JP5328159B2 - 多波長センサ発光体 - Google Patents
多波長センサ発光体 Download PDFInfo
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- JP5328159B2 JP5328159B2 JP2007558246A JP2007558246A JP5328159B2 JP 5328159 B2 JP5328159 B2 JP 5328159B2 JP 2007558246 A JP2007558246 A JP 2007558246A JP 2007558246 A JP2007558246 A JP 2007558246A JP 5328159 B2 JP5328159 B2 JP 5328159B2
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S439/00—Electrical connectors
- Y10S439/909—Medical use or attached to human body
Description
本願は、米国特許法35 U.S.C.§119(e)に基づき、2005年3月1日に出願された名称「Multiple Wavelength Sensor」の米国仮特許出願第60/657596号、2005年3月1日に出願された名称「Physiological Parameter Confidence Measure」の同第60/657281号、2005年3月1日に出願された名称「Configurable Physiological Measurement System」の同第60/657268号、および2005年3月1日に出願された名称「Noninvasive Multi-Parameter Patient Monitor」の同第60/657759号の優先権の利益を主張する。本願は、以上の開示を参照により本明細書に援用する。
本願は、以下の同時係属中の米国実用特許出願に関連する。
本願では、多くの血液パラメータに言及する。一般的な略称を有する一部の言及対象には、そのような略称を通じて言及する。例えば、本明細書では、HbCOは、一酸化炭素ヘモグロビンを示し、HbMetは、メトヘモグロビンを示し、Hbtは、総ヘモグロビンを示す。また、これらと同じ成分について、当該技術分野では、COHb、MetHb、tHbなど、他の略称も一般的である。これらの成分は、一般にパーセンテージに関して報告され、しばしば、飽和度、相対濃度、または飽和分率(fractional saturation)と呼ばれる。総ヘモグロビンは、一般に濃度g/dLとして報告される。本願で提示される特定の略称の使用は、用語を、指定された成分が記録されるいずれか特定の方式に限定するものではない。
図5は、発光体アレイ700と、基板1200と、等化(equalization)900とを有する発光体アセンブリ500を示す。発光体アレイ700は、電気グリッドの少なくとも1つの行と少なくとも1つの列とにアドレスすることによってそれぞれ作動される、多数の発光源を有する。発光源は、多数の波長を有する光学的放射線を伝達させることができる。等化900は、検出された強度の波長依存性変動を少なくとも低減するために、多数の波長にわたる光学的放射線の組織減衰差を考慮する。基板1200は、発光体アレイおよび発光体に関係した等化のための物理的実装、ならびに発光体アレイと相互接続アセンブリとの間の接続をもたらす。有利には、基板1200は、また、発光源についての動作波長を計算するためにバルク温度測定ももたらす。発光体アレイ700については、以下で図7に関してさらに詳細に説明する。等化については、以下で図9に関してさらに詳細に説明する。基板1200については、以下で図12に関してさらに詳細に説明する。
図7は、多数の波長を有する光702を組織部位1内へと発することができる多数の発光素子(LE)710を有する発光体アレイ700を示す。行ドライバ4530および列ドライバ4560は、発光素子710へと電気的に接続され、電気グリッドの少なくとも1つの行720と少なくとも1つの列740とにアドレスすることによって1つ以上の発光素子710を作動させる。一実施形態では、各発光素子710は、第1の接点712と第2の接点714とを含む。発光素子の第1のサブセット730の第1の接点712は、電気グリッドの第1の導体720と通信している。発光素子の第2のサブセット750の第2の接点714は、第2の導体740と通信している。各サブセットは、少なくとも2つの発光素子を含んでおり、第1のサブセット730および第2のサブセット750の発光素子のうちの少なくとも1つは、共通していない。検出器2400は、発せられた光702を検出し、組織部位1による減衰後の発せられた光702に応答してセンサ信号2500を出力することができる。したがって、センサ信号2500は、前述のように、組織部位1に対応する少なくとも1つの生理学的パラメータを示す。
図9は、コントローラ4500と、発光体アセンブリ500と、検出器アセンブリ2400と、フロントエンド4030とを有する生理学的パラメータ測定システム10を示す。発光体アセンブリ500は、多数の波長を有する光学的放射線を組織部位1内へと伝達させるように構成される。検出器アセンブリ2400は、組織減衰後の光学的放射線に応答してセンサ信号2500を生成するように構成される。フロントエンド4030は、アナログデジタル変換(ADC)の前にセンサ信号2500に条件付けする。
図12は、対応する駆動電流1210に応答して多数の波長を有する光学的放射線1201を伝達させるように構成された発光素子710を示す。発光体についてのバルク温度1202を安定させるために、熱質量1220が発光体710の近くに配置される。温度センサ1230が熱質量1220に熱的に結合されており、その際、駆動電流1210およびバルク温度1202に応じて波長が決定可能となるように、温度センサ1230は、バルク温度1202に応答して温度センサ出力1232を供給する。
λa=f(Tb, I駆動, シグマI駆動) (3)
式中、Tbは、バルク温度であり、I駆動は、後述する、センサコントローラ4500(図45)によって決定される、特定の発光素子についての駆動電流であり、シグマI駆動は、すべての発光素子についての総駆動電流である。他の実施形態では、温度センサは、各発光素子710の温度を測定するように構成されており、各発光素子710の動作波長λaは、式4に従って決定され、
λa=f(Ta, I駆動, シグマI駆動) (4)
式中、Taは、特定の発光素子の温度であり、I駆動は、その発光素子についての駆動電流であり、シグマI駆動は、すべての発光素子についての総駆動電流である。
図19は、発光体アセンブリ500と検出器アセンブリ2400とを実装し、センサケーブル4400に接続し、ケーブルと、発光体アセンブリ500および検出器アセンブリ2400それぞれとの間に電気通信をもたらす、相互接続アセンブリ1900を示す。一実施形態では、相互接続アセンブリ1900は、発光体アセンブリおよび検出器アセンブリを組織部位に対して保持する取付けアセンブリ2700と一体化される。フレキシブル(フレックス)回路を使用する相互接続アセンブリの一実施形態については、以下で図20〜24に関して説明する。
図25は、隣接検出器を有する代替的な検出器アセンブリ2400の一実施形態を示す。発光体700によって発生された多数の波長を有する光学的放射線が、組織部位1内へと伝達される。波長の第1のセットにおける光学的放射線は、例えば、Si検出器など、第1の検出器2510によって検出される。波長の第2のセットにおける光学的放射線は、例えば、GaAs検出器など、第2の検出器2520によって検出される。
図27は、生理学的センサ取付けアセンブリのフィンガークリップの一実施形態2700を示す。フィンガークリップ2700は、フレックス回路アセンブリ1900によって相互接続された発光体アセンブリ500(図6)と検出器アセンブリ2400(図24)とを指先に着脱自在に取り付けるように構成される。フィンガークリップ2700は、発光体シェル3800と、発光体パッド3000と、検出器パッド2800と、検出器シェル3900とを有する。発光体シェル3800と検出器シェル3900とは、ばねアセンブリ3500によって回転自在に連結され、併せて付勢される。発光体パッド3000は、発光体シェルによって固定保持される。発光体アセンブリ500(図6)は、発光体パッド3000の近くに実装され、複数の波長を有する光学的放射線を指先組織内へと伝達させるように適合される。検出器パッド2800は、検出器シェル3900によって固定保持される。検出器アセンブリ2400は、検出器パッド2800の近くに実装され、指先組織による減衰後の光学的放射線を受け取るように適合される。
図40は、以上で図1〜3に関して概説した、モニタ100と対応するセンサアセンブリ200とを示す。センサアセンブリ200は、センサ400とセンサケーブル4400とを有する。センサ400は、センサコントローラ4500内のドライバに応答して光学的放射線を組織部位内へと伝達させる発光体を有する発光体アセンブリ500を内蔵する。センサ400は、また、組織減衰後の光学的放射線に応答してセンサ信号2500を供給する検出器アセンブリ2400も内蔵する。センサ信号2500は、フロントエンド4030によってフィルタリングされ、増幅され、サンプリングされ、デジタル化され、やはりセンサコントローラ4500にコマンドを出すDSP(デジタルシグナルプロセッサ: digital signal processor)4040に入力される。センサケーブル4400は、駆動信号をセンサコントローラ4500から発光体アセンブリ500へと電気的に通信し、またセンサ信号2500を検出器アセンブリ2400からフロントエンド4030へと電気的に通信する。センサケーブル4400は、モニタセンサポート110にプラグ接続するモニタコネクタ210を有する。
図41〜43は、代替的なセンサの諸実施形態を示す。電気グリッド内に配置された発光体アレイ700(図7)を作動させるように構成されたセンサコントローラ4500については、上述した図7に関して記載されている。有利には、そのように構成されたセンサコントローラ4500は、また、逆接続LED 4110、4120もしくは情報要素4300またはその両方を有する、従来の2波長(赤色およびIR)センサ4100を駆動することができる。
図42〜43は、電気グリッド内に接続された発光素子を作動させるように構成された発光体アレイドライバと通信する、情報要素4200〜4300の諸実施形態を示す。情報要素は、対応するDC、AC、またはDCとACとの組合せの電気グリッド駆動信号に応答して、DC値、AC値、またはDC値とAC値との組合せとして情報を提供するように構成される。図42は、行710と列720とを有する電気グリッドによって有利には直接的に駆動される情報要素の実施形態4200を示す。具体的には、情報要素4200は、電気グリッドの行ライン710と列ライン720との間に接続された、直列接続された抵抗R2 4210とダイオード4220とを有する。この方法では、抵抗R2値を、LED 810(図8)が作動されるのと類似の方法で読み取ることができる。ダイオード4220は、寄生電流がLED 810(図8)を不要に作動させるのを防ぐために、例えば、LEDとしてアノードが行にカソードが列にくる向きに配置される。
図44A〜Bは、外側ジャケット4410と、外側シールド4420と、多数の外側ワイヤ4430と、内側ジャケット4440と、内側シールド4450と、導電性ポリマー4460と、内側撚線対4470とを有するセンサケーブル4400を示す。外側ワイヤ4430は、有利には、多数の駆動信号を発光体アレイ700(図7)へとコンパクトに運ぶように構成される。一実施形態では、4つのアノード駆動信号4501(図45)と、4つのカソード駆動信号4502(図45)と、2つのサーミスタピンアウト1450(図15)と、2つのスペアとに対応する、12本の外側ワイヤ4430が存在する。内側撚線対4470は、センサ信号2500(図25)に対応し、摩擦電気ノイズを低減するために導電性ポリマー4460内に押し出される。シールド4420、4450および撚線対4470は、センサ信号2500(図25)のEMIおよびクロストーク耐性を高める。
図45は、モニタ100(図1)内に配置され、アノード駆動信号4501およびカソード駆動信号4502を発光体アレイ700(図7)に供給するように構成されたセンサコントローラ4500を示す。モニタのための信号処理機能を実行するDSP(デジタルシグナルプロセッサ)4040は、また、センサコントローラ4500にコマンド4042を与える。これらのコマンドは、駆動信号4501、4502のレベルおよびタイミングを決定する。センサコントローラ4500は、コマンドレジスタ4510と、アノードセレクタ4520と、アノードドライバ4530と、電流DAC(デジタルアナログ変換器)4540と、電流マルチプレクサ4550と、カソードドライバ4560と、電流計4570と、電流制限器4580とを有する。コマンドレジスタ4510は、DSPコマンド4042に応答して制御信号を供給する。一実施形態では、コマンドレジスタ4510は、DSP 4040からシリアルコマンドデータ4042をロードして、センサコントローラ4500内の様々な機能を選択もしくはイネーブルにする出力ビットを同期的にセットするシフトレジスタであり、これについては後述する。
図46に示されるように、センサ400は、発光体シェル3800と、発光体パッド3000と、フレックス回路アセンブリ2200と、検出器パッド3100と、検出器シェル3900とを有する。センサケーブル4400は、フレックス回路2100と、発光体アセンブリ500と、検出器アセンブリ2400とを含むフレックス回路アセンブリ2200に取り付けられる。センサケーブル4400取付部と発光体アセンブリ500とを有するフレックス回路アセンブリ2200の部分は、発光体シェル3800および発光体パッド3000によって収容される。検出器アセンブリ2400を有するフレックス回路アセンブリ2200の部分は、検出器シェル3900および検出器パッド3100によって収容される。具体的には、検出器アセンブリ2400は、シュー3200に挿入され、シュー3200は、検出器パッド3100に挿入される。発光体シェル3800と検出器シェル3900とは、ばね3600のコイル部に挿通されるヒンジピン410によって締着され、該ヒンジピン410の周りで回動する。ばね3600は、ばねプレート3700によって検出器シェル3900に対して保持される。指止め450が検出器シェルに取り付けられる。一実施形態では、シリコーン接着剤420を使用してパッド3000、3100をシェル3800、3900に取り付け、シリコーンポッティング化合物430を使用して発光体アセンブリ500および検出器アセンブリ2400をパッド3000、3100内にしっかり固定し、シアノアクリル接着剤440がセンサケーブル4400を発光体シェル3800へとしっかり固定する。
10 生理学的測定システム、生理学的パラメータ測定システム
100 モニタ
110 モニタセンサポート
160 モニタキー
170 ディスプレイ
200 多波長センサアセンブリ
210 モニタコネクタ
400 センサ、センサアセンブリ
401 センサ
402 センサ
410 ヒンジピン
420 シリコーン接着剤
430 シリコーンポッティング化合物
440 シアノアクリル接着剤
450 指止め
500 発光体アセンブリ
600 密封材、透明媒体
700 発光体アレイ
702 光
710 発光ダイオード、発光素子、LE、行、行ライン
712 第1の接点
714 第2の接点
720 行、第1の導体、列、列ライン
730 第1のサブセット
740 列、第2の導体
750 第2のサブセット
801 LED
810 行
812 アノード駆動ライン
820 列
822 カソード駆動ライン
900 等化
910 HbおよびHbO2による組織の光吸収、減衰曲線
1100 光学フィルタ、フィルタリング媒体
1200 基板
1201 光学的放射線
1202 バルク温度
1210 駆動電流
1220 熱質量
1230 温度センサ
1232 温度センサ出力
1301 コンポーネント側部
1302 はんだ側部
1305 コンポーネント端部
1306 コネクタ端部
1310 位置合わせノッチ
1401 コンポーネント層
1402、1403、1404、1405 内層
1406 はんだ層
1411 金属化領域
1510 コンポーネントパッド
1520 ワイヤボンドパッド
1530 コネクタ
1532、1534 コネクタパッド
1540 サーミスタ
1550 サーミスタパッド
1900 相互接続アセンブリ、フレックス回路アセンブリ、フレキシブル回路アセンブリ
2040、2050 導体
2060 デカップリング
2070 シールド
2100 フレックス回路
2200 フレックス回路、回路基板、センサフレックス回路
2201 発光体端部
2202 検出器端部
2204 相互接続部、首部
2206 相互接続部、尾部
2210 発光体実装部、発光体はんだパッド
2214 据付耳部
2220 検出器実装部
2230 ケーブルコネクタ、翼部
2232 はんだパッド領域
2236 検出器ワイヤパッド
2238 外側ワイヤパッド
2240 折り返し伝導性インクフラップ(fold-over conductive ink flap)
2330 リフローはんだ
2400 検出器アセンブリ、検出器
2410 検出器
2420 はんだパッド
2430 銅メッシュテープ
2440 EMIシールド
2442 EMIシールドタブ
2444 EMIシールドグリッド
2450 フォイル
2452 孔部
2460 素子
2500 センサ信号
2510、2520、2610、2620 検出器
2700 取付けアセンブリ、フィンガークリップ
2800 検出器パッド
2801 第1の端部
2802 第2の端部
2803 パッド表面
2810 ガイド
2820 輪郭部
2830 止め部
2840 検出器孔部
3000 発光体パッド、センサパッド
3010 発光体パッドフラップ
3020 発光体窓
3030 据付ピン
3040 発光体アセンブリキャビティ
3050 分離ノッチ
3060 シェル取付部
3070 フレックス回路ノッチ
3080 ケーブルノッチ
3100 検出器パッド、センサパッド
3110 検出器パッドフラップ
3120 シューボックスキャビティ
3150 分離ノッチ
3160 取付点
3200 シューボックス、シュー
3210 検出器窓
3220 フレックス回路ノッチ
3300 細い指用の発光体パッド
3400 細い指用の検出器パッド
3500 ばねアセンブリ
3600 ばね
3610 コイル部
3620 発光体シェル用脚部
3630 検出器シェル用脚部
3700 ばねプレート
3710 取付孔
3720 ばね脚部スロット
3730 シェルフ
3800 発光体シェル
3810 ヒンジ
3812 ヒンジ孔部
3820 把持部
3900 検出器シェル
3910 ヒンジ
3912 ヒンジ孔部
3920 把持部
3930 シェルポスト
4000 情報要素
4020 読取装置
4030 フロントエンド
4040 DSP、デジタルシグナルプロセッサ
4042 コマンド
4100 センサ
4110 LED
4120 LED
4130 電気グリッド
4132 第1の行導体、第1の行入力、第1の行信号
4134 第1の列導体、第1の列入力、第1の列信号
4136 第2の行導体、第2の行入力、第2の行信号
4138 第2の列導体、第2の列入力、第2の列信号
4152 第1の接点、第1の出力、第1の出力信号
4154 第2の接点、第2の出力、第2の出力信号
4200 情報要素
4210 抵抗
4220 ダイオード
4300 情報要素
4400 センサケーブル
4410 外側ジャケット
4420 外側シールド
4430 外側ワイヤ
4440 内側ジャケット
4450 ケーブル内側シールド
4460 導電性ポリマー
4470 検出器ワイヤ、内側撚線対
4500 センサコントローラ
4501 行駆動ライン、アノード駆動信号
4502 列駆動ライン、カソード駆動信号
4510 コマンドレジスタ
4512 上限値
4514 トリップリセット
4516 アノードセレクト
4518 カソードオン
4519 コマンドレジスタデータ
4520 アノードセレクタ
4522 アノードオン
4530 行ドライバ、アノードドライバ
4540 電流DAC
4542 DAC出力
4550 電流マルチプレクサ
4552 電流セット
4560 列ドライバ、カソードドライバ
4570 電流計
4572 電流測定値
4580 電流制限器
4582 イネーブル
Claims (20)
- 複数の生理学的パラメータを測定する生理学的センサであって、
複数の発光源を含んでおり、前記発光源それぞれが、電気グリッドの複数の行の少なくとも1つと複数の列の少なくとも1つとにアドレスすることによって作動され、前記発光源が複数の波長の光を組織部位内へと伝達させることができ、前記行および列の交点よりも少ない発光源があり、前記生理学的センサがさらに、
身体組織による減衰後の透過光に応答する検出器を含み、
所定の範囲の波長を有する前記発光源は、同一の行にグループ化される生理学的センサ。 - 前記発光源のうちの多数のものが、同一波長の光を伝達させることができ、前記多数のものが、前記行の1つにアドレスすることによって同時に作動される、請求項1に記載の生理学的センサ。
- 前記発光源がLEDであり、
前記行の1つと前記列の1つとを駆動すると前記LEDのうち唯1つが作動されるように、前記LEDそれぞれが、前記行の1つと共通するアノードと、前記列の1つと共通するカソードとを有する、請求項2に記載の生理学的センサ。 - 前記複数の行と導通する複数の行ドライバと、
前記複数の列と導通する複数の列ドライバとをさらに含んでおり、
前記LEDのうちアドレスされたものを作動させるために、選択された行ドライバが、対応する行に電流をソースし、選択された列ドライバが、対応する列から電流をシンクする、請求項3に記載の生理学的センサ。 - 前記LEDのうちアドレスされていないものからの寄生電流を実質的に阻止するために、前記行ドライバのうち選択解除されたものが、対応する行を低電圧にプルダウンし、前記列ドライバのうち選択解除されたものが、対応する列を高電圧にプルアップする、請求項4に記載の生理学的センサ。
- 前記電気グリッドが少なくとも3つの行または少なくとも3つの列を含む、請求項5に記載の生理学的センサ。
- 前記電気グリッドが少なくとも8つのLEDと導通する、請求項5に記載の生理学的センサ。
- 前記電気グリッドが、最高16個までのLEDと導通する4つの行および4つの列を含む、請求項5に記載の生理学的センサ。
- 複数の生理学的パラメータを測定する生理学的センサであって、
電気グリッドの複数の行導体および複数の列導体を含んでおり、
それぞれ第1の接点と第2の接点とを含む、複数の波長の光を組織部位内へと伝達させることができる複数の発光源を含んでおり、前記複数の発光源の各々の前記第1の接点が、前記複数の行導体の少なくとも1つと導通しており、前記複数の発光源の各々の前記第2の接点が、前記複数の列導体の少なくとも1つと導通しており、前記行導体および列導体の交点よりも少ない発光源があり、前記生理学的センサがさらに、
身体組織によって減衰された透過光を検出して、前記身体組織の少なくとも1つの生理学的パラメータを示す信号を出力することができる検出器を含み、
所定の範囲の波長を有する前記発光源は、同一の行にグループ化される生理学的センサ。 - 前記複数の行導体の1つと前記複数の列導体の1つとを駆動して、前記発光源の1つを作動させる、請求項9に記載の生理学的センサ。
- 前記電気グリッドが4つの行導体と4つの列導体とを含んでおり、
前記発光源が最高16個までのLEDを含む、請求項10に記載の生理学的センサ。 - 前記発光源の2つ以上が、同一波長を有する光を伝達させることができ、また、同時に作動させることができる、請求項10に記載の生理学的センサ。
- 前記発光源がLEDであり、
前記LEDの前記第1の接点がアノード接点であり、
前記LEDの前記第2の接点がカソード接点である、請求項9に記載の生理学的センサ。 - 前記第1の行導体と導通する第1のプッシュプルドライバと、
前記第1の列導体と導通する第2のプッシュプルドライバとをさらに含んでおり、
前記LEDの1つを作動させるために、前記第1のプッシュプルドライバが前記アノード接点に電流をソースするように適合され、前記第2のプッシュプルドライバが前記カソード接点から電流をシンクするように適合され、
動作停止されたLEDを逆バイアスするために、前記第1のプッシュプルドライバが電流をシンクするように適合され、前記第2のプッシュプルドライバが電流をソースするように適合される、請求項13に記載の生理学的センサ。 - 複数の生理学的パラメータを測定する生理学的センサ方法であって、
身体組織に対してセンサを位置決めする段階であって、前記センサは、前記身体組織上に光を与えるように配置された複数の発光源と、検出器とを含み、前記複数の発光源は、
行および列を含む電気グリッドに配置され、前記行および列の交点よりも少ない発光源がある、段階と、
前記複数の発光源の各々を作動させる段階であって、各発光源を作動させる前記段階は、複数の波長を有する光を発するために、前記電気グリッドの前記行の少なくとも1つおよび前記列の少なくとも1つを順次アドレスする段階を含む、段階と、
発せられた光を身体組織による減衰後に検出する段階と、
前記検出された発せられた光に基づき、複数の生理学的特徴を示す反射する信号を生成する段階と
を含み、
所定の範囲の波長を有する前記発光源は、同一の行にグループ化される方法。 - 前記電気グリッドの唯1つの接合部のところで前記発光源を1つずつ接続する段階をさらに含む、請求項15に記載の方法。
- 第1の行にアドレスする段階と、
第1の列にアドレスする段階とをさらに含んでおり、
前記アドレスされた第1の行と前記アドレスされた第1の列との間に接続された発光源が作動される、請求項16に記載の方法。 - 前記発光源のうち作動されたものをプッシュ/プル駆動する段階をさらに含む、請求項17に記載の方法。
- 前記発光源のうち動作停止されたものを逆バイアスする段階をさらに含む、請求項18に記載の方法。
- 前記発光源のうち同一波長のものを複数提供する段階と、
前記同一波長の発光源に同時にアドレスする段階とをさらに含む、請求項19に記載の方法。
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