TWI815720B - Signal transmitting element - Google Patents
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- TWI815720B TWI815720B TW111142036A TW111142036A TWI815720B TW I815720 B TWI815720 B TW I815720B TW 111142036 A TW111142036 A TW 111142036A TW 111142036 A TW111142036 A TW 111142036A TW I815720 B TWI815720 B TW I815720B
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Abstract
Description
本發明係關於一種訊號傳輸元件，尤其是一種可於人體內降解的訊號傳輸元件。 The present invention relates to a signal transmission element, in particular to a signal transmission element that is biodegradable in the human body.
在習知血管監測的臨床技術中，為了可自動定時監控受測者經手術後的血管是否有血栓的情形，係運用一種侵入式且部分外露於監測者體外的監測線圈，例如是庫克醫療(Cook Medical)公司所提出的杜普勒血流監測器(Doppler Blood Flow Monitor)及對應的監測線圈(Cool-Swartz Doppler Probe)，該監測線圈的一部分圍繞要監測的血管，該監測線圈的另一部分延伸於體外形成外接線段與對應的監測器連接，並由該監測器透過該監測線圈發出超音波，以獲取被圍繞血管的血流資訊。然而，延伸於體外的外接線段具有容易汙染而引發感染，及易脫落或因拉扯而使血管受傷等風險。此外，當未來不再需要監測目標血管時，還需要再進行額外手術以將對應線圈拆除，而使受監測者再次受傷，且手術過程中仍有可能因拉扯而使血管受傷的風險。 In the conventional clinical technology of vascular monitoring, in order to automatically and regularly monitor whether there are thrombus in the blood vessels of the subject after surgery, an invasive monitoring coil that is partially exposed outside the body of the monitor is used, such as Cook Medical The Doppler Blood Flow Monitor (Doppler Blood Flow Monitor) and the corresponding monitoring coil (Cool-Swartz Doppler Probe) proposed by (Cook Medical) Company, a part of the monitoring coil surrounds the blood vessel to be monitored, and the other part of the monitoring coil A part extends outside the body to form an external line segment and is connected to a corresponding monitor, and the monitor emits ultrasound through the monitoring coil to obtain blood flow information of the surrounding blood vessels. However, the external wire segments extending outside the body have risks such as being easily contaminated and causing infection, and easily falling off or causing blood vessel injuries due to pulling. In addition, when the target blood vessel no longer needs to be monitored in the future, additional surgery will be required to remove the corresponding coil, causing the person being monitored to be injured again, and there is still a risk of blood vessel injury due to pulling during the surgery.
有鑑於此，習知的訊號傳輸元件確實仍有加以改善之必要。 In view of this, there is still a need to improve conventional signal transmission components.
為解決上述問題，本發明的目的是提供一種信號傳輸元件，可在病人術後的特定期間內持續監測目標血管；並在特定期間後在該病人體內 被降解，而不需再進一步開刀取出，可避免再次手術的風險者。 In order to solve the above problems, the object of the present invention is to provide a signal transmission element that can continuously monitor the target blood vessel during a specific period after the patient's surgery; and after the specific period, the target blood vessel can be detected in the patient's body. It is degraded without the need for further surgery to remove it, thus avoiding the risk of re-operation.
本發明的次一目的是提供一種信號傳輸元件，可強化感應血流資訊的訊號強度者。 A second object of the present invention is to provide a signal transmission element that can enhance the signal strength of sensing blood flow information.
本發明的再一目的是提供一種信號傳輸元件，可依據需求強化特定頻率的訊號強度，或提升訊號傳輸頻率的廣度者。 Another object of the present invention is to provide a signal transmission component that can enhance the signal strength of a specific frequency or increase the breadth of the signal transmission frequency according to needs.
本發明的又一目的是提供一種信號傳輸元件，可獲得低電阻、高附著力的訊號傳輸段者。 Another object of the present invention is to provide a signal transmission element that can obtain a signal transmission section with low resistance and high adhesion.
本發明全文所述方向性或其近似用語，例如「前」、「後」、「左」、「右」、「上(頂)」、「下(底)」、「內」、「外」、「側面」等，主要係參考附加圖式的方向，各方向性或其近似用語僅用以輔助說明及理解本發明的各實施例，非用以限制本發明。 Directionality or similar terms are used throughout the present invention, such as "front", "back", "left", "right", "upper (top)", "lower (bottom)", "inner", "outer" , "side", etc. mainly refer to the directions of the attached drawings. Each directionality or its approximate terms are only used to assist in explaining and understanding the various embodiments of the present invention, and are not intended to limit the present invention.
本發明全文所記載的元件及構件使用「一」或「一個」之量詞，僅是為了方便使用且提供本發明範圍的通常意義；於本發明中應被解讀為包括一個或至少一個，且單一的概念也包括複數的情況，除非其明顯意指其他意思。 The use of the quantifier "a" or "an" in the elements and components described throughout the present invention is only for convenience of use and to provide a common sense of the scope of the present invention; in the present invention, it should be interpreted as including one or at least one, and single The concept of also includes the plural unless it is obvious that something else is meant.
本發明全文所述「連接」、「結合」、「組合」、「組裝」、「安裝」及「設置」等近似用語，主要包含連接後仍可不破壞構件地分離，或是連接後使構件不可分離等型態，係本領域中具有通常知識者可以依據欲相連之構件材質或組裝需求予以選擇者。 Approximate terms such as "connection", "combination", "combination", "assembly", "installation" and "setting" used throughout the present invention mainly include the ability to separate the components without destroying them after being connected, or to make the components irreversible after being connected. Separation and other types can be selected by those with ordinary knowledge in the field according to the materials of the components to be connected or the assembly requirements.
本發明全文所述「耦接」用語，包含電性地及/或訊號地直接或間接連接，係本領域中具有通常知識者可以依據使用需求予以選擇者。 The term "coupling" throughout this disclosure includes direct or indirect electrical and/or signal connections, which can be selected by those with ordinary knowledge in the art according to usage requirements.
本發明全文所述有關尺寸規格之定義，係以本發明第一圖為依據，所述「長度」係沿本體之頭部的長度(如標號L11)延伸方向所定義，所述「寬度」係沿本體之頭部或延伸部的寬度(如標號W11或W12)延伸方向所 定義，所述「厚度」係沿本體之頭部或延伸部的厚度(如標號T11或T12)延伸方向所定義。此外，該等尺寸規格的尺寸調整係可以0.1μm作為調整的區間。 The definitions of dimensions and specifications described throughout the present invention are based on the first drawing of the present invention. The "length" is defined along the extension direction of the length of the head of the body (such as the label L 11 ), and the "width" It is defined along the extending direction of the width of the head or extension part of the body (such as mark W 11 or W 12 ), and the "thickness" is defined along the thickness of the head or extension part of the body (such as mark T 11 or T 12 ) defined by the extension direction. In addition, the size adjustment of these size specifications can be 0.1 μm as the adjustment interval.
本發明全文所述「工作頻率」的頻率調整係可以1MHz作為調整的區間；「鍍金溫度」的溫度調整係可以攝氏0.1度作為調整的區間；「時間」的長度調整係可以1秒作為調整的區間；「攪拌速度」的速度調整係可以1rpm作為調整的區間。 The frequency adjustment of the "operating frequency" mentioned in the full text of the present invention can be 1MHz as the adjustment interval; the temperature adjustment of the "gold plating temperature" can be 0.1 degrees Celsius as the adjustment interval; the length adjustment of "time" can be 1 second as the adjustment interval. Interval; the speed adjustment system of "stirring speed" can use 1 rpm as the adjustment interval.
本發明的一種訊號傳輸元件，包含：一本體，係由生物可降解材料製成，且該本體包含：一訊號感應部，具有一特定構造以感應該本體所環繞接觸之一血管中之一血流資訊，以形成一血管訊號；及一訊號傳輸部，耦接該訊號感應部，用於接收該血管訊號，並具有一特定構造以將該血管訊號形成一發送訊號；該本體成一長條狀片體，並具有一頭部與一延伸部自該頭部向外延伸，該延伸部係用於全部或局部環繞該血管，該訊號傳輸部設置於該頭部之中，該訊號感應部設置於該延伸部之中；該延伸部的表面設有多個突出構造，以在該延伸部環繞該血管的狀態中，該多個突出構造的全部或局部係接觸該血管。 A signal transmission element of the present invention includes: a body made of biodegradable materials, and the body includes: a signal sensing part with a specific structure to sense blood in a blood vessel that the body surrounds and contacts. flow information to form a blood vessel signal; and a signal transmission part, coupled to the signal sensing part, for receiving the blood vessel signal, and having a specific structure to form the blood vessel signal into a sending signal; the body is in a long strip shape The sheet body has a head and an extension extending outward from the head. The extension is used to completely or partially surround the blood vessel. The signal transmission part is arranged in the head, and the signal sensing part is arranged In the extension part; a surface of the extension part is provided with a plurality of protruding structures, so that when the extension part surrounds the blood vessel, all or part of the plurality of protruding structures contact the blood vessel.
據此，本發明的訊號傳輸元件，可透過所述層體中的訊號感應部及訊號傳輸部分別感應與發送對應的血管訊號，達成可在病人術後持續監測目標血管的功效；另，透過訊號傳輸元件可在該病人體內被降解，而不需再進一步開刀取出，可達成避免再次手術風險的功效；及透過該本體之整體配置，可易設置於一待測者體內，而達成監測目標血管的功效；以及透過多個突出構造的配置，達成強化該訊號感應部於感應血流資訊之訊號強度的功效。 Accordingly, the signal transmission element of the present invention can respectively sense and transmit corresponding blood vessel signals through the signal sensing part and the signal transmission part in the layer body, thereby achieving the effect of continuously monitoring the target blood vessels after the patient's surgery; in addition, through The signal transmission element can be degraded in the patient's body without the need for further surgery to remove it, which can avoid the risk of re-operation; and through the overall configuration of the body, it can be easily installed in a patient's body to achieve monitoring goals. The function of blood vessels; and through the arrangement of multiple protruding structures, the effect of strengthening the signal intensity of the signal sensing part in sensing blood flow information is achieved.
其中，該頭部具有一長度介於5mm至35mm之間，一寬度 介於5mm至35mm之間，一厚度介於50μm至350μm之間；該延伸部具有一寬度介於2mm至15mm之間，一厚度介於50μm至350μm之間。如此，可透過該本體之整體尺寸的配置，可易設置於一待測者體內，而達成監測目標血管的功效。 Wherein, the head has a length between 5mm and 35mm, and a width Between 5mm and 35mm, a thickness between 50μm and 350μm; the extension has a width between 2mm and 15mm, and a thickness between 50μm and 350μm. In this way, through the configuration of the overall size of the body, it can be easily installed in a subject's body to achieve the effect of monitoring the target blood vessel.
其中，該突出構造的長度介於0.1μm至100μm之間，寬度介於0.1μm至100μm之間，高度介於0.1μm至100μm之間。如此，可透過多個突出構造在尺寸上的配置，達成強化該訊號感應部於感應血流資訊之訊號強度的功效。 Wherein, the length of the protruding structure is between 0.1 μm and 100 μm, the width is between 0.1 μm and 100 μm, and the height is between 0.1 μm and 100 μm. In this way, the effect of enhancing the signal intensity of the signal sensing portion in sensing blood flow information can be achieved through the size arrangement of the plurality of protruding structures.
其中，該本體包含至少一金屬構造，各該至少一金屬構造係由生物可降解之金屬所組成，各該至少一金屬構造包含一訊號傳輸段與一訊號感應段，該訊號傳輸段位於該本體的該頭部，以形成所述訊號傳輸部；該訊號感應段位於該本體的該延伸部，以形成所述訊號感應部；該訊號傳輸段具有一工作頻率，以傳輸該訊號感應段所感應的該血流資訊。如此，可透過該金屬構造之該訊號傳輸段與訊號感應段，達成感應血流資訊及傳輸該血流資訊的功效。 Wherein, the body includes at least one metal structure, each of the at least one metal structure is composed of biodegradable metal, each of the at least one metal structure includes a signal transmission section and a signal induction section, the signal transmission section is located on the body The head is to form the signal transmission part; the signal induction section is located at the extension part of the body to form the signal induction part; the signal transmission section has an operating frequency to transmit the signal sensed by the signal induction section of the blood flow information. In this way, the effects of sensing blood flow information and transmitting blood flow information can be achieved through the signal transmission section and signal sensing section of the metal structure.
其中，在該本體具有多個金屬構造的配置中，多個金屬構造中之一者的該工作頻率係與該多個金屬構造中之另一者的該工作頻率為相同或不同。如此，可透過多個金屬構造的訊號傳輸段的工作頻率為相同，可達成強化該工作頻率訊號傳輸強度的功效；或，可透過多個金屬構造的訊號傳輸段的工作頻率為不同，可達成提升訊號傳輸頻率廣度的功效。 Wherein, in a configuration in which the body has a plurality of metal structures, the operating frequency of one of the plurality of metal structures is the same as or different from the operating frequency of another of the plurality of metal structures. In this way, the working frequency of the signal transmission sections of multiple metal structures can be the same, which can achieve the effect of enhancing the signal transmission intensity of the working frequency; or, the working frequencies of the signal transmission sections of multiple metal structures can be different, which can achieve Improve the efficiency of signal transmission frequency breadth.
其中，所述該工作頻率介於350MHz至450MHz之間。如此，透過所述工作頻率範圍，可達成以穩定訊號品質進行訊號傳輸的功效。 Wherein, the working frequency is between 350MHz and 450MHz. In this way, through the operating frequency range, signal transmission with stable signal quality can be achieved.
其中，所述該工作頻率介於401MHz至406MHz之間。如此，透過所述工作頻率範圍，可達成以穩定訊號品質進行訊號傳輸的功效。 Wherein, the working frequency is between 401MHz and 406MHz. In this way, through the operating frequency range, signal transmission with stable signal quality can be achieved.
其中，各該至少一金屬構造的材料係至少選自鎂或鎂合金。如此，透過該金屬構造的材料選擇，可達成使該金屬構造為生物可降解材料，並達成感應與傳輸目標血管之血流資訊的功效。 Wherein, the material of each of the at least one metal structure is at least selected from magnesium or magnesium alloy. In this way, through the material selection of the metal structure, the metal structure can be made of biodegradable material, and the effect of sensing and transmitting blood flow information of the target blood vessel can be achieved.
其中，該訊號傳輸元件另包含一鍍金層披覆於該至少一金屬構造中的至少一者的一表面。如此，可透過該鍍金層，達成降低反射損失、具有較低阻抗、提升輻射效率及降低阻抗損失的功效。 Wherein, the signal transmission element further includes a gold plating layer covering a surface of at least one of the at least one metal structure. In this way, through the gold plating layer, the effects of reducing reflection loss, having lower impedance, improving radiation efficiency, and reducing impedance loss can be achieved.
其中，該鍍金層的厚度介於0.01μm至10μm之間。如此，可透過該鍍金層，達成降低反射損失、具有較低阻抗、提升輻射效率及降低阻抗損失的功效。 Wherein, the thickness of the gold plating layer is between 0.01 μm and 10 μm. In this way, through the gold plating layer, the effects of reducing reflection loss, having lower impedance, improving radiation efficiency, and reducing impedance loss can be achieved.
其中，以一特定條件形成該鍍金層，該特定條件包含一鍍金溫度為15℃至35℃、一前處理時間為60秒至150秒、一鍍金時間為45秒至75秒及一攪拌速度為100rpm至300rpm。如此，可透過該特定條件，達成獲得低電阻、高附著力的訊號傳段的功效。 Wherein, the gold plating layer is formed under a specific condition, and the specific conditions include a gold plating temperature of 15°C to 35°C, a pretreatment time of 60 seconds to 150 seconds, a gold plating time of 45 seconds to 75 seconds, and a stirring speed of 100rpm to 300rpm. In this way, the effect of obtaining a signal transmission section with low resistance and high adhesion can be achieved through this specific condition.
其中，以一特定條件形成該鍍金層，該特定條件包含一鍍金溫度為25℃、一前處理時間為120秒、一鍍金時間為60秒及一攪拌速度為150rpm。如此，可透過該特定條件，達成獲得低電阻、高附著力的訊號傳段的功效。 The gold plating layer is formed under a specific condition, which includes a gold plating temperature of 25° C., a pretreatment time of 120 seconds, a gold plating time of 60 seconds, and a stirring speed of 150 rpm. In this way, the effect of obtaining a signal transmission section with low resistance and high adhesion can be achieved through this specific condition.
其中，該本體包含一第一保護層、一第二保護層，該至少一金屬層包覆於該第一保護層與該第二保護層之中；該突出構造之材料係由聚己內酯所製成；該第一保護層與該第二保護層的材料係至少選自聚羥基丁酸酯與聚羥基戊酸酯中之一者。如此，可透過該金屬層包覆於該第一保護層與該第二保護層之中，達成使該金屬層較不易受人體環境的干擾。另，透過該第一保護層、該第二保護層之中及該突出構造之材料選擇，可達成使該本體為生物可降解材料的功效。 Wherein, the body includes a first protective layer and a second protective layer, and the at least one metal layer is covered in the first protective layer and the second protective layer; the material of the protruding structure is made of polycaprolactone The material of the first protective layer and the second protective layer is at least one selected from the group consisting of polyhydroxybutyrate and polyhydroxyvalerate. In this way, the metal layer can be covered in the first protective layer and the second protective layer, so that the metal layer is less susceptible to interference from the human body environment. In addition, through the selection of materials in the first protective layer, the second protective layer and the protruding structure, the effect of making the body a biodegradable material can be achieved.
其中，在該本體具有多個金屬構造的配置中，相鄰的二金屬層之間具有一絕緣層，該絕緣層的材料係由聚左旋乳酸所製成。如此，可透過該絕緣層的設計，電性隔絕相鄰的二金屬構造，達成避免相鄰的二金屬構造間的訊號彼此干擾的功效。 Wherein, in a configuration in which the body has multiple metal structures, there is an insulating layer between two adjacent metal layers, and the material of the insulating layer is made of poly-L-lactic acid. In this way, the two adjacent metal structures can be electrically isolated through the design of the insulating layer, thereby achieving the effect of preventing signals between the two adjacent metal structures from interfering with each other.
其中，在該本體具有多個金屬構造的配置中，相鄰的二金屬層之間具有一絕緣層，該絕緣層的材料係由聚左旋乳酸所製成；該第一保護層與該第二保護層各具有一厚度不大於100μm；該金屬構造的厚度介於10μm至100μm之間；該絕緣層的厚度不大於100μm。如此，可透過上述尺寸的配置，使訊號傳輸元件中各層或各部分的構造與功能可被實現，而達成設置於一待測者體內並監測目標血管的功效。 Wherein, in a configuration in which the body has multiple metal structures, there is an insulating layer between two adjacent metal layers, and the material of the insulating layer is made of poly-L-lactic acid; the first protective layer and the second Each protective layer has a thickness of no more than 100 μm; the thickness of the metal structure is between 10 μm and 100 μm; and the thickness of the insulating layer is no more than 100 μm. In this way, through the configuration of the above dimensions, the structure and function of each layer or part of the signal transmission element can be realized, so as to achieve the effect of being placed in a subject's body and monitoring the target blood vessel.
1:本體 1: Ontology
11:頭部 11:Head
12:延伸部 12:Extension part
2:血管 2: blood vessels
3:突出構造 3: Prominent structure
4:第一保護層 4: First protective layer
5:第二保護層 5: Second protective layer
6:金屬構造 6: Metal structure
6a:訊號傳輸段 6a: Signal transmission section
6b:訊號感應段 6b: Signal sensing section
7:絕緣層 7: Insulation layer
L11:長度 L 11 :Length
W11,W12:寬度 W 11 , W 12 : Width
T11,T12:厚度 T 11 , T 12 : Thickness
STP:訊號傳輸部 STP: Signal Transmission Department
SSP:訊號感應部 SSP: Signal Sensing Part
〔第1圖〕本發明之訊號傳輸元件一較佳實施例的立體示意圖。 [Figure 1] A schematic three-dimensional view of a preferred embodiment of the signal transmission element of the present invention.
〔第2圖〕如第1圖所示之訊號傳輸元件在使用狀態之示意圖。 [Figure 2] A schematic diagram of the signal transmission component shown in Figure 1 in use.
〔第3圖〕本發明之訊號傳輸元件之本體中所包含的層體構造的一範例。 [Figure 3] An example of the layer structure included in the body of the signal transmission element of the present invention.
〔第4圖〕本發明之訊號傳輸元件之本體中所包含的層體構造的另一範例。 [Figure 4] Another example of the layer structure included in the body of the signal transmission element of the present invention.
〔第5圖〕本發明之金屬構造中的訊號傳輸段具有天線構造的一示意圖。 [Figure 5] A schematic diagram of the antenna structure in the signal transmission section in the metal structure of the present invention.
為讓本發明之上述及其他目的、特徵及優點能更明顯易懂，下文特舉本發明之較佳實施例，並配合所附圖式作詳細說明；此外，在不同圖式中標示相同符號者視為相同，會省略其說明。 In order to make the above and other objects, features and advantages of the present invention more obvious and understandable, preferred embodiments of the present invention are illustrated below and described in detail with reference to the accompanying drawings; in addition, the same symbols are used in different drawings. are considered to be the same and their description will be omitted.
請參照第1、2圖所示，其係分別顯示本發明一較佳實施例的
訊號傳輸元件及其使用狀態，該訊號傳輸元件具有一本體1，較佳成一長條狀的片體，以用於局部環繞一血管2。
Please refer to Figures 1 and 2, which respectively show a preferred embodiment of the present invention.
A signal transmission element and its use state. The signal transmission element has a
特別是，該本體1由生物可降解材料製成，較佳是由多個層體所形成(如第3、4圖所示)，且該本體1，特別是該多個層體中的至少一個，具有一訊號傳輸部STP(Signal Transmitting Portion)及一訊號感應部SSP(Signal Sensing Portion)。該訊號傳輸部STP用於將所接收的一血管訊號轉換成對應的一發送訊號，且該發送訊號係用於傳輸一訊號辨識設備(未顯示)，特別是設置於人體外的一訊號辨識設備，並透過所述訊號辨識設備(例如是無線射頻辨識設備)接收並分析該發送訊號，以獲取對應的血流資訊，並可進一步做為評估對應血管是否健康的參考。該訊號感應部SSP用於感應該血管2中之一血流資訊，以將該血流資訊轉換為該血管訊號，並透過該訊號感應部SSP與該訊號傳輸部STP為耦接(特別是直接連接)的配置，該訊號感應部SSP將該血管訊號傳遞到該訊號傳輸部STP。特別是，在該本體1環繞該血管2的狀態中，該訊號感應部SSP係對應的環繞該血管2。如此，透過上述生物可降解的該訊號傳輸部STP及該訊號感應部SSP，可在一病人術後的一特定期間內達成持續監測目標血管2的功效；並在該特定期間後，本發明之訊號傳輸元件可在該病人體內被降解，而不需再進一步開刀取出，具有避免再次手術風險的功效。
In particular, the
詳言之，該本體1具有一頭部11與一延伸部12自該頭部11向外延伸，該延伸部12係用於全部或局部環繞該血管2；特別是，當該延伸部12環繞該血管2時，該延伸部12的形成一環體；其中，在該延伸部12形成一環體時，該延伸部12的一自由端可固定於該延伸部12本身的一適當部位，且所對應的固定方法係可依實際狀況選擇，本發明並不加以限定。較佳地，該訊號傳輸部STP設置於該頭部11之中，該訊號感應部SSP設置於該
延伸部12之中。較佳地，該頭部11具有一長度L11介於5mm~35mm之間，一寬度W11介於5mm~35mm之間，一厚度T11介於50μm~350μm之間；該延伸部12具有一寬度W12介於2mm~15mm之間，一厚度T12介於50μm~350μm之間。
In detail, the
較佳地，該延伸部12的表面設有多個突出構造3；特別是，該多個突出構造3設置於對應於該血管2的位置，以在該延伸部12環繞該血管2時，該多個突出構造3的全部或局部係接觸該血管2。詳言之，在該延伸部12環繞該血管2時，該延伸部12環繞該血管2的部分與該血管2接觸，且該多個突出構造3的全部或局部係接觸該血管2；特別是，與該血管2接觸的該多個突出構造3較該血管延伸部12係更緊密地與該血管2接觸。如此，藉由該多個突出構造3與該血管2的接觸，可強化該訊號感應部SSP於感應該血流資訊的訊號強度。可選地，該突出構造3具有圓柱形、半圓形、半橢圓形、梯形等形狀，惟並不以上述形狀為限。較佳地，該突出構造3的長度介於0.1μm~100μm之間，寬度介於0.1μm~100μm之間，高度介於0.1μm~100μm之間。
Preferably, the surface of the
請參照第3圖所示，其係本發明訊號傳輸元件之層體配置，該本體1(所述由生物可降解材料形成的多個層體)包含一第一保護層4、一第二保護層5及至少一金屬構造6，各該至少一金屬構造6，可例如形成一層體，包覆於該第一保護層4與該第二保護層5之中。應注意的是，該至少一金屬構造6的數量可以是一個或多個。在該至少一金屬構造6的數量為多個的情形中，該多個金屬構造6呈兩兩堆疊的配置，且相鄰的二金屬構造6之間具有一絕緣層7，以電性隔絕相鄰的二金屬構造6，避免相鄰的二金屬構造6間的訊號彼此干擾。較佳地，如第3圖所示，該至少一金屬構造6的數量為二個，且相鄰的二金屬構造6之間具有一絕緣層7。在另一範例中，如第4圖
所示，該至少一金屬構造6的數量為一個。較佳地，該第一保護層4與該第二保護層5各具有一厚度不大於100μm。較佳地，該金屬構造6的厚度介於10μm~100μm之間。較佳地，該絕緣層7的厚度不大於100μm。
Please refer to Figure 3, which is the layer configuration of the signal transmission element of the present invention. The body 1 (the plurality of layers formed of biodegradable materials) includes a first
詳言之，該第一保護層4、該第二保護層5、各該至少一金屬構造6及/或該絕緣層7係形成對應該頭部11與該延伸部12的配置。特別是，該第一保護層4與該第二保護層5的尺寸與形狀係對應該本體1。各該至少一金屬構造6係形成如一層狀/片狀，各該至少一金屬構造6的形狀係對應該第一保護層4與該第二保護層5，且各該至少一金屬構造6的尺寸係小於該第一保護層4與該第二保護層5，以將該金屬構造6包覆於該第一保護層4與該第二保護層5之中。該絕緣層7的形狀係對應其所相鄰的二金屬構造6，該絕緣層7的尺寸係不小於其所相鄰的二金屬構造6，且該絕緣層7的尺寸係不大於該第一保護層4與該第二保護層5，以將相鄰的二金屬構造6絕緣地隔開，且該絕緣層7被包覆於該第一保護層4與該第二保護層5之中。此外，各該至少一金屬構造6具有一訊號傳輸段6a與一訊號感應段6b；該訊號傳輸段6a位於該本體1的該頭部11，以形成所述訊號傳輸部STP；該訊號感應段6b位於該本體1的該延伸部12，以形成所述訊號感應部SSP。換言之，該本體1具有該至少一金屬構造6，該訊號傳輸部STP係由該訊號傳輸段6a所形成，該訊號感應部SSP係由該訊號感應段6b所形成。較佳地，該訊號傳輸段6a具有一長度介於1mm~35mm之間，一寬度介於1mm~35mm之間；更佳地，該訊號傳輸段6a的該長度為10mm，該寬度為10mm。
Specifically, the first
詳言之，該訊號感應段6b，可例如形成一單一線段(惟，亦可形成多線段)，分布於該本體1用於環繞該血管2的區域。該訊號傳輸段6a與該訊號感應段6b連接，以接收該訊號感應段6b所感應的訊號(特別指該血管2中的血流資訊)，且該訊號傳輸段6a具有一工作頻率/傳輸頻率，以
傳輸該訊號感應段6b所感應的訊號。特別是，如第5圖所示，該訊號傳輸段6a係成一天線構造，該天線構造較佳是形成平面天線(Flat Antenna/Planar Antenna)的構造；所述工作頻率可透過該訊號傳輸段6a所具有的天線圖樣/形狀(Antenna Pattern)而決定；換言之，在同樣材質與尺度下，可透過不同的天線圖樣得到不同的工作頻率；所述天線圖樣可以例如是以方形迴圈、圓形迴圈、三角形迴圈、非對稱迴圈、及其他圖樣中至少一者所構成。較佳地，所述工作頻率介於350MHz~450MHz之間；更佳地，所述工作頻率介於401MHz~406MHz之間。如此，在所述工作頻率範圍中，可使該訊號傳輸段6a能以穩定的訊號品質進行訊號傳輸。
Specifically, the
應注意的是，在該本體1具有多個金屬構造6的配置中，該多個金屬構造6中之一者的該工作頻率係與該多個金屬構造6中之另一者的該工作頻率為相同或不同。詳言之，在具有三個金屬構造以上的態樣中，所述工作頻率可以完全相同、完全不同或局部相同，且所述「局部相同」係指至少二個金屬構造6的工作頻率相同且不同於其他金屬構造6的工作頻率；在僅具有二個金屬構造6的態樣中，該二個金屬構造6的工作頻率僅為全部相同或全部不同。在工作頻率相同的狀態下，可強化該工作頻率的訊號傳輸強度，特別適用於訊號傳輸元件裝設於人體較深處的情形；在工作頻率不同的狀態下，可提升訊號傳輸頻率的廣度。如此，可視本發明訊號傳輸元件位於人體內環境的狀態，決定各該金屬構造6的工作頻率是否相同，以提升訊號傳輸的品質。
It should be noted that in a configuration in which the
詳言之，該突出構造3、該第一保護層4、該第二保護層5、該金屬構造6及該絕緣層7係由具有生物可降解性的材料所製成，特別可例如是經過美國食品藥物管理局(FDA)認可之材料；較佳地，所述具有生物可降解性的材料在人體中的降解時間大致上為六個月。該突出構造3之材料係至
少可選自聚己內酯(PCL)。該第一保護層4與該第二保護層5的材料係至少可選自聚羥基丁酸酯(PHB)與聚羥基戊酸酯(PHV)中之一者。該金屬構造6係由生物可降解之金屬所組成，所述生物可降解之金屬的材料係至少可選自鎂或鎂合金，特別是使該金屬構造6係由鎂線或鎂合金線所形成；可選地，為增強該金屬構造6所感應的訊號的傳導，可另將一表面處理層(未顯示)形成於該金屬構造的表面，特別是透過該表面處理層的形成，可降低該金屬構造6的電阻值；另，該表面處理層係具有不影響該金屬構造6內部材料降解之材料或構造；較佳地，所述表面處理層為一鍍金層(Gold-plated Layer)且披覆於該金屬構造6的表面，例如於所述鎂線或鎂合金線表面鍍上金以形成鍍金之鎂線或鎂合金線，且透過使該鍍金層在一定厚度範圍中，而使該金屬構造6內部材料可經降解而為人體所吸收；該鍍金層之厚度介於0.01μm~10μm之間。更佳地，該絕緣層7的材料係至少可選自聚左旋乳酸(PLLA)。
Specifically, the protruding
應注意的是，以該金屬構造6為鎂線，且對應的表面處理層為鍍金層為例，鎂線鍍金後(所述鍍金之鎂線)與鎂線鍍金前(單純僅有鎂材質的金屬線)相比，在反射損失(Return Loss)及阻抗參數(Impedance Parameter)的特性是更佳的。所述反射損失的值越低表示傳遞過程反射越少訊號回來。所述阻抗參數係用於觀察天線在各頻段之匹配狀況，當特定頻段的實部阻抗與虛部阻抗越高，表示天線於該特定頻段會有較強的電感性和電容性產生，使天線更不易匹配於該特定頻段，實際操作時會較容易有雜訊與共振的情形；此時，發出訊號的入射波就會發生反射，造成訊號損失。特別是，在所述鍍金層厚度介於0.01μm~10μm之間時，可以控制該金屬構造6整體電阻值為0.1歐姆~0.3歐姆，達成較佳的訊號傳遞效果。
It should be noted that, taking the
此外，在比較鎂線鍍金後與鍍金前之天線輻射效率的實驗模擬中，鎂線鍍金後改善了Z軸方向的輻射效率，並改善了鎂線鍍金前天線輻射 場型的扭曲與不飽和性。其中，對應的天線輻射效率可由公式(1)計算，對應的阻抗損失可由公式(2)計算，並由上述公式可推導出，材料導線性增加可提升幅射效率並降低阻抗損失，並可藉此作為本發明之傳感器於植入人體環境後之訊號感測特性的參考。 In addition, in the experimental simulation comparing the radiation efficiency of the antenna after gold plating the magnesium wire and before gold plating, the radiation efficiency in the Z-axis direction was improved after gold plating the magnesium wire, and the radiation efficiency of the antenna before gold plating was improved. Distortion and unsaturation of the field pattern. Among them, the corresponding antenna radiation efficiency can be calculated by formula (1), and the corresponding impedance loss can be calculated by formula (2), and it can be deduced from the above formula that increasing the conductivity of the material can improve the radiation efficiency and reduce the impedance loss, and can be borrowed This serves as a reference for the signal sensing characteristics of the sensor of the present invention after being implanted in the human body environment.
輻射效率的公式：
其中，ηradiation代表輻射效率；c 0代表光速；μ 0代表真空導磁率；c代表天線寬度；r 0輻射場型半徑；σ代表材料導電性；f0代表工作頻率；h代表天線厚度；δ代表介電常數。 Among them, eta radiation represents the radiation efficiency; c 0 represents the speed of light; μ 0 represents the vacuum permeability; c represents the antenna width; r 0 radiation field radius; σ represents the material conductivity; f 0 represents the operating frequency; h represents the antenna thickness; δ represents the dielectric constant.
阻抗損失的公式：
其中，Rloss代表阻抗損失；r 0輻射場型半徑；σ代表材料導電性；c eff 代表天線寬度的一半；h代表天線厚度；δ代表介電常數。 Among them, R loss represents the impedance loss; r 0 radiation field radius; σ represents the material conductivity; c eff represents half of the antenna width; h represents the antenna thickness; δ represents the dielectric constant.
應注意的是，將前述鎂金屬線鍍金的過程中，係透過特定的鍍金溫度、前處理時間、鍍金時間、攪拌速度進行，並以獲得較低的阻抗值、鍍金結構較不易剝落、較高訊號雜訊比的結果為較佳。據此，本發明提出一較佳鍍金方法是在鍍金溫度為15℃~35℃、前處理時間為60秒~150秒、鍍金時間為45秒~75秒及攪拌速度為100rpm~300rpm進行，可獲得電阻不超過0.3歐姆，經附著力測試後的實際鍍金破損面積小於5%；換言之，透過上述特定的鍍金條件，可獲得低電阻、高附著力的該訊號傳輸段6a。
It should be noted that the process of gold plating the aforementioned magnesium metal wire is carried out through specific gold plating temperature, pre-treatment time, gold plating time, and stirring speed, so as to obtain a lower impedance value, a gold-plated structure that is less likely to peel off, and a higher The signal-to-noise ratio results are better. Accordingly, the present invention proposes a better gold plating method which is carried out when the gold plating temperature is 15°C to 35°C, the pretreatment time is 60 seconds to 150 seconds, the gold plating time is 45 seconds to 75 seconds, and the stirring speed is 100rpm to 300rpm. The obtained resistance does not exceed 0.3 ohms, and the actual gold plating damage area after adhesion testing is less than 5%; in other words, through the above-mentioned specific gold plating conditions, the
更佳地，所述鍍金溫度為25℃、前處理時間為120秒、鍍金時間為60秒及攪拌速度為150rpm。其中，下表一呈現各處理參數組合的實驗結果。 More preferably, the gold plating temperature is 25°C, the pretreatment time is 120 seconds, the gold plating time is 60 seconds, and the stirring speed is 150 rpm. Among them, Table 1 below presents the experimental results of each treatment parameter combination.
綜上所述，本發明的信號傳輸元件，透過本體具有由生物可降解材料形成的多個層體，且透過所述層體中的訊號感應部及訊號傳輸部分別感應與發送對應的血管訊號，可在病人術後的特定期間內持續監測目標血管；並在特定期間後，透過訊號傳輸元件在該病人體內被降解，而不需再進一步開刀取出，可避免再次手術的風險。另，透過多個突出構造設置於對應所監測之目標血管的位置，特別是藉由多個突出構造與目標血管的接觸，可強化訊號感應部於感應血流資訊的訊號強度。另，透過多個金屬構造的訊號傳輸段的工作頻率為相同，可強化該工作頻率的訊號傳輸強度；或，透過多個金屬構造的訊號傳輸段的工作頻率為不同，可提升訊號傳輸頻率的廣度。另，透過將構成金屬構造的鎂線鍍金，可降低反射損失，具有較低阻抗，提升輻射效率並降低阻抗損失。另，透過本發明所提出特定的鍍金條件，可獲得低 電阻、高附著力的訊號傳輸段。 To sum up, the signal transmission element of the present invention has a plurality of layers made of biodegradable materials through the body, and the signal sensing part and the signal transmission part in the layer respectively sense and send corresponding blood vessel signals. , the target blood vessel can be continuously monitored during a specific period after the patient's surgery; and after a specific period, the signal transmission element is degraded in the patient's body without the need for further surgery to remove it, thus avoiding the risk of re-operation. In addition, by disposing multiple protruding structures at positions corresponding to the target blood vessels to be monitored, especially by contacting the multiple protruding structures with the target blood vessels, the signal strength of the signal sensing portion in sensing blood flow information can be enhanced. In addition, the operating frequency of the signal transmission sections through multiple metal structures is the same, which can enhance the signal transmission strength of the operating frequency; or, the operating frequencies of the signal transmission sections through multiple metal structures are different, which can enhance the signal transmission frequency. Breadth. In addition, by plating the magnesium wires that make up the metal structure with gold, reflection losses can be reduced, resulting in lower impedance, improving radiation efficiency and reducing impedance losses. In addition, through the specific gold plating conditions proposed by the present invention, low Resistive, high adhesion signal transmission section.
雖然本發明已利用上述較佳實施例揭示，然其並非用以限定本發明，任何熟習此技藝者在不脫離本發明之精神和範圍之內，相對上述實施例進行各種更動與修改仍屬本發明所保護之技術範疇，因此本發明之保護範圍當包含後附之申請專利範圍所記載的文義及均等範圍內之所有變更。 Although the present invention has been disclosed using the above-mentioned preferred embodiments, they are not intended to limit the invention. Anyone skilled in the art can make various changes and modifications to the above-described embodiments without departing from the spirit and scope of the invention. The technical scope protected by the invention, therefore, the protection scope of the invention shall include all changes within the literal and equivalent scope described in the appended patent application scope.
1:本體 1: Ontology
11:頭部 11:Head
12:延伸部 12:Extension part
3:突出構造 3: Prominent structure
L11:長度 L 11 :Length
W11,W12:寬度 W 11 , W 12 : Width
T11,T12:厚度 T 11 , T 12 : Thickness
STP:訊號傳輸部 STP: Signal Transmission Department
SSP:訊號感應部 SSP: Signal Sensing Part
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|---|---|---|---|---|
| US20030082105A1 (en) * | 2001-06-04 | 2003-05-01 | Alan Fischman | Methods and devices for detection and therapy of atheromatous plaque |
| US20160331312A1 (en) * | 2013-01-24 | 2016-11-17 | GraftWorx, LLC | Method and apparatus for measuring flow through a lumen |
| TW201719466A (en) * | 2015-07-24 | 2017-06-01 | 壯生和壯生視覺關懷公司 | Biomedical devices for biometric based information communication |
| CN110613449A (en) * | 2019-09-23 | 2019-12-27 | 清华大学 | Degradable flexible blood vessel detection device and system |
| US11006845B2 (en) * | 2016-07-12 | 2021-05-18 | Graftworx, Inc. | System and method for measuring blood flow parameters in a blood vessel having an endovascular prosthesis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030082105A1 (en) * | 2001-06-04 | 2003-05-01 | Alan Fischman | Methods and devices for detection and therapy of atheromatous plaque |
| US20160331312A1 (en) * | 2013-01-24 | 2016-11-17 | GraftWorx, LLC | Method and apparatus for measuring flow through a lumen |
| TW201719466A (en) * | 2015-07-24 | 2017-06-01 | 壯生和壯生視覺關懷公司 | Biomedical devices for biometric based information communication |
| US11006845B2 (en) * | 2016-07-12 | 2021-05-18 | Graftworx, Inc. | System and method for measuring blood flow parameters in a blood vessel having an endovascular prosthesis |
| CN110613449A (en) * | 2019-09-23 | 2019-12-27 | 清华大学 | Degradable flexible blood vessel detection device and system |
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