TWI552717B - An organism paracentesis device - Google Patents
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本發明是關於一種生物組織穿刺裝置，尤指一種利用雙針管配合雙針頭的方式，於體內以其中一針頭進行採集檢體之同時，另一針頭可於穿刺入被取樣組織表面前以及抽出於被取樣組織後且脫離體表之前特續進行一藥劑之注射，使採樣檢體之針頭於抽離出體表之過程中不會將帶菌之檢體於體內進一步擴散感染其他正常組織。 The invention relates to a biological tissue puncture device, in particular to a method of using a double needle tube and a double needle to collect a sample in one body of the needle while the other needle can be inserted into the surface of the sampled tissue and extracted. After being sampled and separated from the body surface, an injection of a drug is continuously performed, so that the needle of the sampled sample does not further spread the infected sample in the body to infect other normal tissues during the process of withdrawing from the body surface.
當今醫學上針對腫瘤或癌症的確定診斷必須有病理組織或是細胞學檢查，以判斷病人目前的狀況程度適不適合手術治療，而在施行化學治療或電腦刀之前，均必須接受細針穿刺取得病理檢體組織，進一步進行病理組織切片或病理檢體的細菌培養分析，而導引細針穿刺的方式一般以腹部超音波下即可，但是如果腫瘤在超音波下偵測不易，則以電腦斷層檢查來導引細針穿刺。 Today's medical diagnosis of tumors or cancer must have pathological or cytological examinations to determine the current state of the patient's condition is not suitable for surgical treatment, and before the implementation of chemotherapy or computer knives, must receive fine needle aspiration to obtain pathology The specimen tissue is further analyzed by bacterial culture of pathological tissue sections or pathological specimens, and the method of guiding fine needle aspiration is generally performed under abdominal ultrasound, but if the tumor is not easily detected under ultrasound, computerized tomography is performed. Check to guide the fine needle puncture.
以細針抽吸細胞學來判讀腫瘤之良惡性比起切片更為困難，所以一般病理醫師的經驗決定了是否適於使用細針抽吸細胞學檢查的方法來為病人診斷。當超音波發現有可疑之腫塊，需進一步再安排細針抽吸腫瘤細胞來進行細胞學檢查，以鑑別良性及惡性腫瘤。目前，經細針穿刺之細胞學檢查是診斷甲狀腺癌最有效且最準確的檢查方法。一般文獻上之報告使用細針抽吸細胞學檢查腫瘤其判斷良惡性之敏感度約為80%而特異性為100%。其缺點是 不能分別原位癌或是侵襲癌，所以目前細針抽吸細胞學檢查的使用多半應用在篩檢病人或是偵測轉移病灶等方面。 It is more difficult to interpret the benign and malignant tumors by fine needle aspiration cytology than the sectioning, so the general pathologist's experience determines whether it is suitable for the diagnosis of patients using fine needle aspiration cytology. When a suspicious mass is found in the ultrasound, further fine needle aspiration of the tumor cells is required for cytological examination to identify benign and malignant tumors. At present, cytological examination by fine needle aspiration is the most effective and accurate method for diagnosing thyroid cancer. The general literature reports the use of fine needle aspiration cytology to examine tumors with a sensitivity of about 80% and a specificity of 100%. The disadvantage is Can not be in situ cancer or invasive cancer, so the current use of fine needle aspiration cytology is mostly used in screening patients or detecting metastatic lesions.
然而，目前以細針抽吸癌症腫瘤細胞之採集檢體作業方式，僅停留在一般細針內持續保持負壓之大原則，以直接穿刺進入被取樣組織中並迅速擷取其檢體後隨即拔出細針，但是在此採集檢體的過程中均無任何額外的防護措施與裝置，以進一步杜絕抽取該細針時所造成被取樣組織之檢體洩漏擴散至周圍正常組織，導致被取樣組織週緣之正常組織具有遭到病毒污染而擴大其感染範圍之機率，進一步增加癌症病菌轉移之風險。 However, at present, the method of collecting specimens for sucking cancer tumor cells by fine needles only stays in the general fine needle to maintain the principle of negative pressure, so as to directly puncture into the sampled tissue and quickly take the specimen and then immediately The fine needle is pulled out, but there is no additional protective measure and device during the process of collecting the sample, so as to further prevent the sample of the sampled tissue from leaking and spreading to the surrounding normal tissue when the fine needle is taken, resulting in being sampled. The normal tissue around the tissue has the chance to be infected with the virus and expand its infection range, further increasing the risk of cancer pathogen transfer.
以肝腫瘤(肝癌)為例，為了詳細診斷肝腫瘤常以肝穿刺的方式獲取肝腫瘤細胞的病理組織，而進一步診斷確立後做正確的治療，然而，穿刺的方式也有可能使癌細胞經由穿刺的行經路徑方向而轉移，雖說機率不高有但也是具有相當程度的發生的機率。有鑑於此，本發明以一種生物組織穿刺裝置以降低於抽取被取樣組織之檢體樣本之過程所造成周邊正常組織之感染風險，進而提供醫界另一種低風險性穿刺取樣檢體之選擇。 Taking liver tumors (liver cancer) as an example, in order to diagnose liver tumors in detail, the pathological tissues of liver tumor cells are often obtained by liver puncture, and further diagnosis is performed after correct diagnosis. However, the way of puncture may also cause cancer cells to pass through the puncture. The direction of the route is shifted, although the probability is not high, but it also has a considerable probability of occurrence. In view of the above, the present invention provides a biological tissue puncturing device to reduce the risk of infection of surrounding normal tissues caused by the process of extracting the sample sample of the sampled tissue, thereby providing another selection of low-risk puncture sampling samples in the medical field.
本發明的主要目的是在於提供一種生物組織穿刺裝置，利用雙針管配合雙針頭的方式，於體內以一針管進行採集檢體之同時，另一針管可於穿刺入被取樣組織前以及抽出於被取樣組織後且脫離體表之前進行一藥劑之注射，進一步達到於擷取被取樣組織之檢體過程中防止感染 周圍正常組織之目的。 The main object of the present invention is to provide a biological tissue puncture device, which uses a double needle tube and a double needle to collect a sample in a needle tube in the body, and another needle tube can be inserted into the sampled tissue and extracted After the tissue is sampled and before the body surface is separated, an injection of a drug is performed to further prevent infection during the process of taking the sample of the sampled tissue. The purpose of surrounding normal tissue.
為達上述之目的，本發明一種生物組織穿刺裝置，其包括：一第一管體、以及一第二管體。該第一管體係包括：一注射管、一活塞、以及一第一針頭；其中，於該注射管內係可填充一藥劑。該第二管體係包括：一抽取端、一取樣管、以及一第二針頭；其中，該第二針頭係為雙針頭型態，其包括一擷取端以及一收集端。 To achieve the above object, a biological tissue puncturing device of the present invention comprises: a first tube body and a second tube body. The first tube system comprises: an injection tube, a piston, and a first needle; wherein the injection tube can be filled with a medicament. The second tube system comprises: a pumping end, a sampling tube, and a second needle; wherein the second needle is in the double needle type, and includes a picking end and a collecting end.
藉由該第二針頭位於該抽取端內之該收集端穿刺貫通於具有無菌真空且負壓之該取樣管內，透過該取樣管以壓力差的方式經由該第二針頭之該擷取端擷取被取樣組織之檢體。該注射管內之藥劑可於該第一針頭與第二針頭穿刺入被取樣組織前以及抽出於被取樣組織後且脫離體表之前進行注射，藉此達到避免病菌擴散感染甚至轉移之風險。 The collecting end of the second needle located in the extracting end penetrates through the sampling tube having a vacuum and a negative pressure, and passes through the sampling end of the second needle through the sampling tube. Take the specimen of the sampled tissue. The medicament in the syringe can be injected before the first needle and the second needle are punctured into the sampled tissue and after being withdrawn from the sampled tissue and before being separated from the body surface, thereby avoiding the risk of spreading the infection or even transferring the germ.
請參閱圖一以及圖二所示，圖一及圖二係分別為本發明生物組織穿刺裝置第一較佳實施例之剖面示意圖以及實施狀態示意圖。於本發明第一較佳實施例中，該生物組織穿刺裝置1係包括：一第一管體11、以及一第二管體12。該第一管體11係更包括：一注射管111、一活塞112、以及一第一針頭113。該第二管體12係更包括：一抽取端121、一取樣管122、以及一第二針頭123。該第一針頭113係與該注射管111內相連通，另外，該第二針頭123係為雙針頭型態，其包括一擷取端1231、以及一收集 端1232；其中，該收集端1232係位於該抽取端121之內，且透過該擷取端1231採集檢體樣本。於該注射管111內係可填充一藥劑3，且該藥劑3係可以是專門針對可殺死癌細胞但相對較不會傷害一般人體組織細胞之目前習知習用的殺癌細胞藥劑或癌細胞抑制劑其中之一。於本實施例中，該第一針頭113與該第二針頭123係為併排針，且該第一管體11之注射管111與該第二管體12之抽取端121係為一體成形。 Referring to FIG. 1 and FIG. 2, FIG. 1 and FIG. 2 are respectively a schematic cross-sectional view and a schematic diagram of an implementation state of a first preferred embodiment of the biological tissue puncture device of the present invention. In the first preferred embodiment of the present invention, the biological tissue puncturing device 1 includes a first tube body 11 and a second tube body 12. The first tube body 11 further includes an injection tube 111, a piston 112, and a first needle 113. The second tube 12 further includes an extraction end 121, a sampling tube 122, and a second needle 123. The first needle 113 is in communication with the inside of the injection tube 111. In addition, the second needle 123 is in a double needle type, which includes a capture end 1231 and a collection. The end 1232; the collecting end 1232 is located in the extracting end 121, and the sample sample is collected through the capturing end 1231. The medicament tube 3 can be filled with a medicament 3, and the medicament 3 can be a cancer cell killing agent or a cancer cell which is specifically used for killing cancer cells but relatively harming normal human tissue cells. One of the inhibitors. In the embodiment, the first needle 113 and the second needle 123 are side by side, and the injection tube 111 of the first tube 11 and the extraction end 121 of the second tube 12 are integrally formed.
該第二管體12之該取樣管122係為一獨立之管體，其包括有：一蓋體1221以及一容置空間1222。該蓋體1221係為具有高密合度之軟性橡膠材質所構成，並且覆蓋於該取樣管122上令該容置空間1222內形成無菌真空且負壓狀態。該取樣管122係可伸入結合於該第二管體12之該抽取端121內，經施以一定壓力後可藉由位於該抽取端121內之該第二針頭123的該收集端1232穿刺貫通該蓋體1221，使該收集端1232進入於該取樣管122之該容置空間1222內，透過該取樣管122以壓力差的方式經由該第二針頭123之該擷取端1231擷取一被取樣組織91(腫瘤或癌細胞群或病變細胞群)之檢體。該注射管111內之該藥劑3可於該第一針頭113與第二針頭123在穿刺入體表92(例如內臟表層或人體皮膚表層)但是在穿刺入該被取樣組織91表面前的期間、以及在抽出於該被取樣組織91表面後且脫離體表92(內臟表層或皮膚表層)前的期間，持續進行注射，因此可在體表92(例如內臟表層或人體皮膚表層)與被取樣組織91表面兩者之間形成一 注射有該藥劑3的區域，藉此達到避免因被取樣組織檢體94之病變細胞(例如癌細胞)或是該被取樣組織91因第二針頭123之該擷取端1231上所沾染的病變細胞、或是因為取樣穿刺所造成之傷口洩漏病變細胞擴散感染至周邊正常組織93，而有造成癌細胞轉移至其他臟器之風險。 The sampling tube 122 of the second tube body 12 is a separate tube body, and includes a cover body 1221 and an accommodating space 1222. The cover body 1221 is made of a soft rubber material having a high degree of adhesion, and covers the sampling tube 122 to form a sterile vacuum and a negative pressure state in the accommodating space 1222. The sampling tube 122 can be inserted into the extraction end 121 of the second tube 12, and after being applied with a certain pressure, the sample can be pierced by the collecting end 1232 of the second needle 123 located in the extraction end 121. The collecting portion 1221 is inserted into the accommodating space 1222 of the sampling tube 122, and the sampling tube 122 is drawn through the sampling end 122 by the suction end 1231 of the second needle 123. A sample of the tissue 91 (tumor or cancer cell population or diseased cell population) sampled. The medicament 3 in the syringe 111 can be inserted into the body surface 92 (for example, the visceral surface layer or the human skin surface layer) before the first needle 113 and the second needle 123 are penetrated into the surface of the sampled tissue 91, And after the surface of the sampled tissue 91 is extracted and before being separated from the body surface 92 (the visceral surface layer or the skin surface layer), the injection is continued, so that the body surface 92 (for example, the visceral surface layer or the human skin surface layer) and the sampled tissue can be 91 surface forms a The area where the agent 3 is injected is thereby prevented from avoiding lesions contaminated by the sampled tissue 94 of the sampled tissue 94 (e.g., cancer cells) or the sampled tissue 91 due to the captured end 1231 of the second needle 123. The cells, or the wounds caused by the sampling puncture, spread and infect the surrounding normal tissues93, which may cause the cancer cells to transfer to other organs.
換句話說，本發明生物組織穿刺裝置第一較佳實施例中，該第一管體11之該第一針頭113係緊鄰靠於該第二管體12之該第二針頭123一側邊，於擷取該被取樣組織91內之檢體作業時，該第一針頭113以及該第二針頭123係同時穿刺於該體表92之內，且穿越該正常組織93後到達該被取樣組織91表面之前(尚未穿刺進入被取樣組織)，先行適量推擠該第一管體11之該活塞112藉以將該注射管111內所填充之該藥劑3透過該第一針頭113進行防護注射，以降低該第二針頭123之該擷取端1231於穿刺該被取樣組織91時所造成之病變細胞洩漏擴散至外圍正常組織93、或是在拔出抽離第二針頭123的過程中將第二針頭123之該擷取端1231外表面所沾染的病變細胞擴散至外圍正常組織93的機率，且由於該藥劑3之屬性係僅針對病變細胞或癌細胞以及細菌進行撲殺防護而相對較不會危害到正常細胞的存在，因此可大幅降低該第一針頭113與該第二針頭123穿刺入於該被取樣組織91取樣檢體時，可能會造成該被取樣組織91(腫瘤)內病變之細胞或癌細胞因穿刺造成洩漏感染至外圍該正常組織93所造成之風險。 In other words, in the first preferred embodiment of the biological tissue puncturing device of the present invention, the first needle 113 of the first tube body 11 is immediately adjacent to the side of the second needle 123 of the second tube body 12, When the sample operation in the sampled tissue 91 is taken, the first needle 113 and the second needle 123 are simultaneously punctured into the body surface 92, and pass through the normal tissue 93 to reach the sampled tissue 91. Before the surface (not yet punctured into the sampled tissue), the piston 112 of the first tube 11 is pushed in an appropriate amount to thereby prevent the medicament 3 filled in the syringe 111 from being injected through the first needle 113 to reduce the injection. The pumping end 1231 of the second needle 123 leaks the diseased cells caused by the puncture of the sampled tissue 91 to the peripheral normal tissue 93, or the second needle during the process of pulling out the second needle 123. The probability that the diseased cells contaminated on the outer surface of the capture end 1231 spread to the peripheral normal tissue 93, and since the property of the drug 3 is only for the protection of the diseased cells or cancer cells and the bacteria, the damage is relatively less harmful. Storage of normal cells Therefore, when the first needle 113 and the second needle 123 are punctured into the sampled sample of the sampled tissue 91, the cells or cancer cells in the sampled tissue 91 (tumor) may be caused by puncture. The risk of leakage of infection to the peripheral normal tissue 93.
等待該第一針頭113以及該第二針頭123進入於該被 取樣組織91內時，該注射管111內之該藥劑3遂即停止注射並以該第二針頭123之該擷取端1231進行該被取樣組織91(腫瘤)內病變細胞之採集作業，也就是經由該取樣管122利用壓力差的方式吸取該被取樣組織91(腫瘤)內之病變細胞並透過該第二針頭123之該擷取端1231進行擷取該被取樣組織91內之病變細胞組織，並由該收集端1232穿刺入該蓋體1221而進入於該取樣管122中之該容置空間1222進行一預設數量之被取樣組織檢體94(癌細胞或病變細胞)的蒐集動作。 Waiting for the first needle 113 and the second needle 123 to enter the When the tissue 91 is sampled, the drug 3 in the injection tube 111 stops the injection, and the collection end 1231 of the second needle 123 performs the collection of the diseased cells in the sampled tissue 91 (tumor), that is, The diseased cells in the sampled tissue 91 (tumor) are aspirated by the sampling tube 122 and the diseased cells in the sampled tissue 91 are extracted through the extraction end 1231 of the second needle 123. The receiving space 1222 is inserted into the cover 1221 and enters the accommodating space 1222 of the sampling tube 122 to perform a collection operation of a predetermined number of sampled tissue samples 94 (cancer cells or diseased cells).
緊接著，當該第一針頭113與該第二針頭123抽離出該被取樣組織91表面時，推擠該活塞112令該注射管111內持續注射該藥劑3，直到將該第一針頭113以及該第二針頭123由原穿刺之路徑抽離退回該體表92之外後，隨即停止推擠該活塞112令該注射管111內之該藥劑3停止注射，並將採集有被取樣組織檢體94之該取樣管122由該第二管體12之該抽取端121內取出，令該第二針頭123之該收集端1232抽離出該取樣管122之內。 Then, when the first needle 113 and the second needle 123 are pulled out of the surface of the sampled tissue 91, the piston 112 is pushed to continuously inject the medicament 3 into the syringe 111 until the first needle 113 is pressed. And after the second needle 123 is withdrawn from the original puncture path and returned to the body surface 92, the piston 112 is stopped to stop the injection of the medicament 3 in the injection tube 111, and the sampled tissue is collected. The sampling tube 122 of the body 94 is taken out from the extraction end 121 of the second tube 12, so that the collecting end 1232 of the second needle 123 is pulled out of the sampling tube 122.
如此一來，不但完成該被取樣組織檢體94之檢體採集作業，更藉由本發明生物組織穿刺裝置1達到避免該被取樣組織91於取樣後，該第一針頭113與第二針頭123於拔出體表92前之行經路徑中使該被取樣組織91內之病變細胞(癌細胞)由該被取樣組織91擴散感染至周邊正常組織93甚至轉移至其他器官之風險。 In this way, not only the sample collection operation of the sampled tissue sample 94 is completed, but also the biological tissue piercing device 1 of the present invention prevents the sampled tissue 91 from being sampled, and the first needle 113 and the second needle 123 are The path in the path before the body surface 92 is pulled out so that the diseased cells (cancer cells) in the sampled tissue 91 are diffusely infected from the sampled tissue 91 to the surrounding normal tissues 93 or even transferred to other organs.
請參閱圖三所示，為本發明生物組織穿刺裝置第一較佳實施例使用方法之步驟流程圖。本發明生物組織穿刺裝 置之使用方法，其中，於實施時係包括有下列步驟：(A)將該生物組織穿刺裝置之一第一管體之一注射管中填充預設劑量之一藥劑；(B)將該第一管體之一第一針頭以及一第二管體之一第二針頭同時伸入於體表內；(C)當該第一針頭與該第二針頭接近於一被取樣組織表面前時，推擠該第一針頭之一活塞令該注射管內之該藥劑先行注射；(D)當該第一針頭與該第二針頭穿刺進入於被取樣組織中時，該第一針頭隨即停止注射該藥劑；(E)將一取樣管結合於該第二管體之一抽取端內，藉由該第二針頭位於該抽取端內之一收集端穿刺該取樣管上之一蓋體，並貫通於該取樣管內具有無菌真空且負壓效果之一容置空間中，且透過壓力差的方式經由該第二針頭之一擷取端擷取該被取樣組織之病變細胞檢體；(F)當該第一針頭與該第二針頭抽離出該被取樣組織表面時，推擠該活塞令該注射管內持續注射該藥劑，直到將該第一針頭與該第二針頭抽離出體表之外時隨即停止推擠該活塞令該注射管內之該藥劑停止注射；以及(G)將擷取有該被取樣組織之病變細胞檢體的該取樣管由該第二管體之該抽取端內取出，使該第二針頭之該收集端抽離該取樣管之該蓋體。 Please refer to FIG. 3, which is a flow chart showing the steps of the method for using the first preferred embodiment of the biological tissue puncture device of the present invention. Biological tissue puncture device of the invention The method of using the method includes the following steps: (A) filling one of the first tubes of the biological tissue piercing device with a predetermined dose of the first dose; (B) the first a first needle of one of the tubes and a second needle of a second tube simultaneously project into the body surface; (C) when the first needle and the second needle are in front of a surface of the sampled tissue, Pushing the piston of the first needle to cause the medicament in the syringe to be injected first; (D) when the first needle and the second needle are punctured into the sampled tissue, the first needle stops the injection (E) a sample tube is coupled to one of the extraction ends of the second tube body, and the second needle is located at a collection end of the extraction end to pierce a cover body of the sampling tube and penetrates The sample tube has a sterile vacuum and one of the negative pressure effects is accommodated in the space, and the lesion cell sample of the sampled tissue is taken through the pick-up end of the second needle through a pressure difference; (F) When the first needle and the second needle are pulled out of the surface of the sampled tissue, the work is pushed Continuing to inject the medicament into the syringe until the first needle and the second needle are pulled out of the body surface and then stop pushing the piston to stop the injection of the medicament in the syringe; and (G) The sampling tube that takes the diseased cell sample having the sampled tissue is taken out from the extraction end of the second tube, and the collection end of the second needle is pulled away from the cover of the sampling tube.
以下所述之本發明其他較佳實施例中，因大部份的元件係相同或類似於前述實施例，故相同之元件與結構以下將不再贅述，且相同之元件將直接給予相同之名稱及編 號，並對於類似之元件則給予相同名稱但在原編號後另增加一英文字母以資區別且不予贅述，合先敘明。 In the other preferred embodiments of the present invention described below, since the components are the same or similar to the foregoing embodiments, the same components and structures will not be described below, and the same components will be directly given the same names. And editing No., and for similar components, the same name is given, but an additional letter is added after the original number to distinguish it and not to repeat it.
請參閱圖四所示，為本發明生物組織穿刺裝置第二較佳實施例之部分放大示意圖。本發明之第二較佳實施例的生物組織穿刺裝置與圖一、圖二所述之第一較佳實施例之不同點在於，該第一針頭113之一外表面1131上設有貫通該第一針頭113之一管內壁1132的複數個側孔1133以提供注射該藥劑3。也就是說，透過該第一針頭113上所設之複數個側孔1133於注射該藥劑3時可進一步加大防護圍堵病變細胞擴散的空間，更能保障降低該第二針頭123之該擷取端1231於擷取該被取樣組織91之檢體時所造成之病變細胞洩漏擴散的機率。 Please refer to FIG. 4, which is a partially enlarged schematic view showing a second preferred embodiment of the biological tissue puncture device of the present invention. The biological tissue puncturing device of the second preferred embodiment of the present invention is different from the first preferred embodiment of FIG. 1 and FIG. 2 in that the outer surface 1131 of the first needle 113 is provided with the first A plurality of side holes 1133 of the inner wall 1132 of one of the needles 113 provide injection of the medicament 3. In other words, the plurality of side holes 1133 provided in the first needle 113 can further increase the space for protecting the diffusion of the diseased cells when the medicament 3 is injected, and the lowering of the second needle 123 can be ensured. The probability of leakage of the diseased cells caused by the end 1231 when the sample of the sampled tissue 91 is taken is diffused.
請參閱圖五、圖六所示，係分別為本發明生物組織穿刺裝置第三較佳實施例之部分剖面示意圖以及剖面示意圖。本發明之第三較佳實施例的生物組織穿刺裝置與圖四所述之第二較佳實施例之不同點在於，本發明之第三較佳實施例之該生物組織穿刺裝置1a，其中，該第一針頭113a與該第二針頭123a係為同心針，而該第一針頭113a與該第二針頭123a之針孔中心點位於同一中心軸5之上，且該第二針頭123a係位於該第一針頭113a之內而形成一針內有針(第一針頭113a內部還穿設有第二針頭123a)的結構。而該第二針頭123a之外表面1233a與該第一針頭113a之該管內壁1132a間隔一預設距離d以提供該藥劑3可自第一針頭113a內表面與第二針頭123a外表面之間的間隙注射流出。此外，於本發明該生物組織穿刺裝置1a 於採集檢體時，該第二針頭123a之該擷取端1231a可伸出於該第一針頭113a之外而進入於該被取樣組織檢體94之內進行癌細胞或病變細胞的蒐集動作。 Please refer to FIG. 5 and FIG. 6 , which are respectively a partial cross-sectional view and a cross-sectional view of a third preferred embodiment of the biological tissue puncture device of the present invention. The biological tissue puncturing device of the third preferred embodiment of the present invention is different from the second preferred embodiment of FIG. 4 in that the biological tissue puncturing device 1a of the third preferred embodiment of the present invention, wherein The first needle 113a and the second needle 123a are concentric needles, and the first needle 113a and the center point of the pinhole of the second needle 123a are located on the same central axis 5, and the second needle 123a is located at the same Inside the first needle 113a, a needle is formed in the needle (the second needle 113a is also provided with the second needle 123a). The outer surface 1233a of the second needle 123a is spaced apart from the inner wall 1132a of the first needle 113a by a predetermined distance d to provide the medicament 3 from the inner surface of the first needle 113a and the outer surface of the second needle 123a. The gap is injected and flows out. Furthermore, the biological tissue puncturing device 1a of the present invention When the sample is collected, the capturing end 1231a of the second needle 123a can protrude outside the first needle 113a and enter the sampled tissue 94 to collect cancer cells or diseased cells.
進一步說，本發明之第三較佳實施例之該生物組織穿刺裝置1a，其中，該第二管體12a係可伸入位於該活塞112a中央之一中空處1121a內，並與該活塞112a一併設置於該第一管體11a之內。該第二管體12a之取樣管122a係為一獨立之管體，其包括有：一蓋體1221a、一容置空間1222a以及一塞體1223a。該蓋體1221a係為具有高密合度之軟性橡膠材質所構成，並且覆蓋於該取樣管122a上令該容置空間1222a內形成無菌且負壓狀態。並且，於本實施例中，該第二管體12a之該取樣管122a內係可預先填充適量之習知用於保存所採集病變細胞的一培養液8。由於該活塞112a係為一端貫通(以供置入取樣管122a)且相對另一端係為軟性之一活塞頭1122a型態的中空管體，可使該第二管體12a之該取樣管122a以及所連接之該第二針頭123a伸入於該活塞112a之該中空處1121a之內。 Further, the biological tissue puncturing device 1a according to the third preferred embodiment of the present invention, wherein the second tubular body 12a is extendable into a hollow portion 1121a of the center of the piston 112a and is associated with the piston 112a. And disposed inside the first pipe body 11a. The sampling tube 122a of the second tube body 12a is a separate tube body, and includes a cover body 1221a, an accommodating space 1222a, and a plug body 1223a. The cover body 1221a is made of a soft rubber material having a high degree of adhesion, and covers the sampling tube 122a to form a sterile and negative pressure state in the accommodation space 1222a. Moreover, in the present embodiment, the sampling tube 122a of the second tube body 12a may be prefilled with an appropriate amount of a culture solution 8 conventionally used for preserving the collected diseased cells. Since the piston 112a is a hollow tube body having one end penetrating (for inserting into the sampling tube 122a) and being softer than the other end, the sampling tube 122a of the second tube body 12a can be used. And the connected second needle 123a protrudes into the hollow portion 1121a of the piston 112a.
進行檢體取樣動作時，首先將該第一管體11a之一第一針頭113a前端刺伸入於體表92內。當該第一針頭113a逐漸接近於該被取樣組織91但尚未到達被取樣組織91表面的期間，推擠該第一針頭113a之該活塞112a令該注射管111a內之該藥劑3先行注射，可因此在體表92(例如內臟表層或人體皮膚表層)與被取樣組織91表面兩者之間形成一注射有該藥劑3的區域95。直到第一針頭113a 的前端到達或即將到達被取樣組織91表面時，緊接著，推擠該第二管體12a將該取樣管122a所連接之該第二針頭123a前端之該擷取端1231a經由第一針頭113a之內部凸伸出，並同時將該第一針頭113a內之該藥劑3由該第一針頭113a上所設之複數個側孔1133a透過該第二針頭123a的擠壓過程中將該第一針頭113a內之該藥劑3由該些側孔1133a中擠出，進一步將該第二針頭123a之該擷取端1231a伸出於該第一針頭113a之外，並穿刺進入於被取樣組織91中(但此時第一針頭113a前端仍停留在被取樣組織91外表面不會刺入)。藉由該第二針頭123a的尾端(也就是收集端)穿刺貫通該蓋體1221a而凸伸入於該取樣管122a之該容置空間1222a內，透過該取樣管122a內部之負壓狀態，以壓力差的方式經由該第二針頭123a之該擷取端1231a吸取、擷取一被取樣組織91(腫瘤或癌細胞群或病變細胞群)之病變細胞檢體進入取樣管122a內部之容置空間1222a內並浸泡於培養液8中，達到完成檢體蒐集癌細胞或病變細胞的動作。接著，將擷取有該被取樣組織91之檢體的該取樣管122a抽離出該活塞112a之該中空處1121a，接著，適量地拔取活塞112a使得第二針頭123a連同活塞112a一起被拔取，直到第二針頭123a的擷取端1231a再度縮回第一針頭113a前端內部，之後，再將該第一管體11a與該第一針頭113a逐漸抽離被取樣組織91的表面，此時可以選擇性地再次將該第一針頭113a內之該藥劑3由該些側孔1133a中少量地擠出(以便確保該藥劑3之區域95的殺癌細胞效果)，直到第一針頭 113a被完全抽離體表92外為止。當然，於本實施例中所述之在將第一管體11a與該第一針頭113a逐漸抽離被取樣組織91的表面但尚未離開體表92外的過程中，其實也可以不需再次注射該藥劑3，因為於本實施例中，此時該第二針頭123a的擷取端1231a是完全內縮於第一針頭113a內且浸泡於第一針頭113a內所原有的藥劑3中，所以不會有將第二針頭123a的擷取端1231a外表面所沾染之病變細胞擴散到其他部位之虞。 When the sample sampling operation is performed, first, the tip end of the first needle 113a of the first tube body 11a is inserted into the body surface 92. While the first needle 113a is gradually approaching the sampled tissue 91 but has not yet reached the surface of the sampled tissue 91, the piston 112a pushing the first needle 113a causes the medicament 3 in the syringe 111a to be injected first. Thus, a region 95 in which the medicament 3 is injected is formed between the body surface 92 (e.g., the visceral surface layer or the human skin surface layer) and the surface of the sampled tissue 91. Until the first needle 113a When the front end reaches or is about to reach the surface of the sampled tissue 91, then the second tube 12a is pushed to the leading end 1231a of the second needle 123a to which the sampling tube 122a is connected via the first needle 113a. The first needle 113a is protruded during the extrusion process of the first needle 113a from the plurality of side holes 1133a of the first needle 113a through the second needle 123a. The medicament 3 is extruded from the side holes 1133a, and the picking end 1231a of the second needle 123a is further protruded outside the first needle 113a, and is punctured into the sampled tissue 91 (but At this time, the front end of the first needle 113a still stays on the outer surface of the sampled tissue 91 and does not penetrate. The tail end (ie, the collecting end) of the second needle 123a penetrates through the cover body 1221a and protrudes into the accommodating space 1222a of the sampling tube 122a, and passes through the negative pressure state inside the sampling tube 122a. A lesion cell sample of the sampled tissue 91 (tumor or cancer cell group or diseased cell population) is aspirated into the sample tube 122a via the extraction end 1231a of the second needle 123a in a pressure difference manner. The space 1222a is immersed in the culture solution 8, and the action of collecting the cancer cells or the diseased cells by the sample is completed. Next, the sampling tube 122a that has taken the sample of the sampled tissue 91 is pulled out of the hollow portion 1121a of the piston 112a, and then the piston 112a is extracted in an appropriate amount so that the second needle 123a is extracted together with the piston 112a. Until the capturing end 1231a of the second needle 123a is again retracted into the front end of the first needle 113a, the first tube 11a and the first needle 113a are gradually pulled away from the surface of the sampled tissue 91, and then the surface can be selected. The drug 3 in the first needle 113a is again squeezed out a small amount from the side holes 1133a (to ensure the cancer cell killing effect of the region 95 of the medicament 3) until the first needle 113a was completely removed from the body surface 92. Of course, in the process of gradually withdrawing the first tube 11a and the first needle 113a from the surface of the sampled tissue 91 but not leaving the body surface 92 in the present embodiment, it is not necessary to re-inject. In the present embodiment, the capturing end 1231a of the second needle 123a is completely retracted into the first needle 113a and immersed in the original medicament 3 in the first needle 113a. There is no possibility that the diseased cells contaminated on the outer surface of the extraction end 1231a of the second needle 123a are spread to other sites.
進一步說，本發明之第三較佳實施例之該生物組織穿刺裝置1a於實施時係包括有下列步驟：(1)將該生物組織穿刺裝置第三較佳實施例之一第一管體之一注射管中填充預設劑量之一藥劑，以及於一第二管體之一取樣管中填充預設劑量之一培養液；(2)該第二管體係伸入位於該第一管體內之一活塞的一中空處之內，且將該第一管體之一第一針頭伸入於體表內；(3)當該第一針頭接近於一被取樣組織表面前時，推擠該第一針頭之該活塞令該注射管內之該藥劑先行注射，可因此在體表(例如內臟表層或人體皮膚表層)與被取樣組織表面兩者之間形成一注射有該藥劑的區域；(4)推擠該第二管體將該取樣管所連接之該第二針頭前端之該擷取端經由第一針頭之內部凸伸出，並同時將該第一針頭內之該藥劑由該第一針頭上所設之複數個側孔透過該第二針頭的擠壓過程中將該第一針頭內之該藥劑由該些側孔中擠出； (5)將該第二針頭之該擷取端伸出於該第一針頭之外，並穿刺進入於被取樣組織中，此時第一針頭前端仍停留在被取樣組織外表面不會刺入；(6)藉由該第二針頭的尾端(也就是收集端)穿刺貫通該蓋體而凸伸入於該取樣管之該容置空間內，透過該取樣管部之負壓狀態，以壓力差的方式經由該第二針頭之該擷取端吸取、擷取一被取樣組織(腫瘤或癌細胞群或病變細胞群)之病變細胞檢體進入取樣管內部之容置空間內並浸泡於培養液中；以及(7)將擷取有該被取樣組織之檢體的該取樣管抽離出該活塞之該中空處，接著，適量地拔取活塞使得第二針頭連同活塞一起被拔取，直到第二針頭的擷取端再度縮回第一針頭前端內部，之後，再將該第一管體與該第一針頭抽離體表外。 Further, the biological tissue puncturing device 1a of the third preferred embodiment of the present invention comprises the following steps: (1) the first tube body of the third preferred embodiment of the biological tissue puncturing device Filling a syringe with a predetermined dose of a medicament, and filling a sample tube of a second tube with a predetermined dose of the culture solution; (2) extending the second tube system into the first tube body a hollow portion of a piston and extending a first needle of the first tubular body into the body surface; (3) pushing the first needle when it is close to a surface of the sampled tissue The piston of a needle causes the medicament in the syringe to be injected first, so that an area injected with the medicament is formed between the body surface (for example, the surface layer of the visceral surface or the surface layer of the human skin) and the surface of the sampled tissue; (4) Pushing the second tube body to project the capturing end of the front end of the second needle to which the sampling tube is attached, and simultaneously projecting the medicament in the first needle by the first a plurality of side holes provided on the needle are passed through the second needle during the extrusion process The medicament in the first needle is extruded from the side holes; (5) extending the grasping end of the second needle outside the first needle, and puncture into the sampled tissue, at which time the front end of the first needle remains on the outer surface of the sampled tissue and does not penetrate (6) the tail end of the second needle (that is, the collecting end) is pierced through the cover body and protrudes into the accommodating space of the sampling tube, and passes through the negative pressure state of the sampling tube portion to The method of the pressure difference sucks and takes a diseased cell sample of the sampled tissue (tumor or cancer cell group or the diseased cell group) into the accommodating space inside the sampling tube through the extraction end of the second needle and soaks in And (7) drawing the sampling tube of the sample from which the sampled tissue is taken out of the hollow portion of the piston, and then extracting the piston in an appropriate amount so that the second needle is extracted together with the piston until The pick-up end of the second needle is again retracted into the front end of the first needle, and then the first tube and the first needle are pulled out of the body.
綜上所述，本發明一種生物組織穿刺裝置1係包括：一第一管體11、以及一第二管體12。該第一管體11係包括：一注射管111、一活塞112、以及一第一針頭113；其中，於該注射管111內係可填充一藥劑3。。該第二管體12係包括：一抽取端121、一取樣管122、以及一第二針頭123；其中，該第二針頭123係為雙針頭型態，其包括：一擷取端1231以及一收集端1232。 In summary, the biological tissue puncturing device 1 of the present invention comprises: a first tubular body 11 and a second tubular body 12. The first tube body 11 includes an injection tube 111, a piston 112, and a first needle 113. The injection tube 111 can be filled with a medicament 3. . The second tube 12 includes a sampling end 121, a sampling tube 122, and a second needle 123. The second needle 123 is a double needle type, and includes: a capturing end 1231 and a Collection end 1232.
該第二管體12之該取樣管122係為一獨立之管體，其包括有：一蓋體1221以及一容置空間1222。該蓋體1221係為具有高密合度之軟性橡膠材質所構成，並且覆蓋於該取樣管122上令該容置空間1222內形成無菌真空且負壓 狀態。藉由該第二針頭123位於該抽取端121內之該收集端1232穿刺該取樣管122之該蓋體1221並貫通於具有無菌且負壓之該取樣管122之容置空間1222內，透過該取樣管122以壓力差的方式經由該第二針頭123之該擷取端1231採集位於一體表92內之一被取樣組織91的檢體。該注射管111內之該藥劑3可於該第一針頭113與第二針頭123之該擷取端1231穿刺入該被取樣組織91表面前以及抽離出於被取樣組織91後且脫離該體表92之前進行持續注射，藉此達到避免該被取樣組織91於擷取檢體後，該第一針頭113與第二針頭123於抽離出該體表92前之行經路徑中使該被取樣組織91內之病變細胞(癌細胞)洩漏擴散感染至周邊正常組織93甚至轉移至其他器官之風險。 The sampling tube 122 of the second tube body 12 is a separate tube body, and includes a cover body 1221 and an accommodating space 1222. The cover body 1221 is made of a soft rubber material having a high degree of adhesion, and covers the sampling tube 122 to form a sterile vacuum and a negative pressure in the accommodating space 1222. status. The cover 1221 of the sampling tube 122 is pierced by the collecting end 1232 of the second needle 123 in the extraction end 121 and penetrates into the accommodating space 1222 of the sampling tube 122 having a sterile and negative pressure. The sampling tube 122 collects the sample of the sampled tissue 91 located in the unitary table 92 via the extraction end 1231 of the second needle 123 in a pressure differential manner. The medicament 3 in the syringe 111 can be punctured into the surface of the sampled tissue 91 before the grasping end 1231 of the first needle 113 and the second needle 123 and after being withdrawn from the sampled tissue 91 and detached from the body The continuous injection is performed before the table 92, thereby avoiding the sampling of the sampled tissue 91 after the sample is taken, and the first needle 113 and the second needle 123 are sampled in the path before being drawn out of the body surface 92. The diseased cells (cancer cells) within the tissue 91 leak and spread the risk of infection to surrounding normal tissues 93 and even to other organs.
唯以上所述之實施例不應用於限制本發明之可應用範圍，本發明之保護範圍應以本發明之申請專利範圍內容所界定技術精神及其均等變化所含括之範圍為主者。即大凡依本發明申請專利範圍所做之均等變化及修飾，仍將不失本發明之要義所在，亦不脫離本發明之精神和範圍，故都應視為本發明的進一步實施狀況。 The above-mentioned embodiments are not intended to limit the scope of application of the present invention, and the scope of the present invention should be based on the technical spirit defined by the content of the patent application scope of the present invention and the scope thereof. It is to be understood that the scope of the present invention is not limited by the spirit and scope of the present invention, and should be considered as a further embodiment of the present invention.
1、1a‧‧‧生物組織穿刺裝置 1, 1a‧‧‧ biological tissue puncture device
11、11a‧‧‧第一管體 11, 11a‧‧‧ first body
111、111a‧‧‧注射管 111, 111a‧‧ ‧ injection tube
112、112a‧‧‧活塞 112, 112a‧‧‧Pistons
1121a‧‧‧中空處 1121a‧‧ hollow
1122a‧‧‧活塞頭 1122a‧‧‧ piston head
113、113a‧‧‧第一針頭 113, 113a‧‧‧ first needle
1131‧‧‧外表面 1131‧‧‧ outer surface
1132、1132a‧‧‧管內壁 1132, 1132a‧‧ ‧ inner wall
1133、1133a‧‧‧側孔 1133, 1133a‧‧‧ side holes
12、12a‧‧‧第二管體 12, 12a‧‧‧Second body
121‧‧‧抽取端 121‧‧‧ extracting end
122、122a‧‧‧取樣管 122, 122a‧‧‧Sampling tube
1221‧‧‧蓋體 1221‧‧‧ cover
1222、1222a‧‧‧容置空間 1222, 1222a‧‧‧ accommodating space
1223a‧‧‧塞體 1223a‧‧‧ body
123、123a‧‧‧第二針頭 123, 123a‧‧‧second needle
1231、1231a‧‧‧擷取端 1231, 1231a‧‧‧ capture end
1232‧‧‧收集端 1232‧‧‧ Collecting end
1233a‧‧‧外表面 1233a‧‧‧ outer surface
3‧‧‧藥劑 3‧‧‧ Pharmacy
5‧‧‧中心軸 5‧‧‧ center axis
8‧‧‧培養液 8‧‧‧ culture solution
91‧‧‧被取樣組織 91‧‧‧sampled organizations
92‧‧‧體表 92‧‧‧ body surface
93‧‧‧正常組織 93‧‧‧Normal organization
94‧‧‧檢體 94‧‧‧Check
95‧‧‧區域 95‧‧‧ Area
圖一係本發明生物組織穿刺裝置第一較佳實施例之剖面示意圖。 BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic cross-sectional view showing a first preferred embodiment of the biological tissue puncture device of the present invention.
圖二係本發明生物組織穿刺裝置第一較佳實施例之實施狀態示意圖。 Figure 2 is a schematic view showing the state of implementation of the first preferred embodiment of the biological tissue puncture device of the present invention.
圖三係本發明生物組織穿刺裝置第一較佳實施例使用方法之步驟流程圖。 Figure 3 is a flow chart showing the steps of the method of using the first preferred embodiment of the biological tissue puncture device of the present invention.
圖四係本發明生物組織穿刺裝置第二較佳實施例之部分放大示意圖。 Figure 4 is a partially enlarged schematic view showing a second preferred embodiment of the biological tissue puncture device of the present invention.
圖五係本發明生物組織穿刺裝置第三較佳實施例之部分剖面示意圖。 Figure 5 is a partial cross-sectional view showing a third preferred embodiment of the biological tissue puncture device of the present invention.
圖六係本發明生物組織穿刺裝置第三較佳實施例之剖面示意圖。 Figure 6 is a schematic cross-sectional view showing a third preferred embodiment of the biological tissue puncture device of the present invention.
1‧‧‧生物組織穿刺裝置 1‧‧‧ Biological tissue puncture device
11‧‧‧第一管體 11‧‧‧First tube
111‧‧‧注射管 111‧‧‧Injection tube
112‧‧‧活塞 112‧‧‧Piston
113‧‧‧第一針頭 113‧‧‧First needle
12‧‧‧第二管體 12‧‧‧Second body
121‧‧‧抽取端 121‧‧‧ extracting end
122‧‧‧取樣管 122‧‧‧Sampling tube
1221‧‧‧蓋體 1221‧‧‧ cover
1222‧‧‧容置空間 1222‧‧‧ accommodating space
123‧‧‧第二針頭 123‧‧‧second needle
1231‧‧‧擷取端 1231‧‧‧Selection
1232‧‧‧收集端 1232‧‧‧ Collecting end
3‧‧‧藥劑 3‧‧‧ Pharmacy
Claims (5)
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| TW101124772A TWI552717B (en) | 2012-07-10 | 2012-07-10 | An organism paracentesis device |
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| TW101124772A TWI552717B (en) | 2012-07-10 | 2012-07-10 | An organism paracentesis device |
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| TWI552717B true TWI552717B (en) | 2016-10-11 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030055373A1 (en) * | 2001-08-03 | 2003-03-20 | Stemsource Llc | Devices and methods for extraction of bone marrow |
| US20080167621A1 (en) * | 2005-05-16 | 2008-07-10 | Wagner Gary S | Multi-Barrel Syringe Having Integral Manifold |
| CN101282751A (en) * | 2005-07-18 | 2008-10-08 | 韦斯特制药服务公司 | Auto-injection syringe having vent device |
| WO2008153994A2 (en) * | 2007-06-11 | 2008-12-18 | Kieran Murphy | Method and kit for cyst aspiration and treatment |
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2012
- 2012-07-10 TW TW101124772A patent/TWI552717B/en not_active IP Right Cessation
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030055373A1 (en) * | 2001-08-03 | 2003-03-20 | Stemsource Llc | Devices and methods for extraction of bone marrow |
| US20080167621A1 (en) * | 2005-05-16 | 2008-07-10 | Wagner Gary S | Multi-Barrel Syringe Having Integral Manifold |
| CN101282751A (en) * | 2005-07-18 | 2008-10-08 | 韦斯特制药服务公司 | Auto-injection syringe having vent device |
| WO2008153994A2 (en) * | 2007-06-11 | 2008-12-18 | Kieran Murphy | Method and kit for cyst aspiration and treatment |
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| MM4A | Annulment or lapse of patent due to non-payment of fees |