブリンGのFabフラグメント 49キロダルトン 流体力学的直径の報告なし
放出速度=(DP/F)A(cR−cV)/L
但し、
cR=リザーバ内の濃度
cV=リザーバ外、すなわち硝子体内の濃度
D=リザーバ溶液中の治療薬の拡散係数
P=多孔質構造体の多孔率
F=多孔質構造体のチャネルの蛇行パラメータに対応し得るチャネル・パラメータ
A=多孔質構造体の面積
L=多孔質構造体の厚さ(長さ)
累積放出率=1−cR/cR0=1−exp((−DPA/FLVR)t)
但し、t=時間、Vr=リザーバ容積
DTA,37C=DBSA,20C=(η20C/η37C)(MWBSA/MWTA)1/3
但し、MWは、BSAまたはテスト化合物の分子量を表し、ηは水の粘度である。以下に、対象となるタンパク質の拡散係数の一覧を示す。
cR=cR0exp((−D PA/FL VR)t)
累積放出=1−cR/cR0
cV=デバイスからの放出速度/kVV
速度=Vr(dCr/dt)=−D(PA/TL)Cr
但し、速度=デバイスからの治療薬放出速度
Cr=リザーバ中の治療薬濃度
Vr=リザーバ容積
D=拡散定数
PA/TL=RRI
P=多孔率
A=面積
T=蛇行率=F=チャネル・パラメータ
実質的に一定の容積での注入の場合
Cr0=(注入容積)(製剤濃度)/Vr
但し、Cr0=製剤の注入後のリザーバ中の初期濃度
注入容積=50μLの場合
Cr0=(0.05mL)(10mg/mL)/Vr(1000μg/1mg)=500μg/Vr
速度=x(500μg)exp(−xt)
但し、t=時間
x=(D/Vr)(PA/TL)
硝子体での質量バランスを考慮して
Vv(dCv/dt)=デバイスからの速度=kVvCv
但し、Vv=硝子体容積(約4.5mL)
Cv=硝子体中の治療薬濃度
k=硝子体からの薬の速度(硝子体中の薬の半減期の逆数に比例)
ここに記載される実施態様に適切な場合、すなわちCvが実質的に一定のままであり時間とともにゆっくりと変化する(すなわち、dCv/dtが約0)場合、
Cv=(デバイスからの速度)/(kVv)
kVvが実質的に一定であるので、Cvの最大値は、デバイスからの速度を最大にする条件に対応するであろう。デバイスへの注入後任意の時間(例えば180日)に、最大速度を与えるxの値で最大Cv値が得られる。xの最適値は、任意の時間で、
d(速度)/dx=0を満たす。
速度=500(x)exp(−xt)=f(x)g(x)
但し、f(x)=500x,g(x)=exp(−xt)
d(速度)/dx=f’(x)g(x)+f(x)g’(x)=500(1−xt)exp(−xt)
任意の時間tに対して,1−xt=0すなわちxt=1のとき、d(速度)/dx=0となる。
速度は、(D/Vr)(PA/TL)t=1のとき最大となる。
任意の容積では、最適PA/TL=最適RRI=Vr/(Dt)
従って、任意の時間tでの最大Cvは、任意のVrで最適RRI=(PA/FL)のとき与えられる。
また、(Vr)/(RRI)比=(Vr)/(PA/TL)=Dtにより、その時の最適速度が決定されることになる。
表X
Claims (16)
- 治療剤を、少なくとも部分的に眼に埋め込まれている眼用インプラントのリザーバチャンバへと注入するためのデバイスであって、該デバイスは:
− 該眼用インプラントの該リザーバチャンバへと延伸するように構成されている、針
ここで該針は、
・ 治療剤を、該リザーバチャンバへと注入するための経路を提供するように構成された、内部注入管腔、および
・ 該リザーバチャンバ内の埋め込み流体が、眼用インプラントを出る経路を提供するように構成された、出口管腔
を画定する、
− 該出口管腔を経由して該眼用インプラントを出る該埋め込み流体を、該受容チャンバが受容するように、該出口管腔に流体連結された、受容チャンバ、および
− 該受容チャンバに流体連結する、ならびに、気体に対する第1の流れ抵抗および該埋め込み流体に対する第2の流れ抵抗を有する、第1の多孔質構造体
を含み、
ここで、該内部注入管腔への陽圧の印加により、同時に、ある量の治療剤を、該内部注入管腔を経由して眼用インプラントへと注入し、および、ある量の埋め込み流体を、該出口管腔を介して、該受容チャンバへと置き換え、ならびに、該ある量の埋め込み流体の置き換えがいったん起こると、該埋め込み流体は該第1の多孔質構造体に接触して、該第2の流れ抵抗が該埋め込み流体に作用して、該埋め込み流体が該第1の多孔質構造体を通過するのを防ぐ、
前記デバイス。 - 出口管腔と内部注入管腔とが、互いに対して同心円状に位置されている、請求項1に記載のデバイス。
- 内部注入管腔へと、除去可能に取り付けられるように構成されている、ソースチャンバをさらに含む、請求項1または2に記載のデバイス。
- 内部注入管腔を介して眼用インプラントへと注入するための治療剤で、ソースチャンバが充填されている、請求項3に記載のデバイス。
- ソースチャンバが、内部注入管腔へと取り付けられるシリンジの一部分である、請求項3または4に記載のデバイス。
- 内部注入管腔へと流体連結するように構成されたシリンジを除去可能に受容するように構成されたコネクタをさらに含む、請求項1〜5のいずれか一項に記載のデバイス。
- 内部注入管腔の、眼用インプラントへの挿入深さを限定するように構成された、ストッパーをさらに含む、請求項1〜6のいずれか一項に記載のデバイス。
- 出口管腔が内部注入管腔を、該内部注入管腔の少なくとも一部分の長さの周りで包囲する、請求項1〜7のいずれか一項に記載のデバイス。
- 眼用インプラントから置き換えられた該量の埋め込み流体を、分析のために貯蔵するように、受容チャンバが構成された、請求項1〜8のいずれか一項に記載のデバイス。
- 該量の埋め込み流体が、眼の硝子体液の成分、および、眼用インプラント内で前に置き換えられた残りの量の治療剤を含む、請求項1〜9のいずれか一項に記載のデバイス。
- 該量の治療剤が、該量の埋め込み流体と混合されるのを阻害する流速で治療剤を注入するように構成されている、請求項1〜10のいずれか一項に記載のデバイス。
- 請求項1〜11のいずれか一項に記載のデバイスであって、内部注入管腔が該内部注入管腔からの第1の開口部を有し、および出口管腔が該出口管腔への第2の開口部を有し、ここで該内部注入管腔は該出口管腔よりも長く、そのため該内部注入管腔からの該第1の開口部は、該出口管腔への該第2の開口部に対して遠位に位置している、前記デバイス。
- 眼用インプラントおよび請求項1〜12のいずれか一項に記載のデバイスを含むシステムであって、眼用インプラントが、治療剤を該眼用インプラントから放出させるように構成された第2の多孔質構造体を含み、該第2の多孔質構造体は第3の流れ抵抗を有する、前記システム。
- 請求項13に記載のシステムであって、第1の多孔質構造体の第2の流れ抵抗は、チャネル内の埋め込み流体が該第1の多孔質構造体と接触するときに、第2の多孔質構造体の第3の流れ抵抗に比例するか、または該第2の多孔質構造体の該第3の流れ抵抗よりも大きく、それにより、治療剤が内部注入管腔をとおって該眼用インプラントへと注入されて、眼用インプラント内の第2の量の埋め込み流体が該第2の多孔質構造体をとおって眼用インプラントを出て、埋め込み流体の、眼へのボーラス投与を提供する、前記システム。
- 第2の流れ抵抗が第3の流れ抵抗よりも小さく、該量の埋め込み流体の量を、注入された該量の治療剤の量と少なくとも分離する、請求項13に記載のシステム。
- リザーバチャンバが、狭小プロフィール構成から拡張プロフィール構成へと、眼内で拡張可能である、請求項13〜15のいずれか一項に記載のシステム。
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