Oximetry probe with electronically selectable tissue depth analysis
43 claims: 4 independent, 39 dependent
- 1オキシメータ装置用のプローブカバーであって、前記プローブカバーの第1の部分を含み、前記第1の部分は第1の開放端と前記第1の開放端と反対側の第1の封閉端とを含み、前記第1の封閉端は表示パネルを含み、前記プローブカバーはさらに、前記プローブカバーの第2の部分を含み、前記第2の部分は第2の開放端と前記第2の開放端と反対側の第2の封閉端とを含み、前記第2の封閉端は光センサパネルを含み、前記第2の開放端への前記第1の開放端の連結がオキシメータ装置のための封止されたプローブカバー封包物を構成し、前記光センサパネルは透明であり、 2 50μm未満の厚さを有し、前記封止されたプローブカバー封包物において、前記オキシメータ装置の表示が前記プローブカバーの前記表示パネルを通して視認されるとき、前記オキシメータ装置のプローブ先端によって出射された光が前記プローブカバーの前記光センサパネルを通して出射され、前記オキシメータ装置で受光された光が前記プローブカバーの前記光センサパネルを通して出射され、前記封止されたプローブカバー封包物は、前記封包物の外側からの汚染物質が前記封包物の内側に含まれる前記オキシメータ装置に接触することを防止し、前記プローブカバーの前記第2の部分は前記第2の封閉端に防護壁を含み、前記防護壁は前記光センサパネルに連結され、前記防護壁は測定される組織上の汚染物質が前記封包物の内部に含まれる前記オキシメータ装置に接触することを防止する、プローブカバー。
- 2前記光センサパネルは、オキシメータの測定に減衰影響を与えず、 6 50nm~ 9 00nmの波長範囲の光を透過させる、請求項1に記載のプローブカバー。
- 3前記光センサパネルは、 1 50μm未満の厚さを含む、請求項1に記載のプローブカバー。
- 4前記光センサパネルは、 1 00μm未満の厚さを含む、請求項1に記載のプローブカバー。
- 5前記光センサパネルは、 5 0μm未満の厚さを含む、請求項1に記載のプローブカバー。
- 6前記光センサパネルの厚さは、均一である、請求項1に記載のプローブカバー。
- 7前記光センサパネルの第1面は前記オキシメータ装置のプローブ先端のセンサの表面と一致し、前記第1面は前記プローブ先端の前記センサと隙間なく同一平面となるように構成される、請求項1に記載のプローブカバー。
- 8前記プローブカバーは、ポリカーボネートを含む、請求項1に記載のプローブカバー。
- 9前記プローブカバーは、剛性ポリマーを含む、請求項1に記載のプローブカバー。
- 10前記光センサパネルは、ポリカーボネートを含む、請求項1に記載のプローブカバー。
- 11前記プローブカバーの前記第2の部分は、剛性ポリマーを含み、前記光センサパネルは、前記剛性ポリマーに比べて可撓性ポリマーを含む、請求項1に記載のプローブカバー。
- 12前記プローブカバーの前記第2の部分は、可撓性ポリマーを含み、前記光センサパネルは、前記可撓性ポリマーに比べて剛性ポリマーを含む、請求項1に記載のプローブカバー。
- 13キットであって、オキシメータプローブを含み、前記オキシメータプローブは、本体部を含み、前記本体部は、第1側面および第2側面によって連結された前方側面および後方側面を含む矩形の管状部と、先端部とを含み、前記先端部は、前記前方側面に連結された第1指載置面を含み、前記第1指載置面は、前記前方側面に対して第1転回方向に沿って第1角度で延在する凸面であり、前記第1指載置面に連結された前方先端面を含み、前記前方先端面は、前記第1指載置面に対して第2転回方向に沿って第2角度で延在し、前記前方先端面に連結された底面を含み、前記底面は、前記第1指載置面に対して前記第2転回方向に沿って第3角度で延在し、前記底面は、前記装置のセンサヘッドを保持するための開口を含み、前記後方側面に連結された第2指載置面を含み、前記第2指載置面は、前記後方側面に対して前記第1転回方向に沿って第4角度で延在する凹面であり、前記第2指載置面と前記底面との間に連結された後方先端面を含み、前記後方先端面は、前記第2指載置面に対して前記第1転回方向に沿って第5の角度で延在する凸面であり、前記キットは、前記オキシメータプローブの1つ以上の部分の形状と一致するプローブカバーを含み、前記プローブカバーは、前記オキシメータ装置のプローブ先端を前記プローブカバー内に挿入するための開放端を含み、前記プローブ先端は、光センサを含み、前記プローブ先端は、前記プローブカバーに完全に挿入され、光インターフェイス部を含み、前記光インターフェイス部は、プローブ先端を前記プローブカバーに挿入したときに、前記オキシメータ装置の前記光センサまたは前記プローブ先端に対して位置決めされるように配置され、前記光インターフェイス部に連結された防護壁を含み、前記防護壁は、前記オキシメータ装置によって測定される組織上の汚染物質が前記プローブ先端に接触することを防止すると共に、前記光センサによって出射された光エネルギーが前記プローブカバーの前記光インターフェイス部を通って前記組織に入り、前記組織によって反射された光エネルギーが前記プローブカバーの前記光インターフェイス部を通って前記光センサに入ることを可能にするものであり、前記光インターフェイス部は、 2 50μm未満の厚さを有する、キット。
- 14前記光インターフェイス部の第1屈折率と前記光センサの第2屈折率との差は、50%未満である、請求項13に記載のキット。
- 15前記光インターフェイス部は、第1面と第2面との間に設けられ、前記第1面は、前記光センサに対して位置決めされるように配置され、前記第2面は、前記組織に対して位置決めされるように配置され、前記第1面と前記第2面とは、互いに平行である、請求項13に記載のキット。
- 16方法であって、スリーブを形成するステップを含み、前記スリーブを形成するステップは、前記オキシメータ装置のプローブ先端を前記プローブカバーに挿入可能な前記スリーブの開放端を形成するステップを含み、前記プローブ先端は、光センサを含み、前記光センサはセンサ材料を含み、第1の剛性を有する光インターフェイス材料を含む光インターフェイス部を形成するステップを含み、前記光インターフェイス部は、前記光インターフェイス材料の円盤形状を含むとともに、前記プローブ先端を前記プローブカバーに挿入したときに、前記オキシメータ装置の前記光センサまたは前記プローブ先端に対して位置決めされるように配置され、前記光インターフェイス部に連結された防護壁を形成するステップを含み、前記防護壁は前記第1の剛性よりも小さい第2の剛性を有する防護壁材料を含み、前記防護壁は前記オキシメータ装置によって測定される組織上の汚染物質が前記プローブ先端に接触することを防止すると共に、前記光センサによって出射された光エネルギーが前記プローブの前記光インターフェイス部を通って前記組織に入り、前記組織によって反射された光エネルギーが前記プローブカバーの光インターフェイス部を通って前記光センサに入ることを可能にするものであり、 2 50μm未満の厚さを有する前記光インターフェイス部を形成するステップと、前記光インターフェイス部の前記第2の材料の第1屈折率と前記光センサの前記第2の材料の第2屈折率との差を50%未満にするステップと、第1面と第2面との間に前記光インターフェイス部を形成するステップとを含み、前記第1面は、前記光センサに対して位置決めされるように配置されるように構成され、前記第2面は、前記組織に対して位置決めされるように配置されるように構成され、前記第1面と前記第2面とを互いに平行であるように形成するステップを含む、方法。
- 17実質的に減衰することなく、 6 50nm~ 9 00nmの波長範囲の光を透過させるように前記光インターフェイス部を形成するステップをさらに含む、請求項16に記載の方法。
- 18前記光インターフェイス部は、 1 50μm未満の厚さを含む、請求項16に記載の方法。
- 19前記光インターフェイス部の厚さを均一な厚さに形成するステップを含む、請求項16に記載の方法。
- 20前記第1面は前記光センサの表面と一致し、前記第1面は前記光センサと隙間なく同一平面となるように構成される、請求項16に記載の方法。
- 21前記光センサパネルは、円盤形状を含む、請求項1に記載のプローブカバー。
- 22前記プローブカバーの前記第2の部分は、前記封包物の内部に含まれる前記オキシメータ装置の1つ以上の部分の形状と一致する、請求項21に記載のプローブカバー。
- 23前記光センサパネルの第1屈折率と前記オキシメータ装置のプローブ先端のセンサの第2屈折率との差は、50%未満である、請求項1に記載のプローブカバー。
- 24前記プローブカバーの前記第2の開放端への前記第1の開放端の連結は流体封止によって行われる、請求項1に記載のプローブカバー。
- 25前記プローブカバーの前記光センサパネルは、剛性の円盤形状を含む、請求項24に記載のプローブカバー。
- 26前記光インターフェイス部は、オキシメータの測定に減衰影響を与えず、 6 50nm~ 9 00nmの波長範囲の光を透過させる、請求項13に記載のキット。
- 27前記光インターフェイス部は、 1 50μm未満の厚さを含む、請求項13に記載のキット。
- 28前記光インターフェイス部は、 1 00μm未満の厚さを含む、請求項13に記載のキット。
- 29前記光インターフェイス部は、 5 0μm未満の厚さを含む、請求項13に記載のキット。
- 30前記光インターフェイス部の厚さは均一な厚さを含む、請求項13に記載のキット。
- 31前記第1面は前記光センサの表面と一致し、前記第1面は前記光センサと隙間なく同一平面となるように構成される、請求項13に記載のキット。
- 32前記プローブカバーは、ポリカーボネートを含む、請求項13に記載のキット。
- 33前記プローブカバーは、剛性ポリマーを含む、請求項13に記載のキット。
- 34前記光インターフェイス部は、ポリカーボネートを含む、請求項13に記載のキット。
- 35前記防護壁は、剛性ポリマーを含み、前記光インターフェイス部は、前記剛性ポリマーに比べて可撓性ポリマーを含む、請求項13に記載のキット。
- 36前記防護壁は、可撓性ポリマーを含み、前記光インターフェイス部は、前記可撓性ポリマーに比べて剛性ポリマーを含む、請求項13に記載のキット。
- 37前記光インターフェイス部は、円盤形状である、請求項13に記載のキット。
- 38前記円盤形状は剛性である、請求項37に記載のキット。
- 39前記防護壁は、前記光センサによって出射された光エネルギーを前記プローブカバーの前記円盤形状を通って前記組織に入らせるとともに、前記組織によって反射された光エネルギーを前記プローブカバーの前記円盤形状を通って前記光センサに入らせる、請求項38に記載のキット。
- 40前記防護壁は、前記光センサによって出射された光エネルギーを前記プローブカバーの前記光インターフェイス部を通って前記組織にに入らせるとともに、前記組織によって反射された光エネルギーを前記プローブカバーの前記光インターフェイス部を通って前記光センサに入らせる、請求項13に記載のキット。
- 41前記プローブカバーの前記光インターフェイス部は、剛性の円盤形状である、請求項40に記載のプローブカバー。
- 42請求項1に記載のプローブカバーであって、前記オキシメータ装置は、本体部を含み、前記本体部は、第1側面および第2側面によって連結された前方側面および後方側面を含み、前記プローブカバーはさらに、先端部を含み、前記先端部は、前方先端面と、底面とを含み、前記底面は前記前方先端面に連結され、前記底面は前記前方先端面に対して第1転回方向に沿って第1角度で延在し、前記底面は前記オキシメータ装置のセンサヘッドを保持するための開口を含み、前記先端部はさらに、前記底面に連結された後方側面と、前記後方側面に連結された第1指載置面と、前記第1指載置面と前記底面との間の後方先端面とを含み、前記第1指載置面は、前記後方側面に対して前記第1転回方向に沿って第2角度で延在する凹面である、プローブカバー。
- 43前記光センサパネルの第1の材料の第1屈折率と前記オキシメータ装置のプローブ先端の第2の材料の第2屈折率との差は、50%未満である、請求項1に記載のプローブカバー。
Independent claims43
95 paragraphs, as filed
Mutual reference to related applications This application is the United States patent applications filed on April 20, 2016, Nos. 62/325403, 62/325416 and 62/325413, and the United States filed on April 21, 2016. Patent application Nos. 62/325919, Nos. 62/326630 filed on April 22, 2016, Nos. 62/326644 and 62 / 326,673, and No. 62 / filed on July 18, 2016. Claim the priority of No. 363562. These applications are incorporated herein by reference, along with all other references cited in these applications.
INDUSTRIAL APPLICABILITY The present invention relates to a sleeve for covering the oximeter probe while the portable oximeter probe is in use. This sleeve prevents contamination of the oximeter probe with patient tissue or body fluids during use and facilitates reuse of the oximeter probe or portion of the oximeter probe.
<p>An oximeter is a medical device used to measure the oxygen saturation of human and living body tissues for a variety of purposes. For example, an oximeter is an ambulance to monitor hospitals and other medical facilities for medical and diagnostic purposes (eg, operating rooms to monitor surgery, recovery rooms to monitor patients, or hypoxia). Private or home surveillance (eg, general health surveillance, or marathon) of an individual, in a sports stadium for athletic and athletic purposes (eg, to monitor professional athletes), in other mobile facilities). Used for personal training (such as personal training) and for veterinary applications (eg, animal monitoring). In these environments, the oximeter can be contaminated by contact with the patient's tissues and body fluids.</p><p>The oximeter is a relatively expensive device. Therefore, reuse of the oximeter or part of the oximeter can save the cost of medical equipment or other equipment that uses the oximeter. It is desired to further improve the oximeter by providing a reusable oximeter despite the superiority of the existing oximeter.</p><p>Therefore, it is necessary to improve the oximeter and the sleeve that covers the oximeter during use and facilitates reuse of all or part of the oximeter.</p>
<p>INDUSTRIAL APPLICABILITY A sleeve for a portable oximeter probe is provided. This sleeve prevents the patient's tissue and body fluids from penetrating the sleeve and contacting the covered portion of the oximeter probe. The sleeve also prevents prions, viruses, bacteria, fungi, and other biological contaminants from penetrating the sleeve and contacting the covered portion of the oximeter probe. This allows the oximeter probe or part of the oximeter probe to be kept generally clean (eg, hygienic), sterile and / or both during use and can be reused.</p><p>The material of the sleeve has a relatively small pore surface to prevent or prevent various contaminants from passing through the sleeve and contacting the oximeter probe in the sleeve. The pores can prevent blood, blood components, water, bacteria, viruses, or prions from passing through the sleeve.</p><p>The sleeve matches the shape of the oximeter probe. This causes the sleeve to be in relatively close contact with the probe. Therefore, the user can easily grip the sleeve because the oximeter probe does not move inside the sleeve and does not adversely affect the user's grip on the sleeve and the device. The sleeve can include a panel with the general shape of the oximeter probe, or can be expanded and contracted to match the shape of the oximeter probe.</p><p>In one embodiment, the probe cover for the oximeter device includes an open end for inserting the probe tip of the oximeter device into the probe cover, the probe tip including an optical sensor and an optical interface section. The optical interface section is arranged so as to be positioned with respect to the optical sensor of the oximeter device or the probe tip when the probe tip is inserted into the probe cover. The probe cover includes a protective wall connected to the optical interface section. The protective wall prevents contaminants on the tissue as measured by the oximeter device from coming into contact with the probe tip, and the light energy emitted by the photosensor enters the tissue through the optical interface of the probe and tissue. Allows the light energy reflected by the probe to enter the photosensor through the optical interface portion of the probe cover. The optical interface section has a thickness of less than about 250 μm. The difference between the first refractive index of the optical interface section and the second refractive index of the optical sensor is less than 50%. The optical interface section is provided between the first surface and the second surface. The first surface is arranged so as to be positioned with respect to the optical sensor. The second surface is positioned so that it is positioned relative to the tissue. The first and second planes are parallel to each other.</p><p>In one embodiment, the kit comprises an oximeter probe. The oximeter probe includes the main body. The body portion includes a rectangular tubular portion including anterior and posterior flanks connected by a first and second flanks, and a tip. The tip portion includes a first finger mounting surface connected to the front side surface, and the first finger mounting surface is a convex surface extending at a first angle along the first turning direction with respect to the front side surface. The front tip surface includes the front tip surface connected to the first finger mounting surface, and the front tip surface extends at a second angle along the second turning direction with respect to the first finger mounting surface and is connected to the front tip surface. The bottom surface extends at a third angle along the second turning direction with respect to the first finger resting surface, and the bottom surface includes an opening for holding the sensor head of the device, rearward. The second finger mounting surface, including the second finger mounting surface connected to the side surface, is a concave surface extending at a fourth angle along the first turning direction with respect to the rear side surface, and is a second finger mounting surface. The posterior distal surface, including the posterior distal surface connected between the surface and the bottom surface, is a convex surface extending at a fifth angle along the first turning direction with respect to the second finger resting surface.</p><p>The kit includes a probe cover that matches the shape of one or more parts of the oximeter probe. The probe cover includes an open end for inserting the probe tip into the probe cover, the probe tip includes an optical sensor, the probe tip is fully inserted into the probe cover and includes an optical interface section, including an optical interface section. Includes a protective wall that is positioned so as to be positioned relative to the optical sensor of the oximeter device or the probe tip when the probe tip is inserted into the probe cover and is connected to the optical interface section. The protective wall prevents contaminants on the tissue as measured by the oximeter device from coming into contact with the probe tip, and the light energy emitted by the photosensor enters the tissue through the optical interface of the probe and tissue. Allows the light energy reflected by the probe to enter the photosensor through the optical interface portion of the probe cover. The optical interface section has a thickness of less than about 250 μm.</p><p>In one embodiment, the method comprises forming a sleeve. The step of forming the sleeve includes the step of forming the open end of the sleeve into which the probe tip of the oximeter device can be inserted into the probe cover, and the probe tip includes the optical sensor and includes the step of forming the optical interface portion. The optical interface section is arranged so as to be positioned with respect to the optical sensor of the oximeter device or the probe tip when the probe tip is inserted into the probe cover. The step of forming the sleeve includes the step of forming a protective wall connected to the optical interface portion. The protective wall prevents contaminants on the tissue as measured by the oximeter device from coming into contact with the probe tip, and the light energy emitted by the photosensor enters the tissue through the optical interface of the probe and tissue. Allows the light energy reflected by the probe to enter the photosensor through the optical interface portion of the probe cover. The step of forming the sleeve is a step of forming an optical interface portion having a thickness of less than about 250 μm and a step of reducing the difference between the first refractive index of the optical interface portion and the second refractive index of the optical sensor to less than 50%. And a step of forming an optical interface between the first and second surfaces, the first surface is arranged to be positioned relative to the optical sensor and the second surface is relative to the tissue. Includes a step of forming the first and second planes parallel to each other.</p><p>In one embodiment, the sleeve comprises a tubular portion, the tubular portion comprising a front side panel, a rear side panel, a first side panel, and a second side panel. The front side panel and the rear side panel are connected to each other by the first side panel and the second side panel. The sleeve includes the tip. The tip portion is a first finger mounting panel connected to the front side panel, a bottom panel connected to the first finger mounting panel, and a second finger mounting connected between the bottom panel and the rear side panel. Includes a placement panel. The bottom panel has an upper surface and a lower surface that are parallel surfaces. The tubular portion, the first finger mounting panel and the second finger mounting panel are formed from the first material, and the bottom panel is formed from at least the second material. When the oximeter probe is placed on the sleeve, the sleeve matches the shape of the oximeter probe. When the oximeter probe is placed on the sleeve, the bottom panel is positioned so that it is positioned relative to the first surface of the face plate of the oximeter probe. The top and bottom surfaces of the bottom panel are parallel to the first surface of the face plate. The index of refraction of the second material is similar to or similar to the index of refraction of the face plate. The index of refraction of the face plate is about 1 to 1.6, about 1.2 to 1.5, about 1.3 to 1.5, or about 1.33 to about 1.46. The difference in refractive index is about 50% or less, about 40% or less, about 30% or less, about 20% or less, about 10% or less, about 5% or less, about 2.5% or less, about 1% or less, or about 0.5%. It may be less than or equal to, similar or other values. Panels other than the bottom panel are sometimes called protective walls.</p><p>The index of refraction of the face plate and the index of refraction of the other panels of the sleeve may be similar or different. For example, the index of refraction of the face plate may be higher or lower than the other panels of the sleeve. For example, the index of refraction of the panel of the sleeve may be less than about 1.46, less than 1.4, less than about 1.35, less than about 1.3, less than about 1.25, less than about 1.2, less than about 1.1, or any other value of the face plate. The index of refraction may be greater than the index of refraction of other panels.</p><p>The bottom panel is transparent to light with wavelengths from about 650 nm to about 900 nm.</p><p>In one embodiment, the sleeve device for an oximeter probe comprises a rectangular tubular portion, the rectangular tubular portion comprising a front side panel, a rear side panel, a first side panel, and a second side panel. , The front side panel and the rear side panel are connected to each other by the first side panel and the second side panel. The tip includes a first finger resting panel connected to the front side panel. The first finger mounting panel is a convex panel extending at a first angle along the first turning direction with respect to the front side panel. The tip includes a front tip panel connected to the first finger resting panel. The front tip panel extends at a second angle along the second turning direction with respect to the first finger resting panel. The tip includes a bottom panel connected to the front tip panel. The bottom panel extends at a third angle along the second turning direction with respect to the first finger resting panel. The tip includes a second finger resting panel connected between the bottom panel and the rear side panel. The second finger mounting panel is a concave panel extending at a fourth angle along the first turning direction with respect to the rear side panel.</p><p>In one embodiment, the sleeve device for the oximeter probe includes a tubular portion, the tubular portion including a front side panel, a rear side panel, a first side panel, and a second side panel. The front side panel and the back side panel are connected by a first side panel and a second side panel. The first edge of the front side panel, the back side panel, the first side panel and the second side panel form the first opening. The sleeve device includes a top with a cover panel connected to the front side panel via a concave connection. The cover panel extends at a first angle along the first turning direction with respect to the front side panel. The top includes a display cover panel connected to the cover panel via a convex connection. The display cover panel extends at a second angle along the second turning direction with respect to the cover panel. The second edge, rear side panel, first side panel and second side panel of the display cover panel form a second opening distal to the sleeve with respect to the first opening.</p><p>In one embodiment, the sleeve device for an oximeter probe comprises a rectangular tubular portion, the rectangular tubular portion comprising a front side panel, a rear side panel, a first side panel, and a second side panel. .. The front side panel and the rear side panel are connected to each other by the first side panel and the second side panel. The tip includes a first finger resting panel connected to the front side panel. The first finger mounting panel is a convex panel extending at a first angle along the first turning direction with respect to the front side panel. The tip includes a front tip panel connected to the first finger resting panel. The front tip panel extends at a second angle along the second turning direction with respect to the first finger resting panel. The tip panel includes a bottom panel connected to the front tip panel. The bottom panel extends at a third angle along the second turning direction with respect to the first finger resting panel. The front panel includes a second finger resting panel connected between the bottom panel and the rear side panel. The second finger mounting panel is a concave panel extending at a fourth angle along the first turning direction with respect to the rear side panel.</p><p>The sleeve includes a top and the top includes a cover panel connected to the front side panel via a concave connecting portion. The cover panel extends at a fifth angle along the first turning direction with respect to the front side panel. The top includes a display cover panel connected to the cover panel via a convex connection. The display cover panel extends at a sixth angle with respect to the cover panel along the second turning direction. The edges of the display cover panel, the rear side panel, the first side panel, and the second side panel form an opening. This allows the oximeter probe to be inserted into the opening.</p><p>In one embodiment, the kit comprises an oximeter probe and a sleeve configured to cover a portion of the oximeter probe. The sleeve includes a rectangular tubular portion, including a front side panel, a rear side panel, a first side panel, and a second side panel. The front side panel of the sleeve and the rear side panel of the sleeve are connected to each other by a first side panel and a second side panel. The tip of the sleeve includes a first finger resting panel connected to the front side panel. The first finger mounting panel is a convex panel extending at a first angle along the first turning direction with respect to the front side panel. The tip includes a front tip panel connected to the first finger resting panel. The front tip panel extends at a second angle along the second turning direction with respect to the first finger resting panel. The tip includes a bottom panel connected to the front tip panel. The bottom panel extends at a third angle along the second turning direction with respect to the first finger resting panel. The tip includes a second finger resting panel connected between the bottom panel and the rear side panel. The second finger mounting panel is a concave panel extending at a fourth angle along the first turning direction with respect to the rear side panel. The kit includes an instruction manual for operating the oximeter probe and an instruction manual for operating the sleeve. The kit includes a battery to power the oximeter probe. The kit can include one or more "easy" cards with brief instructions for operating the oximeter probe or sleeve. The simplified instruction is an abbreviation for the instruction in the instruction manual.</p><p>Other objects, features and advantages of the invention will become apparent in light of the following detailed description and accompanying drawings. In drawings, similar reference symbols represent similar features in all drawings.</p>
<figref num="1">In one embodiment, it is a diagram showing a probe tip of an oximeter probe covered with a sleeve.</figref><figref num="2A">It is a perspective view which shows the sleeve.</figref><figref num="2B">It is a side view which shows the sleeve.</figref><figref num="3">In one embodiment, it is a diagram showing a probe tip and a probe unit of an oximeter probe covered with a sleeve.</figref><figref num="4">In one embodiment, it is a diagram showing a probe tip and a probe unit of an oximeter probe covered by a top sleeve and a bottom sleeve.</figref><figref num="5">It is a figure which shows the top sleeve and the bottom sleeve which covers the probe tip of an oximeter probe and the probe unit (the probe tip is removable to the probe unit).</figref><figref num="6">FIG. 5 shows a probe unit covered by a top sleeve and an uncovered removable probe tip for quick and easy replacement of the removable probe tip.</figref><figref num="7">It is a figure which shows the oximeter probe (indicated by a dotted line) and the sleeve which covers a part of an oximeter probe.</figref><figref num="8">It is a perspective view which shows the sleeve.</figref><figref num="9">It is a figure which shows the sleeve which has the adhesive strip for adhering the sleeve to an oximeter probe.</figref><figref num="10">In one embodiment, it is a diagram showing a sleeve.</figref><figref num="11">It is a perspective view which shows the bottom part of a sleeve.</figref><figref num="12">In one embodiment, it is a diagram showing a sleeve and an oximeter probe arranged inside the sleeve.</figref><figref num="13">In one embodiment, it is a diagram showing a sleeve and an oximeter probe arranged inside the sleeve.</figref><figref num="14">In one embodiment, it is a diagram showing a sleeve and an oximeter probe arranged inside the sleeve.</figref><figref num="15">It is a figure which shows the kit which includes an oximeter probe and a sleeve, and is sold as a shipping unit.</figref>
Detailed Description of the Invention The present invention generally relates to a sleeve or sheath for covering a portion of the oximeter probe or oximeter probe so that the oximeter probe or portion of the oximeter probe can be reused. During use, the sleeve acts as a protective barrier to maintain hygiene and sterility (eg, prevent the spread of pathogens) while allowing all the functionality of the oximeter probe (eg, optically transparent). do. The sleeve prevents the patient's tissue and fluid from coming into contact with the portion of the oximeter probe covered by the sleeve. The sleeve also prevents one or more of prions, viruses, bacteria, fungi, and other biological contaminants from coming into contact with the oximeter probe or parts thereof. Therefore, the sleeve facilitates reuse of the oximeter probe or part thereof after use, rather than discarding the oximeter probe or part thereof.
FIG. 1 shows the oximeter probe 101. This oximeter probe is used to measure the oxygen saturation of the target tissue. In one embodiment, the oximeter probe is a tissue oximeter. In another embodiment, the oximeter probe is a pulse oximeter.
The oximeter probe 101 has two parts, namely a probe unit 105 and a probe tip 110. The probe unit forms the upper part of the oximeter probe, and the probe tip forms the lower part of the oximeter probe. In one embodiment, the user can remove the probe tip from the probe unit and replace the probe tip with a different probe tip. When the probe unit and probe tip are attached together, the oximeter probe operates as a stand-alone portable oximeter without the need to connect to another unit with a cable. In some embodiments, the probe tip is not removable from the probe unit.
The oximeter probe has a display 115 (eg, an LCD display such as a touch LED display) and a button 120. When the button is pressed, light rays, infrared rays (IR), or both are emitted from the probe tip to the tissue to be measured, and the light rays or IR reflected from the tissue to be measured are received by the probe tip. The oximeter probe measures the oxygen saturation of the tissue from the light received or IR. Indicators (eg, numerical or graphic indicators) indicating the measured oxygen saturation are displayed on the display.
The following patent applications describe various oximeter devices and oxygen measuring operations, and the discussions in the following patent applications can be combined with any combination of aspects of the invention described herein. The following patent applications, namely Patent Application No. 14/944139 filed on November 17, 2015, No. 13/887130 filed on May 3, 2013, filed on May 24, 2016: No. 15/163565, No. 13/887220 filed on May 3, 2013, No. 15/214355 filed on July 19, 2016, No. 13 filed on May 3, 2013. / 887213, No. 14/977578 filed on December 21, 2015, No. 13/887178 filed on June 7, 2013, No. 15/220354 filed on July 26, 2016. No. 13, No. 13/965156 filed on August 12, 2013, No. 15/359570 filed on November 22, 2016, No. 13/887152 filed on May 3, 2013, No. 29/561749 filed April 16, 2016, No. 61/642389 No. 61/642393 filed May 3, 2012, No. 61/642395, No. 61/642399, and 2012. No. 61/682146, filed August 10, is incorporated herein by reference, along with all references cited in these applications.
The present application describes some examples of embodiments with specific dimensions, measurements and values. These examples are not intended to be exhaustive or strictly limited to the embodiments described.
Some measurements are in millimeters and angles are degrees and approximations. These values may vary, for example, due to measurement or manufacturing tolerances or other factors (eg ± 5%, ± 10%, ± 15%, or ± 20%). Moreover, these measurements are for the device of a particular embodiment, other embodiments differing, for example, by making some dimensions larger to accommodate larger hands or devices. Can have.
In the specific embodiments described, some specific values, range values and numerical values are provided. These values indicate, for example, dimensions, angles, ranges, frequencies, wavelengths, numbers, and other quantities (eg, the number of sensors, light sources, detectors, diodes, fiber optic cables, etc.). Some measurements are for the device of a particular embodiment, while others are, for example, larger or smaller in some dimensions to accommodate larger sized products. Different values can be obtained by making some dimensions smaller to accommodate the product. By adjusting the relative measurements proportionally (eg, by maintaining similar or similar ratios between different measurements), the device can be proportionally increased or decreased. In various embodiments, the value (numerical value or quantity), like the predetermined value, may be similar to the predetermined value, may be greater than or equal to the predetermined value, or less than or equal to the predetermined value, or may be any combination thereof. .. The value (numerical value or quantity) may be in the range consisting of any two predetermined values or in the range including the two predetermined values.
Figure 1 shows a sleeve placed over the probe tip.<u style="Single">220</u>Is shown. The sleeve has a closed body and an open top. The sleeve covers the probe surface (not shown) located at the bottom of the probe tip and extends upward along the length of the probe tip. The body has a shape complementary to the portion of the oximeter probe covered by the sleeve. The oximeter probe is inserted into the sleeve through the open top. An elastic band (not shown) can be placed just below the open top to secure the sleeve to the oximeter probe. Other fastening devices, such as adhesives, O-rings, or other mechanical devices, can be used to secure the sleeve to the oximeter probe.
In one embodiment, the probe unit 105 has a shaft 600 extending downward from the bottom of the probe unit to the top of the probe tip 110. The shaft 600 has a generally rectangular shape with a front surface 610, a rear surface 615 (not shown in FIG. 1, but indicated by an arrow with reference number 615), and (shown in FIG. 1). Includes a first side surface 620 (indicated by an arrow with reference number 620, but not) and a second side surface 625. The front and rear surfaces are connected by a first side surface and a second side surface. The front and back surfaces are wider than the first and second sides.
The probe tip 110 has a first finger resting surface (eg, a thumb resting surface) 630 and an anterior tip surface 635 (not shown in FIG. 1, but indicated by an arrow with reference number 640). A bottom surface 640, a second finger resting surface 645 (not shown in FIG. 1, indicated by an arrow with reference number 645), and a reference number 650 (not shown in FIG. 1, but indicated by a reference number 645). Includes a third side 650 (indicated by an arrow with) and a fourth side 655.
The first finger mounting panel 630 has a convex surface and is connected to the front surface 610 via the concave surface. The first finger resting surface is along the first turning direction (eg, clockwise direction of arrow 664) with respect to the front side surface as viewed from the second side surface 625 of the shaft 600 and the fourth side surface 655 of the probe tip 110. It extends at the first turn angle of 662. The first finger resting surface can be configured to fit the user's thumb.
The front tip surface 635 is the second turning direction (eg, clockwise direction of arrow 668) with respect to the first finger mounting surface 630 as viewed from the second side surface 625 of the shaft 600 and the fourth side surface 655 of the probe tip 110. Extends along with a second turn angle of 666.
The bottom surface 640 is at a third turning angle along a second turning direction (eg, clockwise) with respect to the front tip surface 635 as viewed from the second side surface 625 of the shaft 600 and the fourth side surface 655 of the probe tip 110. It is postponed.
The second finger resting surface 645 is a concave surface at a fourth turning angle along the second turning direction with respect to the bottom surface 620 as viewed from the second side surface 625 of the shaft 600 and the fourth side surface 655 of the probe tip 110. It is postponed. In one embodiment, the second finger resting surface is a flat or convex surface. The user's finger (eg, the middle finger) that supports the oximeter probe is placed on this concave surface.
The rear surface 615 extends at a fifth turning angle along the second turning direction with respect to the second finger resting surface 645 as viewed from the second side surface 625 of the shaft 600 and the fourth side surface 655 of the probe tip 110.
In various embodiments, the posterior flanks and bottom surface are relatively flat surfaces with angles ranging from 90 ° to about 150 ° to each other. The first height of the first finger position above the bottom surface is larger than the second height of the second finger position above the bottom surface. The first turning angle is an angle formed in the range of 90 ° to about 60 ° with respect to the front side surface.
Figures 2A and 2B show sleeves, respectively.<u style="Single">220</u>It is a perspective view and a side view which shows. The dashed line in FIG. 2A shows the characteristics of the sleeve that are not visible in the perspective view of the illustrated sleeve.
In one embodiment, the sleeve<u style="Single">220</u>Has a panel corresponding to the surface of the oximeter probe and a contour and a turning angle corresponding to the contour and turning angle of the oximeter probe. Specifically, the sleeves are the front panel 710, the rear panel 715, the first upper side panel 720, the second upper side panel 725, the first finger panel 730, and the front.<u style="Single">Tip</u>It includes a panel 735, a bottom panel 740, a second finger resting panel 745, a first lower side panel 750, and a second lower side panel 755. The first upper side panel and the first lower side panel are sometimes referred to as the first side panel. The second upper side panel and the second lower side panel are sometimes referred to as the second side panel.
The first finger mounting panel 730 is convex and is connected to the front side panel 710 via the concave surface. The first finger resting panel is first along the first turning direction (eg, clockwise direction of arrow 764a) with respect to the front side panel as viewed from the second upper side panel 725 and the second lower side panel 755. It extends at a turning angle of 762a. The first finger resting panel may be configured to come into contact with the user's thumb while the first finger resting surface 630 is supported by the user's thumb.
The front tip panel 735 is along a second direction (eg, clockwise with arrow 764b) with respect to the first finger resting panel 730 as viewed from the second upper side panel 725 and the second lower side panel 755. It extends at a second turn angle of 762b.
The bottom panel 740 is a relatively flat panel (eg, flat) in the second turning direction (eg, clockwise with arrow 764c) as seen from the second upper side panel 725 and the second lower side panel 755. 3rd turn angle along<u style="Single">762c</u>It is extended in.
The bottom panel is configured to lie relatively flat (eg, without voids) with respect to the probe surface of the oximeter probe. The bottom panel can be made of the same or different material as the other panels. The bottom panel can be made of glass, quartz, polycarbonate, epoxy (eg, with polished top and bottom), or other material. The bottom panel will be further described below.
The second finger mounting panel 745 is a concave panel and is viewed from the second upper side panel 725 and the second lower side panel 755 in the second turning direction (eg, clockwise direction of arrow 764d) with respect to the bottom panel 740. ) 4th turn angle<u style="Single">762d</u>It is extended in. The second finger placement panel can contact the user's middle finger while the oximeter probe is placed on the index finger. The concave second finger placement panel can have a radius that matches or matches the radius of the second finger placement surface 645 of the oximeter probe. For example, the radius of curvature of the concave panel may range from 1 centimeter (eg, relatively large curvature) to about 10 meters (eg, relatively small curvature). Alternatively, the second finger resting panel may be flat, convex, or any combination of the shapes described above. If the second finger mounting surface 645 of the oximeter probe is convex, the convex panel can have a radius that matches or matches the radius of the second finger mounting surface 645. For example, the radius of curvature of a convex panel may range from 1 centimeter (eg, a relatively large curvature) to about 10 meters (eg, a relatively small curvature).
The rear panel 715 is located along the second turning direction (eg, the clockwise turning direction of arrow 764e) with respect to the second finger resting panel 745 as viewed from the second upper side panel 725 and the second lower side panel 755. 5 turning angle<u style="Single">762e</u>It is extended in.
In one embodiment, the top opening can have a diameter of about 2-10 cm or a lateral length (each length of panels 710, 715, 720 and 725). The body of the sleeve can have a length in the range of about 2 cm to 40 cm. FIG. 1 shows multiple lengths of various embodiments of the sleeve (eg, first length, second length, third length and fourth length). For example, the length of the first sleeve may be about 1.5 cm to about 5 cm, the length of the second sleeve may be about 2.5 cm to about 20 cm, and the length of the third sleeve may be. It may be about 3.5 cm to about 30 cm, and the length of the fourth sleeve may be about 4.5 cm to about 40 cm.
These different length sleeves have different usage conditions, such as a dry usage environment where no fluid is present and does not scatter on the oximetry probe, or a wet usage environment where the oximeter probe may come into contact with the patient's body fluids. May be used in. For example, a relatively short sleeve may be used in the former usage environment, and a longer sleeve may be used in the latter usage environment.
The sleeve is made of a flexible material, rubber material, plastic or plastic material, relatively rigid material or other material that prevents the patient's tissue and body fluids from coming into contact with the portion of the oximeter probe covered by the sleeve. Will be done. The sleeve can prevent one or more of prions, viruses, bacteria, fungi and other contaminants from coming into contact with the portion of the oximeter probe covered by the sleeve.
The sleeve is a polycarbonate, latex rubber, polyurethane, polyethylene, nitrile, silicon, polymer that prevents tissues, body fluids, prions, viruses, bacteria, fungi or other contaminants from coming into contact with the covered area of the oximeter probe. , Plastics, cellophane, polyethylene films, combinations of ethylene methyl acrylate polymers with polyethylene films, polyester films such as Mylar, or other substances. As mentioned above, the bottom panel of the sleeve is made of a material similar to or different from the other panels of the sleeve, such as glass, quartz, polycarbonate, epoxy (eg with polished top and bottom), or other material. can do. The sleeve or probe cover can include any combination of the materials described above. For example, the sleeve can include polycarbonate and polyurethane or polyethylene.
The sleeve can match the shape of the oximeter probe. For example, the sleeve can be provided to fold or roll flat and open to accommodate the oximeter probe. When provided in a rolled-up form, the sleeve can be opened to cover the oximeter probe to match the probe during use, and the sleeve can be opened or detached from the oximeter probe after use. In addition, if one or more panels are stretchable, the sleeve can be stretched when the oximeter probe is inserted into the opening of the sleeve, and then the oximeter probe is retracted by the contraction of the one or more panels. Can match the shape of.
Panels on the sleeve can be formed on a continuous, seamless material, or on multiple panels connected by adhesive, epoxy, sonic welding, or other connecting materials and techniques. The panel can be made of similar or different materials.
In one embodiment, the sleeve can be formed of a material having a pore size of about 100 nm or less, about 50 nm or less, about 20 nm or less to block the virus, or about to block the smallest known virus. It can be formed of a material having a pore size of 15 nm or less. In one embodiment, to block proteins such as prions, the sleeve is made of a material with a pore size of about 5-10 nm or less. In one embodiment, to block fluids such as water, the sleeve is made of a material with a pore size of about 0.30 to 0.25 nm or less.
With sleeves, various environments such as spot measurements, doctor's offices, sporting events (eg personal and professional sports applications), homes, nursing homes, hospice care, first responders (eg emergency doctors, emergency medical technicians) , Ambulance care, firefighters), preoperative care, postoperative care, pediatric care, geriatric care, medical rehabilitation centers, veterinary applications, and parts of oximeter probes or probes in sterile surgical environments for other applications. Can be protected. The environment in which the oximeter probe covered by the sleeve is used ranges from a sterile environment to a generally hygienic and clean environment (eg, sterile recovery room in a hospital, examination room and other medical offices, home use and other environments). , And generally unsanitary environments such as mud, dust, sand and dusty environments, snow (ski resorts, ski patrols, mountain climbing, etc.), rain, ice, battlefield applications, and water areas (eg swimming pools). , Beach, boat). Different sleeve materials, such as the sleeve materials described above, can be used to make sleeves for specific sterile or hygienic applications.
To keep the sleeve sterile before use, the sleeve can be supplied in hygienic enclosures. The encapsulation may be paper, plastic coated paper, plastic, myra, or other material.
Figure 3 shows a sleeve with a length that extends almost to the top of the oximeter probe.<u style="Single">320</u>An embodiment is shown. sleeve<u style="Single">320</u>The lower part of is the sleeve mentioned above<u style="Single">220</u>Has similar or similar contours and turning angles. Also, the sleeve<u style="Single">320</u>Has a sleeve extension over the shaft 600 (eg, a sleeve extension of a front panel 710, a rear panel 715, a first upper side panel 720 and a second upper side panel 725).
Also, the sleeve<u style="Single">320</u>Includes a plurality of panels covering all or part of the probe unit 105. Specifically, the sleeves are labeled with a button panel 770, a third side panel 775 (not shown in FIG. 1, but indicated by an arrow with reference number 775), and a fourth side panel 780. Includes panel 785. The button panel 770 may be a relatively flat panel and may have a contour adapted to the button 120, eg, a contour complementary to the shape of the button 120. The button panel 770 is connected to the third side panel 775 via the convex surface and is connected to the fourth side panel 780 via the convex surface. The button panel, the third side panel and the fourth side panel 780 are each connected to the display panel 785 via a convex surface.
The third side panel 775 is connected to the first top panel 720 via a relatively flat connection, and the fourth side panel 780 is connected to the second upper side panel 725 via a relatively flat connection. To. sleeve<u style="Single">320</u>Is the top of the display panel, the top of the first upper side panel and the second upper side panel, and the rear panel.<u style="Single">715</u>Includes a top opening 225 provided at the top of the. The oximeter probe is inserted into the sleeve through the opening.
In one embodiment, the top opening 225 can be sealed if it is desired to encapsulate the entire oximeter probe in a sleeve. After placing the oximeter probe on the sleeve, an elastic band can be used to seal the apex opening. In one embodiment, the sleeve comprises an attached flap that can be sealed by covering the top opening. This flap seals the top opening. The flap can seal the top opening either on the flap or via an adhesive provided on the rest of the sleeve. For ease of use, the adhesive may be protected by a non-adhesive pull strip.
In one embodiment, if the sleeve covers the display, at least the display panel of the sleeve is transparent or sufficient to visible light so that the user can see the display through the sleeve (eg, at least the display panel of the sleeve). It is translucent. Also, the sleeve or at least the bottom panel (eg, face plate) 740 is transparent to the radiation emitted from the oximeter probe to the target tissue. For example, the sleeve, bottom panel, or both are transparent to visible light, IR, or both. For example, the sleeve, bottom panel, or both are about 760 nm and 810 nm, about 760 nm, 810 nm and 850 nm, about 760 nm, 810 nm, 850 nm and 900 nm, 650 nm and about 900 nm, about 670 nm and about 900 nm, about 690 nm and about. 900nm, about 700nm and 900nm, about 710nm and about 900nm, about 720nm and 900nm, 730nm and 900nm, 750nm and 900nm, 760nm and 900nm, 770nm and 900nm, or other ranges, such as about 650nm and about 890nm, about 670nm and about. Longest wavelengths less than 890nm, about 690nm and about 890nm, about 700nm and 890nm, about 710nm and about 890nm, about 720nm and 890nm, 730nm and 890nm, 740nm and 890nm, 750nm and 890nm, 760nm and 890nm, 770nm and 890nm, or less than 890nm. Transparent to other ranges of light, IR, or both. The listed wavelengths and wavelength ranges are emitted from the oximeter probe, passed through the patient tissue and then received by the oximeter probe. The face plate is 90% or more, 92% or more, 94% or more, 95% or more, 96% or more, 97% or more, 98% or more, 99% (for example, 90% or more of the incident light passes through the face plate). Above, 99. Has a transmittance of 5% or more or other transmittance. That is, the attenuation of the face plate is 10% or less, 8% or less, 6% or less, 5% or less, 4% or less, 3% or less, 2% or less, 1.5% or less, 1% or less, 0.5% or less, or other. The value.
The face plate of the sleeve and other panels can have similar or different refractive indexes and can have similar or different thicknesses. For example, the display panel and the face plate can have different refractive indexes (eg, the face plate can have a higher index of refraction than the other panels on the sleeve). The face plate and other panels of the sleeve can have different thicknesses. For example, the face plate may be thinner than the other panels of the sleeve by 10%, 20%, 50%, 100%, 200%, 300%, 1000%, 2000%, or other differences.
FIG. 4 shows an embodiment of a bottom sleeve 305 and a top sleeve 310 overlapping along a portion of an oximeter probe. The bottom sleeve 305 can cover the tip of the probe and part of the probe unit, eg, the entire or part of the shaft 600. Bottom sleeve 305 is a sleeve<u style="Single">220</u>Can have a height similar to or similar to (eg, longer or shorter). The top sleeve 310 can cover all or part of the probe unit 105 and all or part of the shaft 600. The top sleeve is shown in Figure 3 and is the sleeve described above.<u style="Single">320</u>It may be similar to or similar to the top of the.
One or both of these sleeves can have elastic bands, O-rings, adhesives, or other devices to secure the sleeve to the oximeter probe. For example, the illustrated top sleeve is an elastic band for fixing the top sleeve to the oximeter probe.<u style="Single">322</u>Have. For inserting the oximeter probe into the sleeve, the top sleeve can include a top opening 325. The overlap of these sleeves allows the oximeter probe to be easily placed on the sleeve, preventing contaminants from contacting the oximeter probe and facilitating reuse of the oximeter probe. ..
FIG. 5 shows a two-part oximeter probe 501. The two parts include the probe unit 505 and the probe tip 510 removable from the probe unit. When attached, the probe unit and probe tip form an actual oximeter probe 501. Any of the sleeves described above, such as the bottom sleeve 305 and the top sleeve 310, can be used with the oximeter probe 501.
FIG. 6 shows an oximeter probe 501 with a probe unit 505 and a probe tip 510 removable from the probe unit. In one embodiment, the top sleeve 310 covers the probe unit 505 so as to cover or not cover the top of the probe tip. Replacing the probe tips relatively quickly, for example with multiple probe tips supplied as multiple cartridges in the probe tray, by partially covering or not covering the probe tips with a sleeve. It can be done easily. The probe tip can be stored in a sterile environment within the probe tray prior to use. After use, the used probe tip can be discarded and a different sterile probe tip can be removed from the probe tray and attached to the probe unit. In this embodiment, the probe tip and the probe tray are the cartridge probe tip and the cartridge probe tray.
In one embodiment, the bottom panel (eg, portion) of the sleeve that emits light from a light source and covers the probe tip detected by the detector is a rigid, transparent element, such as a rigid, relatively thin plastic element or rigid. Contains relatively thin glass elements. A portion of the sleeve containing the cover may slide from the probe tip or in a plane different from the plane of the light source and detector (eg, non-planar) by snap-fitting to the probe tip or otherwise fitting to the probe tip. It can be configured to prevent it from being located at the tip of the probe. The bottom panel can include a ring made of a rigid material. This ring holds the inner flexible panel flat while pulling. The ring can be configured to snap into the probe tip of the oximeter device.
In one embodiment, a material layer can be provided between the probe surface at the probe tip and the sleeve. The index of refraction of this material layer is similar to or similar to the index of refraction of the sleeve, the index of refraction of the epoxy layer that can be provided above the light source and the detector, or both. The index of refraction of the sleeve may be in the range of about 1.2 to about 1.46. The epoxy layer on the surface of the probe tip may have a similar index of refraction range. The difference in refractive index between the sleeve and the epoxy layer at the tip of the probe may be 0.1 to 0.2. The fluid or gel placed between the shield and the epoxy layer can have a similar index of refraction.
The material layer may be a fluid, liquid, gel, or other material. The material layer improves the optical coupling between the light source and the detector and the tissue and sleeve by suppressing the reflection between the sleeve and the light source and the reflection between the sleeve and the detector. Also, the interface material between the sleeve and the probe surface can prevent or reduce folding, gathering, or bunching of the sleeve material that can interfere with the transmission of light.
FIG. 7 shows the oximeter probe 801 (indicated by the dashed line) and the sleeve 820 covering a portion of the oximeter probe. FIG. 8 is a perspective view showing the sleeve.
The oximeter probe 801 includes a probe unit 805, a probe tip 810, and a shaft 818 extending from the bottom of the probe unit to the top of the probe tip. The oximeter probe includes a display 815 that can be used from outside the probe unit. In one embodiment, the sleeve covers the probe tip and a portion of the shaft of the oximeter probe.
Sleeve 820 is a sleeve<u style="Single">220</u>Can have a similar shape or a different shape. Instead, the sleeve 820 is a sleeve<u style="Single">220</u>Can have a different shape from. For example, sleeve<u style="Single">220</u>And the contours of one or more panels of the sleeve 820 (eg, concave panel, convex panel, concave panel connection, and convex panel connection) may be similar, similar, or different. good. Also, the turning angle of the sleeve 820 is the sleeve.<u style="Single">220</u>It may be the same as or different from the turning angle of. For example, the first turning angle between the first finger resting panel and the front side panel may be similar or different (eg, sleeve 820 is larger). Also, the second turning angle between the front tip panel and the first finger resting panel may be similar or different (eg, sleeve 820 is larger). The third turn angle between the bottom panel and the second anterior tip panel may be similar or different (eg, sleeve 820 is smaller). The fourth turning angle between the second finger resting panel and the bottom panel may be similar or different (eg, sleeve 820 is larger). The fifth turning angle between the rear panel and the second finger resting panel may be similar or different (eg, sleeve 820 is larger).
The sleeve 820 is flexible and can be formed from one or more of the materials described herein. Alternatively, the sleeve 820 may be a relatively rigid sleeve made of a relatively rigid material such as rigid plastic or a plastic-like material, for example polycarbonate.
sleeve<u style="Single">820</u>Can include a mounting device 835 for fixing the sleeve to the oximeter probe. The device 835 is an O-ring device, an adhesive, a ridge or ridge (eg, meshing with a trench having a complementary shape formed on the shaft of an oximeter probe), and a ridge (eg, a ridge having a complementary shape formed on the shaft). It may be a trench (meshing), or other device, or any combination of these devices.
FIG. 9 shows a sleeve 820 with an adhesive strip 835 for fixing the sleeve to the oximeter probe. The adhesive strip can be covered with a non-adhesive cover. This non-adhesive cover can be removed from the adhesive strip before connecting the sleeve to the oximeter probe.
FIG. 10 shows a sleeve 920 in one embodiment. The sleeve 920 can include contours and turning angles similar to or similar to the sleeve 820 and may be flexible or relatively rigid made of materials similar to or similar to the sleeve 820.
Sleeve 920 has an oximeter probe on the sleeve<u style="Single">801</u>Includes device 935 for gluing to. The device 935 may be a magnet that is magnetically coupled to the magnetic material of the oximeter probe (eg, a ferromagnetic material or a permanent magnet), or the oximeter probe is a magnet that is magnetically coupled to the magnetic material of the sleeve. May have.
Alternatively, the device 935 may be a protrusion for connecting to an oximeter probe (eg, a recess on the shaft) or a recess for connecting to an oximeter probe (eg, a protrusion on the shaft). The device 935 may be a soft material configured to deform into a depression or protrusion, or a rigid material configured to deform the sleeve to adhere the device to the depression or protrusion. Buttons can be formed on the outer surface of the sleeve by placing the device on the inner surface of the sleeve or extending in the thickness direction of the sleeve. This allows the sleeve to be easily attached to or removed from the oximeter probe.
FIG. 11 shows a lower perspective view of the sleeve 920 in one embodiment. FIG. 11 is a perspective view showing the bottom panel 940 and the second finger resting panel 945 as well as the other panels of the sleeve. The bottom panel 940 may have a disc shape (or other shape) made of a relatively rigid or deformable material (eg, a hardness of about 30-100 in shore indentation hardness). The surfaces of the top (eg, inside the sleeve) and bottom (eg, outside the sleeve) of the bottom panel 940 may be flat or parallel, respectively. The bottom panel thickness T may range from about 25 μm to about 500 μm or other thicknesses. For example, the thickness of the bottom panel is about 50 μm or less, 75 μm or less, about 100 μm or less, 125 μm or less, 150 μm, 175 μm, 200 μm, 225 μm, 250 μm or less, 275 μm or less, 300 μm or less, 325 μm, 350 μm, 375 μm, 400 μm, 450 μm, It may be 500 μm or other thickness.
The bottom panel is configured to have an orientation relatively parallel to the probe surface of the oximeter probe when the sleeve is connected to the oximeter probe. The parallel configuration allows the bottom panel and the probe surface to be connected without trapping air between the surface of the bottom panel and the surface of the probe surface.
The bottom panel and the probe surface can have a similar index of refraction (eg, a permissible variation of 0.1-0.2). This makes it possible to know and control the direction of light from the probe surface to the tissue and the direction of light from the tissue to the probe surface. By eliminating the void between the bottom panel and the probe surface, it is possible to predict the traveling direction of light passing between the probe surface, the bottom panel and any of the tissues. By keeping the direction of light traveling between these elements constant, the accuracy of measuring tissue properties (eg, oxygen saturation) can be improved.
In one embodiment, the index of refraction of the bottom panel is the index of refraction of the face plate of the oximeter probe (a polished face plate, eg, a polished epoxy layer; light passes through the face plate and is detected by the oximeter probe). The same is true. The index of refraction of the bottom panel may be in the range of about 1.33 to about 1.46. The index of refraction difference between the bottom panel and the surface of the probe tip (eg, the epoxy layer) may be 0.1-0.2. The bottom panel of each of the described sleeves (eg, sleeves 120, 220 and 820) can be similarly configured. Also, the bottom panel is transparent to the wavelength of light (eg, IR) emitted by the oximeter probe, reflected from the target tissue, and traveling through the bottom panel to the oximeter probe. For example, the sleeve, bottom panel, or both have wavelengths in the range of about 700 nm to about 890 nm, about 760 nm to about 850 nm, about 760 nm to about 890 nm, about 760 nm to about 900 nm, about 760 nm to about 810 nm, about 760 nm, 810 nm, Transparent to 850 nm, and 900 nm, any combination of these wavelengths, or other wavelengths.
The fluid or gel placed between the shield and the epoxy layer can have a similar index of refraction with similar variations. The fluid or gel can improve the optical coupling between the light source and detector and the tissue and sleeve by suppressing the reflection between the bottom panel and the surface of the probe tip. The fluid or gel can also prevent or reduce folding, gathering, or bunching of the sleeve material that can interfere with the transmission of light.
In one embodiment, the bottom panel of the sleeve comprises a pressure sensor 942. The pressure sensor can be placed between the bottom panel 940 and the other panel of the sleeve to which the bottom panel is connected. The pressure sensor 942 can be placed on the bottom surface of the bottom panel. The pressure sensor can be formed as a ring (eg, a circle or other shape) placed on both sides of the bottom panel. The pressure sensor may be a piezoelectric material, a piezo resistance material, or the like that detects pressure through changes in the electrical properties of the material. The sleeve can include an electrical trace for transferring electrical signals from the pressure sensor to the oximeter probe for displaying pressure information on the display. The pressure information displayed on the display indicates whether the pressure of the oximeter probe has changed the blood volume or blood flow velocity to the target tissue because the oximeter probe presses on the target tissue with excessive pressure. Also, the pressure information on the display indicates whether the light emitted by the oximeter probe is bound to the target tissue in an unpredictable way because the oximeter probe presses on the target tissue with too low a pressure.
In one embodiment, the sleeve comprises a light source. The light source can be placed on one of the panels of the sleeve so that when the light source is turned on, the light emitted from the light source is directed at the target tissue. The light source can be turned off when the oximeter probe makes an oxygen saturation measurement. Thereby, the light emitted from the light source does not affect the oxygen saturation measurement value. The light source may be an LED including a power source and a power switch for controlling the on / off of the light source.
In one embodiment, the sleeve comprises one or more features, elements (eg, a device), or a combination of the features and the device to prohibit the reuse of the sleeve removed from the oximeter probe. By prohibiting the reuse of the removed sleeve, cross-contamination of tissues, fluids and other contaminants between different patients and between the environment of use and the patient can be suppressed. In one embodiment, if the sleeve includes two connectable parts (eg, upper sleeve and lower sleeve), the connectable part of the sleeve will be damaged when the sleeve is separated and removed from the oximeter device. It is composed. For example, an adhesive that joins two parts of a sleeve can be inactivated after separating the two parts. This prevents the adhesive from adhering for secondary use. The adhesive can have a stronger adhesive strength than the tear strength of the sleeve material. As a result, the sleeve tears when removed from the oximeter probe. Further, the sleeve material can include, for example, a material having a preferential tearing direction along the length of the sleeve. Therefore, when the sleeve is removed from the oximeter probe, the sleeve tears along the preferred tearing direction rather than the joining direction of the junction.
In one embodiment, the sleeve comprises an electron detector for detecting whether or not the oximeter probe is located within the sleeve. The sleeve can include a detector (eg, pressure sensor, photodetector, etc.) for detecting that the oximeter probe is placed within the sleeve. When attempting to reuse the sleeve, when placing another oximeter probe on the sleeve, the electronic detector will indicate that this sleeve has been used in the past (audible, lit, tactile, display, these. Can be given (combined with indicators). The sleeve includes a detector, which has already used this sleeve with an oximeter probe by detecting that the upper hinge of the sleeve has been opened, closed and then reopened. Can be shown. The sleeve can provide any indicator of past use.
FIG. 12 shows, in one embodiment, a sleeve 1220 and an oximeter probe 801 located inside the sleeve. The sleeve 1220 surrounds the oximeter probe 801 (eg, the entire oximeter probe) inside the sleeve. The sleeve 1220 includes an upper sleeve 1231 and a lower sleeve 1233.
In one embodiment, the lower sleeve 1233 is a sleeve.<u style="Single">220</u>Includes panels similar to or similar to. For example, the lower sleeve 1233 has a front panel 1210, a rear panel 1215 (not shown in FIG. 12, but indicated by an arrow with reference number 1215), and a rear panel 1215 (not shown in FIG. 12). The first upper side panel 1222 (indicated by the arrow with reference number 1222), the second upper side panel 1225, the first finger panel 1230, and the anterior top panel 1235 (not shown in FIG. 12). The bottom panel 1240 (indicated by the arrow with reference number 1240) and the second finger resting panel 1245 (not shown in FIG. 12, but indicated by the arrow with reference number 1245), and the first. A lower side panel 1250 and a second lower side panel 1255 can be included. The first upper side panel and the first lower side panel are sometimes referred to as the first side panel. The second upper side panel and the second lower side panel are sometimes referred to as the second side panel. The panel of the lower sleeve 1233 is the sleeve mentioned above.<u style="Single">220</u>Like, it can have similar or different contours and turning angles.
The upper sleeve 1231 includes a third side panel 1260, a fourth side panel 1265, and a fifth side panel 1270 (not shown in FIG. 12, but indicated by an arrow with reference number 1270). Includes a sixth side panel 1275 (not shown in 12 but indicated by an arrow with reference number 1275) and a display panel 1280. The upper sleeve can also include a connecting panel 1285 (eg, a slope panel) for connecting the third panel, the fourth panel, the fifth panel and the sixth panel to the display panel. Instead, the third panel, the fourth panel, the fifth panel and the sixth panel are connected to the display panel by the convex connecting portion.
The third side panel is connected to the fourth side panel by a convex connection or other shaped connection, and the fourth side panel is connected to the fifth side panel by a convex connection or other shaped connection. The fifth side panel is connected to the sixth side panel by a convex connection or other shaped connection, and the sixth side panel is connected to the third side panel by a convex connection or other shaped connection. ..
The 3rd side panel, 4th side panel, 5th side panel and 6th side panel are almost flush with each of the front panel 1210, the rear panel 1215, the 1st upper side panel 1222 and the 2nd upper side panel 1225. It may be tilted (eg, beveled) with respect to the front and rear panels as well as the first upper side panel and the second upper side panel, as well as the front and rear panels via the convex connection. It can be connected to the first upper side panel and the second upper side panel, and may be a combination of these shapes or other shapes. The display panel may have a shape complementary to the shape of the display of the oximeter probe and may be relatively flat or curved.
The upper and lower sleeves can be separated into separate sleeves or may be connected by two or more panels of the upper and lower sleeves (eg, hinged by a sleeve material). For example, the rear panels 1215 and the fifth side panel 1270 can be hinged, the side panels 1222 and 1275 can be hinged, the front panels 1210 and 1260 can be hinged, and the side panels 1225 and 1265 can be hinged. Can be hinged together, and these panels can be hinged together in other combinations.
The hinged panels can be opened and closed via hinges. This allows the oximeter probe to be inserted into and removed from the sleeve 1220. When the upper and lower sleeves are closed (eg, as shown in FIG. 12), a visible seam 1290 is formed between the upper and lower sleeves. For example, if the upper and lower sleeves are completely separable, the seam 1290 extends all around the top of the sleeve 1220 when the upper and lower sleeves are closed. If two panels (eg, panels 1215 and 1270) are hinged, the seam 1290 extends over three or less non-hinged sides. For example, if the rear panel 1215 and the fifth side panel 1270 are hinged together, the seam 1290 extends along the front and sides of the sleeve 1220, but the rear surface of the sleeve (eg, the rear panel 1215 and the fifth side). It does not extend along panel 1270).
The seam is above the center of the sleeve 1220, for example, at least 20% of the total height of the sleeve and above the center of the sleeve 1220.
In one embodiment, the display panel 1280 operates as a hinge panel. When the display panel acts as a hinge panel, the seam 1290 includes a seam portion 1290a extending upward along the fourth side panel 1265 and upward along the sixth side panel 1275.
One or more surfaces of the panel can have an adhesive. This allows the unconnected panels of the upper and lower sleeves to be glued together with an adhesive. By gluing these panels together, the upper and lower sleeves can be prevented from inadvertently separating or opening, and the oximeter probe can be held within the sleeve to prevent contamination. The adhesive may be provided near the seam 1290 and may be protected by a non-adhesive film that can be easily removed by the user prior to using the sleeve with the oximeter probe. Alternatively, the upper and lower sleeves can contain an adhesive of m that adheres to the oximeter probe to secure the sleeve to the probe. Alternatively, the upper and lower sleeves can include an elastic band to secure the sleeve to the oximeter probe, or can include other devices for integrating the sleeve and probe in use. In one embodiment, if the upper and lower sleeves are made of a relatively rigid material, such as a polycarbonate, the upper and lower sleeves are formed (eg, on the upper and lower edges of the upper and lower sleeves). Can be slip-fitted (via complementary shaped ledges), can be glued together, and connected by mechanical elements (eg, latches, fasteners, or other connectors) or other connectors. Can be done.
The upper sleeve and lower sleeve can be formed of any of the materials used for the sleeve panels described. The upper and lower sleeves can be made of similar or different materials. Both the upper and lower sleeves may be relatively flexible, relatively rigid, or flexible and rigid (eg, the upper sleeve is rigid and the lower sleeve is flexible). It may be sex or the upper sleeve is flexible and the lower sleeve is rigid). The bottom panel 1240 may be formed or function as described above with respect to the bottom panel 940 shown in FIG.
FIG. 13 shows, in one embodiment, a sleeve 1320 and an oximeter probe 801 located inside the sleeve. The sleeve 1320 surrounds the oximeter probe 801 (eg, the entire oximeter probe) inside the sleeve. The sleeve 1320 includes a body sleeve 1301 and a flap sleeve 1303.
The body sleeve 1301 can include one or more panels described above for various embodiments. The body sleeve can have the various contours and turning angles described above. In addition, the body sleeve and flap sleeve panels can be formed from any one or more of the various combinations described above, eg, the various flexible materials described above or the various rigid materials described above.
The body sleeve and flap sleeve may be connected to each other (eg, hinged) such that the oximeter probe is placed in the sleeve and removed from the sleeve. The body sleeve and flap sleeve may be hinged at the top 1391 of the display panel 1380 and the top 1393 of the flap sleeve 1303. The body sleeve and flap sleeve may be hinged at the bottom 1397 of the rear panel 1315 and flap sleeve 1303. In other embodiments, the sleeves may be connected at other parts of the sleeve.
The body sleeve, flap sleeve, or both can be provided with an adhesive on one or more surfaces to bond the sleeves to each other. The adhesive can be covered with a release cover. This allows the release cover to be peeled off and adhered before using the oximeter probe with the sleeve. One or both of the body and the flap sleeve can include other devices (eg, mechanical devices) capable of connecting the flap sleeve to the body sleeve in the closed position.
The flap sleeve may be a sleeve that can be separated from the main body sleeve, or may be an adhesive sleeve. An adhesive can be provided on one or more surfaces of the body sleeve and one or both of the body sleeve and the flap sleeve to bond the body sleeve and the flap sleeve to each other. The flap sleeve can be adhered to the body sleeve by exposing the adhesive and pressing the flap sleeve against the body sleeve. Due to the tensile force from the user, the bond can be separated relatively easily. The adhesive can seal the oximeter probe to the sleeve. A seal can be formed by using other devices, such as complementary mechanical contours, O-rings, or other elements formed in each portion, together with the upper sleeve portion and the lower sleeve portion.
In one embodiment, the rear panel 1315 has an upper panel portion 1315a and a lower panel portion 1315b. The flap sleeve 1303 has an upper panel portion 1303a and a lower panel portion 1303b. The upper and lower panel sections of the rear panel and flap sleeve, respectively, may be relatively flat (eg, as shown in FIG. 13), curved, or in a combination of flat and curved. There may be. The upper and lower panel portions of the rear panel 1315 and flap sleeve 1303, respectively, can be angled with each other at an angle of about 170 ° to about 90 °, for example, an angle of about 130 ° to about 140 °.
FIG. 14 shows, in one embodiment, a sleeve 1420 and an oximeter probe 801 disposed inside the sleeve. The sleeve 1420 surrounds the oximeter probe 801 (eg, the entire oximeter probe) inside the sleeve. The sleeve 1420 includes an upper sleeve 1431 and a lower sleeve 1433. The upper sleeve and the lower sleeve are separable sleeves. By separating the upper sleeve and the lower sleeve, the oximeter probe can be placed inside the sleeve and the oximeter probe can be removed from the sleeve. In order to use the oximeter probe in the sleeve, the upper sleeve and the lower sleeve can be integrally connected.
The upper sleeve 1431 may be similar to or similar to the upper portion of the sleeve 1231, eg, a portion of the sleeve 1231 above the first finger rest 1230. The lower sleeve 1433 may be similar to or similar to the lower sleeve 1233.
By connecting the upper sleeve 1431 and the lower sleeve 1433, a visible seam 1490 that extends around the sleeve 1420 (eg, extends all around the sleeve at the center of the sleeve 1420) is formed. The seam can be located above or below the center of the sleeve in the central area of the sleeve 1420, eg, 20% or more of the total height of the sleeve.
The upper and lower sleeves may be one or more O-rings 1435, one or more adhesive strips, one or more mechanical devices (detents, buttons, latches, fasteners, or anything else), magnetic fasteners, or It can be connected to the oximeter probe via other devices. The upper and lower sleeves can be connected to each other by adhesives, mechanical connectors, sliding fits (eg, sliding fits between a portion of one sleeve and the other sleeve), or other devices.
The upper sleeve and lower sleeve can be formed of any of the materials used for the sleeve panels described. The upper and lower sleeves can be made of similar or different materials. Both the upper and lower sleeves may be relatively flexible, relatively rigid, or flexible and rigid (eg, the upper sleeve is rigid and the lower sleeve is flexible). It may be sex or the upper sleeve is flexible and the lower sleeve is rigid). The upper and lower sleeves can be made of materials with different porosities.
FIG. 15 shows a kit in one embodiment. The kit can be sold as a shipping unit. The kit includes an oximeter probe 801 and a sleeve 1520. The kit may further include a first instruction manual for using the oximeter probe 1525 and a second instruction manual for using the sleeve. The kit can include a container (eg, box, not shown) that houses the oximeter probe, sleeve, and manual and is sold as a shipping unit. The kit can include, for example, a battery 1530 for use with the oximeter probe if the battery is not in the battery compartment of the oximeter probe when the kit is sold. The battery may be a disposable battery or a rechargeable battery.
The sleeve 1520 may be any of the sleeves described in this patent application. The sleeve can be sealed in a protective container 1522, such as a packet container, which keeps the sleeve sterile before use. This kit includes a large number of sleeves 1520 for use with the oximeter probe, such as 10 sleeves, 20 sleeves, 30 sleeves, 40 sleeves, 50 sleeves, 60 sleeves, 70. It can include 1 sleeve, 80 sleeves, 90 sleeves, 100 sleeves, more or less sleeves. The kit shows additional items such as disinfectant wipes or disinfectant solutions, gloves (eg sterile gloves such as latex, nitrile, vinyl, etc.), normal or range of oxygen saturation, abnormal levels and / or both. Easy Guide 1540 (eg Card), Easy Guide 1545 (eg Card or Page) with simplified instructions for using the oximeter probe, Easy Guide 1550 for using the sleeve, or other items. including. The oximeter probe and sleeve may be an Intra.Ox® oximetry probe and protective sleeve from ViOptix, located in Newark, Calif. The kit may include an oximeter probe and a sleeve, or may include a combination of an oximeter probe and a sleeve and one or more of the described kit elements.
The present invention has been described for purposes of illustration and description, but is not intended to be exhaustive or strictly limited to the described form, and many modifications are made in view of the above teachings. And can be transformed. In order to best explain the principles of the invention and its practical applications, embodiments have been selected and described. This description will allow one of ordinary skill in the art to optimally utilize and implement the invention in various embodiments or with various modifications suitable for a particular application. The various elements of the various embodiments described can be combined or replaced in any combination. The scope of the present invention is defined by the following claims.
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Every citation, both ways
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| JP2005110816A | Cites | Japan |
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| US10932708B2 | United States of America | B2 | |
| US2021077000A1 | United States of America | A1 | |
| TWI730080B | Taiwan Province of China | B | |
| US2021177312A1 | United States of America | A1 | |
| TWI743108B | Taiwan Province of China | B | |
| JP2021184812A | Japan | A | |
| JP6992002B2This record | Japan | B2 | |
| JP6992003B2 | Japan | B2 | |
| TWI754641B | Taiwan Province of China | B | |
| TWI756218B | Taiwan Province of China | B | |
| KR102377230B1 | Republic of Korea | B1 | |
| CN109414226B | China | B | |
| TWI765885B | Taiwan Province of China | B | |
| CN109310341B | China | B | |
| KR102423695B1 | Republic of Korea | B1 | |
| KR102427034B1 | Republic of Korea | B1 | |
| KR102436176B1 | Republic of Korea | B1 | |
| CN109310377B | China | B |
11 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| First payment of annual fees (during grant procedure)JAPANESE INTERMEDIATE CODE: A61A61 | A61 | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Decision of grant or rejection writtenTRDD | TRDD | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Report on retrievalJAPANESE INTERMEDIATE CODE: A971007A977 | A977 | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621 | A621 |
Numbers
- Publication
- 6992002
- Application
- 2018555226
Titles2
- Japanese
- 携帯型オキシメータプローブ用のスリーブ
- English
- Sleeve for portable oximeter probe
Classification
- CPC, 13
- A61B5/14551
- A61B5/14552
- A61B2560/0425
- A61B2562/242
- A61B2562/247
- A61B5/1075
- A61B5/6887
- A61B5/7235
- A61B2560/0214
- A61B5/7225
- A61B5/7445
- A61B2560/0431
- A61B2562/0242
- IPC, 1
- A61B5 1455
