Device for needle biopsy with integrated needle protection
39 claims: 32 independent, 7 dependent
- 1基端部と先端部とを有するハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置され、前記シース管腔内に配置された中空の針を含むとともに、前記針の基端側末端が接続された針ケース部材と、 前記針 内部に配置されたスタイレットと、 装置の操作性と作用性を向上させるために前記基端ハンドル部材と 前記先端ハンドル部材 上に配置された、円錐形グリップを含む人間工学設計の特徴点と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、 を備える針生検装置。
- 2基端部と先端部とを有するハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置され、前記シース管腔内に配置された中空の針を含むとともに、前記針の基端側末端が接続された針ケース部材と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、 を備える針生検装置。
- 3前記針保護 シャフト は、前記シース管腔の少なくとも1つの相補的係合部材と 係合 する、少なくとも1つの係合部材を含む、請求項2に記載の 針生検装置 。
- 4前記針保護 シャフト の少なくとも1つの係合部材は、前記針保護部材の先端部に設けられている、請求項3に記載の 針生検装置 。
- 5前記シース管腔の少なくとも1つの係合部材は、前記シース管腔の先端部に設けられている、請求項3に記載の 針生検装置 。
- 6前記基端ハンドル部材から針ケース部材を脱着させると、前記シース管腔の少なくとも1つの係合部材は、前記針保護 シャフト の少なくとも1つの相補的係合部材と 係合 し、前記針保護シャフトが前記針の先端部を覆うようにさせる、請求項3に記載の 針生検装置 。
- 7前記針は、前記針の内部に配置されたスタイレットを更に含む、請求項2に記載の 針生検装置 。
- 8基端部と 先端部とを含むハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置されているとともに、平坦リングと、汚れ除去部材と、前記シース管腔内に配置され、表面に複数の突起を持つ針と、を含み、前記針の基端側端部が接続された針ケース部材と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、を備え 、前記基端ハンドル部材の内部には前記針保護ハブが係合する係合部材が設けられている 針生検装置。
- 9前記針保護ハブは、前記針保護シャフトの基端部を覆ってモールドされている、請求項8に記載の 針生検装置 。
- 10前記係合部材は、前記基端ハンドル部材内の前記針保護 ハブ の係合を容易にする、請求項8に記載の 針生検装置 。
- 11前記係合部材はO型のリングである、請求項8に記載の 針生検装置 。
- 12前記針ケース部材を前記ハンドル部材の 前記基端部 の中へ挿入すると、前記針の汚れ除去部材が前記針保護ハブを前記O型のリングを通して前進させて 前記 針保護ハブを前記基端ハンドル部材に固定させる、請求項11に記載の 針生検装置 。
- 13前記複数の突起は前記針の長さに沿って分布している、請求項8に記載の 針生検装置 。
- 14前記複数の突起は前記針の長さ方向に一定の割合で増加して配置されている、請求項8に記載の 針生検装置 。
- 15前記突起は前記針の少なくとも一部の長さに分布している、請求項8に記載の 針生検装置 。
- 16前記針ケース部材を 前記基端ハンドル部材から後退させると、 前記針の少なくとも1つの突起が、前記針保護ハブに係合する、請求項8に記載の 針生検装置 。
- 17前記針の突起が前記針保護ハブに係合した状態において、前記針ケース部材を前記基端ハンドル部材から更に後退させると、前記針保護ハブは、前記基端ハンドル部材の前記係合部材から外れ、 前記針保護シャフトが前記針の先端部を覆う、請求項16に記載の 針生検装置 。
- 18前記針は、前記針の内部に配置されたスタイレットを更に含む、請求項8に記載の 針生検装置 。
- 19前記針ケース部材との係合と開放を行う、 前記 基端ハンドル部材の 前記基端部 に配置されたリリース部材をさらに含む、請求項8に記載の 針生検装置 。
- 20前記リリース部材は、偏向可能ヒンジを組み込んだ押し込み部材を備える、請求項19に記載の 針生検装置 。
- 21前記押し込み部材が押し込まれると、 前記針ケース部材 が 前記基端ハンドル部材 から分離する、請求項20に記載の 針生検装置 。
- 22前記押し込み部材は、押し込まれると平坦リングを開放し、それによって、 前記針ケース部材 を実質的に横方向へ動かして前記針ケース部材を 前記基端ハンドル部材 から分離する、請求項21に記載の 針生検装置 。
- 23基端部と先端部とを有するハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置された針ケース部材と、 前記シース管腔内部 に配置され、エコー発生性と超音波可視性を高めるための複数の窪みを含 み、基端側端部において前記針ケース部材に接続された針と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、 を備える針生検装置。
- 24前記複数の窪みは前記針の長さに沿って分布している、請求項23に記載の 針生検装置 。
- 25前記複数の窪みは 前記 針の長さ方向に一定の割合で増加して配置されている、請求項23に記載の 針生検装置 。
- 26前記窪みの幾何形状は、円、凹面、円筒、螺旋、楕円、長方形、正方形、の少なくとも1つまたは複数から成る、請求項23に記載の 針生検装置 。
- 27前記針は、前記針の内部に配置されたスタイレットを更に含む、請求項23に記載の 針生検装置。
- 28基端部と先端部とを有するハンドル部材と、 前記ハンドル部材の基端部に配置された基端ハンドル部材と、 前記ハンドル部材の先端部に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配され、前記ハンドル部材の先端部から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置された針ケース部材と、 シース管腔内部に配置された針であって、基端側末端において前記針ケース部材に接続され、且つその上に複数の突起が配置され、更に、前記針の先端部の取り外しを可能とするジョイントを含む、針と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、 を備える針生検装置。
- 29基端部と先端部と停止部とを有するハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材であって、前記ハンドル部材の 前記基端部 に摺動可能に係合するように構成され、前記摺動可能な動きを制御するために、前記ハンドル部材の 前記基端部 に沿って埋め込まれた少なくとも1つの溝に係合するために、前記基端ハンドル部材の長手軸に沿う少なくとも1つのガイドレールを含む、基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材であって、前記ハンドル部材の 前記先端部 に摺動可能に係合するように構成され、前記摺動可能な動きを制御するために、前記ハンドル部材の 前記先端部 に沿って埋め込まれた少なくとも1つの溝に係合するために、前記先端ハンドル部材の長手軸に沿う少なくとも1つのガイドレールを含む、先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置された針ケース部材であって、前記シース管腔内に配置され、且つ基端側端部において前記針ケース部材に接続されている針を含む針ケース部材と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、を備える針生検装置。
- 30前記ハンドル部材の 前記停止部 は、前記基端ハンドル部材と 前記先端ハンドル部材 との間に配置され、前記基端ハンドル部材が前記先端ハンドル部材の中へ軸方向運動するのを防止し、さらには前記先端ハンドル部材が前記基端ハンドル部材の中へ軸方向運動するのを防止する、請求項29に記載の 針生検装置 。
- 31前記ハンドル部材の前記基端部に沿って埋め込まれた前記溝は、前記針が前記シース管腔の先端部を越えて延びる長さを表す、請求項29に記載の 針生検装置 。
- 32前記ハンドル部材の前記先端部に沿って埋め込まれた前記溝は、前記先端ハンドル部材が前記シース管腔を超えて伸びる長さを表す、請求項29に記載の 針生検装置 。
- 33前記針の少なくとも一部は、エコー発生性と超音波可視性を高めるための材料または設計の特徴点を含む、請求項29に記載の 針生検装置 。
- 34前記針は、前記針の内部に配置されたスタイレットを更に含む、請求項29に記載の 針生検装置 。
- 35基端部と先端部とを有するハンドル部材と、 前記ハンドル部材の 前記基端部 に配置された基端ハンドル部材と、 前記ハンドル部材の 前記先端部 に配置された先端ハンドル部材と、 前記ハンドル部材の内部に配置され、前記ハンドル部材の 前記先端部 から延びるシース管腔と、 前記基端ハンドル部材に着脱可能に配置された針ケース部材であって、前記シース管腔内に配置されているとともに近接側端部において前記針ケース部材に接続された針を含む、針ケース部材と、 前記先端ハンドル部材の先端部に部分的に配置された針係止部材と、 前記針ケース部材の先端部に部分的に配置され、 前記針の長手方向に沿って延在するとともに前記針が長手方向に沿って移動可能に挿通される針保護シャフトと、前記針保護シャフトの基端側末端に位置し、半径方向外側に向かって延在すると共に、前記基端ハンドル部材に係合する針保護ハブと、を 含む針保護部材と、を備える針生検装置。
- 36前記針係止部材は、 圧縮嵌合ハブと、 前記圧縮嵌合ハブ内に部分的に配置された圧縮ガスケットと、 前記圧縮ガスケット内に部分的に配置された円筒外筒と、 前記円筒外筒と 前記圧縮ガスケット 内に部分的に配置された針と、 を含む請求項35に記載の 針生検装置 。
- 37前記圧縮ガスケットは、変形可能な材料でできている、請求項36に記載の 針生検装置 。
- 38前記圧縮ガスケットは、前記針の外表面の少なくとも一部に接触すると、前記針の動きを防止する、請求項37に記載の 針生検装置 。
- 39前記圧縮嵌合ハブは、前記圧縮ガスケットを圧縮し、それにより 前記圧縮ガスケットを圧縮方向へ移動し、 前記円筒外筒を基端方向に移動し、 前記圧縮ガスケットを前記針との接触から開放する請求項38に記載の 針生検装置 。
Independent claims39
71 paragraphs, as filed
Cross-reference of related applications This application is a partial continuation of US Patent Application No. 12 / 243,367 filed on October 1, 2008, and US Provisional Patent Application No. 61 / 117,966 filed on November 26, 2008. It claims the interests of the issue. The entire contents of each are incorporated herein by reference.
Endoscopic ultrasonography has been used in the medical field for over 25 years. This method allows the clinician to scan, position and identify each layer of the patient's gastrointestinal tract and locate individual mucosal and submucosal layers. These identifications determine appropriate treatments for malignant tumors and various abnormalities.
Endoscopic ultrasonography consists of several steps. For example, a clinician gives a patient a sedative and inserts a probe into the patient's stomach or duodenum by upper gastrointestinal endoscopy. Then, the endoscope is inserted through the patient's mouth and advanced to the duodenum. Abnormalities are determined by imaging organs and tumors outside the gastrointestinal tract from various locations between the esophagus and duodenum. If something is wrong, the organ or mass is aspirated with a fine needle for biopsy. Organs such as the liver-prone pancreas and adrenal glands can be easily biopsied, similar to abnormal lymph nodes. The patient's gastrointestinal tract wall can also be imaged to determine the presence or absence of abnormalities. For example, if the patient's gastrointestinal wall is abnormally thick, inflammation or malignancy is suspected.
The quality of the image obtained by endoscopic ultrasonography is directly proportional to the level of frequency used. High-frequency ultrasound can produce high-quality images, but high-frequency ultrasound does not penetrate organ walls like low-frequency ultrasound. As a result, it is not possible to inspect nearby organs.
Mediastinal endoscopy is a widely used method for determining lymph node metastasis in the mediastinum. Mediastinoscopy is commonly used as a surgical prescription for outpatients and is considered to have a low incidence of serious side effects and a very high accuracy. Ultrasound-guided intrabronchial fine needle aspiration biopsy of the mediastinal lymph nodes is a tissue sampling of the mediastinal lymph nodes and is a less tissue-affecting option. Intrabronchial ultrasound has been widely adopted by pulmonologists and is about to replace mediastinoscopy in the near future. Intrabronchial ultrasound is easy for thoracic surgeons to master, and it is important to maintain their traditionally important role as specialists in the diagnosis and staging of thoracic malignancies.
When performing intrabronchial ultrasound, the clinician can perform needle aspiration from the lymph nodes using an orally inserted bronchoscope. In intrabronchial ultrasound, an endoscope equipped with an ultrasound processor and a small-diameter suction needle is guided through the patient's trachea. When in the proper position, the needle portion of the fine needle aspirator is advanced into the lymph nodes, the sample is aspirated, and the device is removed from the bronchoscope.
Endoscopic ultrasonography and endoscopic ultrasonography via fine needle aspiration are currently standard procedures in the fields of gastrointestinal endoscopy and bronchoscopy. These methods provide high sensitivity and specificity in controlling the development of diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, bronchial mass, and intraabdominal lymph nodes.
Endoscopic ultrasonography using fine needle aspiration requires a standard echo endoscopy luer port, a fine needle aspiration device attached to the action conduit. In a conventional device, a series of push handles and pull handles are used to control the axial movement of the catheter shaft of the device and the insertion depth of the needle. However, these devices have some drawbacks.
For example, the means for attaching the device to the echo endoscope is complicated. Current equipment utilizes a male mounting adapter, which must be screwed into the luer port of a female endoscope. Moreover, these devices are not ergonomically best used. Specifically, the clinician needs to operate several handles individually, and each handle must be locked with a cap screw to secure the device. All of these actions are quite lengthy tasks for the clinician. Moreover, the needles often bend or deform when removed from the device, leading to significant work delays and failures. In addition, multiple operations are required for one treatment, which prolongs the treatment. As a result, the clinician needs to reconfirm the position of the needle with respect to the desired suction location with each new operation.
Another difficulty with standard echo endoscopes is the lack of safe preventive maintenance design for needles. This is to prevent clinicians from being inadvertently stabbed by needles and to prevent witnessed medical staff from transmitting the patient's blood-borne pathogens. In the fine needle suction medical devices currently in use, in both ultrasonic endoscopy and intrabronchial ultrasound, when a sample is aspirated from the desired anatomical site, the fine needle suction catheter is echoed. It is removed from the endoscope and handed to a clinician for sample extraction and preparation. Clinicians are instructed to "resheat" (ie, pull the needle into the sheath of the catheter) before removing the needle from the echo endoscope. However, this is often not done. Then, while the fine needle suction device is removed and transferred, the needle tip of the device is exposed to the medical staff involved in the endoscopic ultrasound device and the intrabronchial ultrasound device, and is stabbed by the needle. There is a high risk of being contaminated or exposed to blood-borne pathogens.
Moreover, needles are routinely used in medical procedures, and biopsy is a major area of utilization of such devices. In endoscopic ultrasound (EUS) and endoscopic bronchoscopy (EBUS), the efficiency of ultrasound treatment depends on the ability to point the needle component to the desired sampling position. The smooth cylindrical surface of the needle is mirror-finished in the untreated state, and unfortunately it is very difficult to obtain an image using ultrasonography. To solve this problem, various techniques have been developed to improve the visibility of the needle in echo generation or ultrasound. Various techniques (sandblasting, surface etching and surface coating) have been used to "roughen" the surface of needle parts, but with insufficient results. This surface roughness results in scattering ultrasonic waves. Some of the problems with the above techniques relate to the angle of incidence (of sound waves from the ultrasonic generator) and the angle of reflection (of sound waves reflected towards the generator array). It is important that the method and design of the surface finish and surface deformation of the biopsy device needle can maximize the proportion of reflected waves detected by the ultrasonic array.
<p num="0012"> Therefore, it is necessary to improve the device used for endoscopic ultrasonography.</p>
<p num="0013"> According to one aspect of the invention, a device for needle biopsy is presented. This needle biopsy device is used to improve the maneuverability and operability of a handle member, a base end handle member, a tip handle member, a sheath lumen, a needle case member, a needle, a stylet, and the device. It has ergonomic features, including a conical grip.</p><p num="0014"> According to another aspect of the invention, one device for needle biopsy is presented. This needle biopsy device includes a handle member, a base end handle member, a tip handle member, a sheath lumen, a needle case member, a needle, a needle protection adapter, and a needle protection member.</p><p num="0015"> According to another aspect of the invention, one device for needle biopsy is presented. The needle biopsy device includes a handle member including an engageable member, a base end handle member, a tip handle member, a sheath lumen, a needle case member, a flat ring, a dirt removing member, and a plurality of surfaces. It includes a needle including a protrusion, a needle protection member, a needle protection hub, and a needle protection shaft.</p><p num="0016"> According to yet another aspect of the invention, one device for needle biopsy is presented. The needle biopsy device includes a handle member, a proximal handle member, a tip handle member, a sheath lumen, a needle case member, and a needle that includes a plurality of recesses for increasing echo-generating and ultrasonic visibility. And have.</p><p num="0017"> According to yet another aspect of the invention, one device for needle biopsy is presented. The needle biopsy device includes a handle member, a proximal handle member, a tip handle member, a sheath lumen, a needle case member, and a plurality of protrusions on the surface and a joint capable of removing the tip of the needle. It is equipped with a needle.</p><p num="0018"> According to another aspect of the invention, one device for needle biopsy is presented. The needle biopsy device is configured to slidably engage the handle member and at least one along a longitudinal axis that engages at least one groove embedded to control its slidable movement. Along a longitudinal axis configured to slidably engage a proximal handle member, including one guide rail, and engaging at least one groove embedded to control its slidable movement. It includes a tip handle member including at least one guide rail, a sheath lumen, a needle case member, and a needle.</p><p num="0019"> According to another aspect of the invention, one device for needle biopsy is presented. This needle biopsy device includes a handle member, a base end handle member, a tip handle member, a sheath lumen, a needle case member, a needle, and a needle locking member.</p><p num="0020"> The purpose and features of the invention, which are believed to be novel, will be described in detail within the appended claims. The present invention can be best understood by referring to the following description in conjunction with the accompanying drawings below, both in terms of configuration and method of operation, as well as further objectives and advantages.</p>
<figref num="1">It is sectional drawing of one Embodiment of the needle protection member by this invention.</figref><figref num="2">It is sectional drawing of one Embodiment of the needle protection member by this invention.</figref><figref num="3">It is sectional drawing of another embodiment of the needle protection member according to this invention.</figref><figref num="4">FIG. 5 is a perspective view of an embodiment of a needle protection adapter according to the present invention.</figref><figref num="5">It is a perspective view of one Embodiment of a lure adapter according to this invention.</figref><figref num="6">It is a perspective view of one Embodiment of a lure adapter according to this invention.</figref><figref num="7">It is sectional drawing of one Embodiment of the needle protection member by this invention.</figref><figref num="8">It is sectional drawing of one Embodiment of the needle protection member by this invention.</figref><figref num="9">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="10">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="11">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="12">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="13">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="14">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="15">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="16">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="17A">It is a perspective view of one Embodiment of the needle locking member according to this invention.</figref><figref num="17B">It is a perspective view of one Embodiment of the needle locking member according to this invention.</figref><figref num="18A">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="18B">It is a perspective view of one Embodiment of the needle protection member according to this invention.</figref><figref num="19">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="20A">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20B">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20C">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20D">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20E">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20F">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="20G">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="21">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="22">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="23A">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="23B">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="23C">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="23D">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="23E">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="24">It is a flow chart of ultrasonic wave by this invention.</figref><figref num="25">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="26">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="27">FIG. 5 is a perspective view of an embodiment of a needle according to the present invention.</figref><figref num="28">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="29">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="30">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="31">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="32A">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="32B">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="32C">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="32D">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="33">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="34">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="35">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="36">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="37">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="38A">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="38B">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="39A">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="39B">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="40">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="41">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="42">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="43">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="44">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref><figref num="45">It is a perspective view of one Embodiment of the needle biopsy apparatus according to this invention.</figref>
An exemplary embodiment of the present invention is discussed for a needle biopsy device that is coupled with an ultrasonic endoscope or ultrasonic bronchoscope to collect tissue, fluid, and cell samples from a patient. Various embodiments of the needle biopsy device are believed to include modular design. For example, the needle biopsy device may include a needle case member that is removed from the proximal handle member of the device for each path, that is, each time the clinician aspirates a sample from the lesion or abnormality. In addition, it has the potential to support the safety and protection of sharp needles when combined with an integrated catheter drive mechanism, needle forward / backward mechanism, and needle-incorporated device in one device. Embodiments of the design are also disclosed herein.
The present invention is believed to be applied to a variety of biopsy devices for taking samples from patients. It is also envisioned that the present invention will be used to collect body fluids, including those used in venous incisions, gastrointestinal tracts, intestines, urinary organs, and veterinary procedures. The present invention is not limited to this, but may be used for other needle biopsy applications including, but not limited to, liquid recovery, catheters, catheter introduction devices, spinal cord and epidural biopsies, apheresis, dialysis and the like.
In the discussion below, the term "base" refers to a structural part close to the clinician and the term "tip" refers to a structural part far from the clinician. According to the present invention, the term "clinician" refers to a person who collects a sample by inserting or removing a needle from a needle biopsy device and, in some cases, assisting it. An exemplary embodiment of the invention, shown in the accompanying drawings, is referred to in detail below.
1 and 2 are cross-sectional views of an embodiment of the needle protection member 100 used together with the luer portion 108 of the echo endoscope 110. The needle protection member 100 includes a needle protection shaft 102 and a needle protection hub 104. The length of the needle protection shaft 102 is, for example, 4 to 20 cm to prevent the clinician from accidentally being stabbed by the needle 114. The needle protection hub 104 is located at the proximal end of the needle protection member 100. In one embodiment, the needle protection hub 104 comprises at least one engaging member 116. At least one engaging member is, for example, a flange.
The needle protection member 100 is a compressible material such as polyurethane, polyetheramide or a copolymer thereof, silicone, neoprene rubber, polyvinyl chloride or a copolymer thereof, polyethylene or a derivative thereof, or other commercially available low-hardness polymer materials. Manufactured from. The manufacturing material is adapted to provide a compression fit between the needle protection member 100 and the luer portion 108 at the proximal end of the echo endoscope 110.
The needle protection member 100 covers the sheath lumen 106. The needle protection member 100 moves freely over the sheath lumen 106 at the proximal end of the echo endoscope 110. In one embodiment, the luer locking adapter of the needle biopsy device (not shown) is screwed onto the luer portion 108 so that the clinician attaches the needle biopsy device to the echo endoscope 110 when the needle protection member 100 Is fixed to the luer portion 108. When the luer locking adapter of the needle biopsy device is tightened to the luer portion 108, the needle protection member 100 is fixed in position.
The sheath lumen 106 is basically composed of rigid polymer extruded parts. The sheath lumen 106 may be made of, for example, a thermoplastic material. Examples of the thermoplastic material include, but are not limited to, polyurethane, polyamide and its derivative, ether blockamide copolymer, polyimide, polyethylene and its derivative, and polytetrafluoroethylene. The sheath lumen 106 may have a structure in which a thermoplastic material is spirally woven on the outside of a smooth inner core.
The sheath lumen 106 includes at least one engaging member 112, which is complementary to at least one engaging member 116 of the needle protection member 100. The engaging member 112 represents a change in the outer diameter of the tip of the sheath lumen 106. The outer diameter of the engaging member 112 may be, for example, about 0.002 inch to 0.050 inch and 0.005 inch to 0.020 inch.
In one embodiment of the invention, the clinician takes steps to prevent accidental needle sticks by pulling the sheath lumen 106 toward the proximal end. At the stage of pulling in, the engaging member 112 communicates with the engaging member 116. When the engaging member 112 communicates with the engaging member 116, the needle protection member 100 disengages from the luer portion 108 and covers the tip portion of the needle 114. The needle protection member 100 covers the needle 114 even when the needle 112 extends from the tip of the catheter sheath 106 to the maximum length.
FIG. 3 shows a cross-sectional view of another embodiment of the needle protection member 100. The needle protection member 100 is made of a compressible and deformable element 104 at the base end, and is compressed when inserted into the luer portion of an echo endoscope (not shown). The needle protection member 100 further includes a needle protection shaft 118 and a flat insert 120.
The needle protection shaft 118 is a rigid polymer such as polyurethane, polyamide and its derivatives, ether blockamide copolymer, polyimide, polyethylene and its derivatives, polytetrafluoroethylene and the like, or a metal base such as stainless steel and its derivatives. It may be manufactured by the elements of. In another embodiment, the needle protection shaft 118 is made of a material such as stainless steel, if the needle is damaged as a result of continuous use and passing while taking multiple samples. Allow the clinician to straighten the needle for reinsertion. Needle guard shaft 118 is flat in order to collateral requirements of compressibility and stiffness of insert 120 may be overmolded.
FIG. 4 is a perspective view of the needle protection adapter 200. The needle protection adapter 200 is attached to the proximal end side of the luer adapter 202 and the distal end side of the needle biopsy device 204. The needle protection adapter 200 includes a needle protection member 206, a needle protection shaft 208, an adapter member 210, and at least one engagement member 212.
The needle protection member 206 is overmolded with a thermoplastic material such as acrylonitrile butadiene styrene, polystyrene and its derivatives, polyetherketone, polyamide, polyethersulphon, polyurethane, ether blockamide copolymers, polyacetal, polycarbonate and its derivatives, etc. May be done. In one embodiment, the needle protection shaft 208 is made of a stainless steel pipe for subcutaneous injection, is rigid, and has the property of being able to straighten the needle if it bends during continuous use.
The adapter member 210 and the engaging member 212 assist in engaging the luer adapter 202, the needle protection adapter 200, and the needle biopsy device 204. The adapter member 210 and the engaging member 212 may have, for example, a thread groove configuration or a snap-fit type configuration.
In one embodiment, the needle protection adapter 200 is attached to the luer adapter 202 so that it cannot be removed. In another embodiment, the luer adapter 202 is connected to an echo endoscope (not shown) in a screwed type structure. The lure adapter 202 is a rigid or semi-rigid thermoplastic such as acrylonitrile butadiene styrene, polystyrene and its derivatives, polyetherketone, polyamides, polyethersulphon, polyurethanes, etherblockamide copolymers, polyacetals, and derivatives thereof. It may be an overmolded part made of a polymeric material.
With reference to FIGS. 5 and 6, a perspective view of an embodiment of the luer adapter 202 is shown. The luer adapter 202 may be attached to the needle protection adapter 200 with snap-fit connections 214, 216. The snap-fit connections 214,216 allow the clinician to remove the echo endoscope (not shown) from the luer adapter 202 relatively easily. For example, once the sample has been aspirated from the desired anatomical site, the echo endoscope can be removed from the tip of the luer adapter 202.
A cross-sectional view of an embodiment of the needle protection adapter 200 is shown with reference to FIGS. 7 and 8. The needle protection adapter 200 is composed of a needle protection member 206 extending from an intermediate portion to a tip portion of the needle protection adapter 200. The needle protection member 206 comprises a needle protection shaft 208 and at least one engaging member 222 on its inner diameter.
In one embodiment of the invention, when the clinician pulls the sheath lumen 218 towards the proximal end, the engaging member 222 communicates with the complementary engaging member 220 located at the tip of the sheath lumen 218. For example, when the engaging member 220 comes into contact with the engaging member 222 at the proximal end of the needle protection member 206, the sheath lumen 218 reaches the connection. At this stage, the needle 224 is fully protected within the needle protection shaft 208 so that the clinician can remove the needle protection adapter 200 from the luer adapter 202. In this way, the needle protection shaft 208 can cover the needle 224 protruding toward the tip even when the needle 224 extends from the tip of the needle protection member 206 to the maximum length.
9 to 12 show perspective views of the needle protection member 300 and the needle biopsy device 310. The needle protection member 300 includes a needle protection hub 302 and a needle protection shaft 304. Needle protection hubs are rigid or semi-rigid, such as, for example, acrylonitrile butadiene styrene, polystyrene and derivatives thereof, polyetherketone, polyamide, polyethersulfone, polyurethane, polyethylene, ether blockamide copolymers, polyacetal, polycarbonate and derivatives thereof, etc. It may be made of the thermoplastic material of.
The needle biopsy device 310 includes a needle case member 312, a base end handle member 314, a handle member 316, and a tip handle member 318. In the embodiment of the present invention, the needle protection member 300 is preliminarily incorporated in the tip end side of the needle case member 312. As the needle case member 312 advances into the base end handle member 314, the needle protection hub 302 and the needle protection shaft 304 are secured between the engaging member 320. For example, the needle protection hub 302 is substantially fixed between the engaging members 320 in the base end handle member 314 in a snap-fit configuration.
Next, referring to FIGS. 13 to 16, a perspective view of an embodiment of the needle protection hub 302 and the needle protection shaft 304 is shown. The needle protection hub 302 and the needle protection shaft 304 may be injection molded parts molded from a series of commercially available rigid or semi-rigid thermoplastic materials. These materials include, but are not limited to, acrylonitrile butadiene styrene, polystyrene and its derivatives, polyetherketone, polyamides, polyethersulphon, polyurethanes, etherblockamide copolymers, polyacetals, polycarbonates and their derivatives. .. In one embodiment, the needle protection hub 302 and the needle protection shaft 304 are essentially composed of a transparent or translucent material such as polystyrene, polycarbonate, styrene acrylonitrile and the like. Being transparent or translucent can give the clinician visual feedback of the position of the needle 324 with respect to the tip of the needle protection shaft 304.
In one embodiment of the invention, the needle 324 includes an engaging member 322 located at a specific distance from the tip of the needle 324. The position of the engaging member 322 along the needle 324 corresponds to the maximum penetration depth of the needle during sampling. The engaging member 322 may be, for example, a polymer extruded spacer. When the clinician retracts the needle 324 through the needle protection shaft 322, the needle protection hub 302 is a proximal handle member until at least one engaging member 322 engages the corresponding engaging member in the needle protection hub 302. It remains locked in 314. At this stage, if the clinician further increases the pulling force later, the needle protection hub 302 disengages from the engaging member 320 and is wrapped in a case as the needle 324 is pulled out of the proximal handle member 314, resulting in accidental. It is prevented from being stabbed by a needle.
17A and 17B show perspective views of embodiments of the needle locking member. In the embodiment of the present invention, the needle locking member is composed of a compression gasket 400, a compression fitting hub 410, and a cylindrical outer cylinder 412. The needle 402 is partially arranged in the compression gasket 400 and the cylindrical outer cylinder 412. A part of the compression gasket 400 is arranged inside the compression fitting hub 410, and a part of the cylindrical outer cylinder 412 is arranged inside the compression gasket 400. The compression gasket 400 may be made of, for example, silicone and other flexible deformable polymers or rubber materials that can be compressed and decompressed as desired.
In one embodiment, the compression gasket 400 may be in a compressed state 404 or an uncompressed state 405. Next, referring to FIG. 17A, in the compressed state 404, the compression gasket 400 is in contact with a part of the needle 402. This prevents the needle 402 from being pushed out or retracted out of the tip of the catheter sheath 406. In this state, the clinician engages the luer component of the use channel of the endoscope (not shown) with the adapter 408 and attaches the adapter 408 to the echo endoscope. Then, in FIG. 17B, the clinician rotates the compression mating hub 410 to connect the compression mating hub 410 onto the adapter 408. As a result of this rotational movement, the compression gasket 400 moves toward the tip. Due to this rotation, the cylindrical outer cylinder 412 also moves through the compression gasket 400 at the base end. At this stage, if the compression fitting hub 410 and the adapter 408 are fixed in position, the compression gasket 400 will not come into contact with the needle 402. The needle 402 is then free to move forward and backward to collect the desired sample.
18A and 18B show perspective views of embodiments of the needle protection mechanism used in the needle biopsy devices 500 and 510. The needle biopsy device 500 includes a needle case member 502, a base end handle member 504, and a handle member 506. The needle case member 502 includes a needle therein. The needle biopsy device 510 includes a base end handle member 512 and a handle member 516.
In one embodiment, the needle case member 502 is completely inserted into the proximal handle member 504 so that the needle extends out from the tip of the sheath lumen (not shown). In this regard, when the clinician obtains a tissue sample, the clinician retracts the proximal handle 504 to its maximum width to ensure that the needle fits into the tip of the sheath lumen. To support this process, the needle biopsy device 500 incorporates a first engaging member 508 at the proximal end of the proximal handle member 504 and a second engaging member 514 at the proximal end of the handle member 516. Incorporate a third engaging member 518. These engaging members are used to prevent the proximal handle member 504 from advancing unless a clinician applies force. This feature also provides tactile feedback to inform the clinician that the needle has been locked. That is, it can be seen that the engaging members 508, 514, 518 click into the position. A feature of this design is that clinicians do not have to rely solely on properly locking the locking slide ring before removing the sheath lumen 506. With the introduction of self-locking mechanisms such as engaging members 508, 514, 518, clinicians are not required to lock the locking slide ring, which is intended to increase the efficiency of the procedure. Furthermore, by keeping the locking ring locked at a specific position on the handle member 504, the needle insertion setting is maintained when the clinician continuously passes the needle for multiple tissue samplings. It will be possible to keep it.
FIG. 19 shows a perspective view of another embodiment of the needle biopsy apparatus 520. The needle biopsy device 520 includes an adapter 522, a proximal handle member 524, an ergonomically designed feature point 526, 528 installed on the proximal handle member 524 and the distal handle member (not shown), and a locking ring 532. And a needle 530. In one embodiment, if the needle biopsy device 520 is attached to an echo endoscope, the needle biopsy device 520 is not involved in catheter shaft adjustment.
The base end handle member 524 incorporates ergonomic design features 526, 528 to give the clinician a better feel for the needle biopsy device 520. The ergonomic features 526 and 528 are, for example, conical knobs and recesses suitable for the thumb and index finger. The locking ring 532 allows the clinician to lock the extension depth of the needle from the end of the sheath lumen of the device. The locking ring 532 can be moved toward the tip end or the base end direction, and the position can be locked by tightening.
Next, FIGS. 20A to 24 show perspective views of embodiments relating to needle design features. When the needle exhibits the maximum extension length, the features related to echo generation are embedded over the entire length of the tip portion. This function is achieved by removing the material from the surface of the needle, increasing the reflectance and increasing the reflection intensity of the signal. However, removing the material is thought to reduce performance from the point of view of needle pushing and diminish the ability to obtain the desired sample.
FIG. 20A shows a perspective view of an embodiment of the needle 600. The needle 600 includes a plurality of recesses 602. The recess 602 is an element such as, but not limited to, circular, concave, cylindrical, spiral, elliptical, rectangular, square, etc., and is in the form of a recess on the surface of the needle 600. The recess 602 may be spirally arranged around the tip of the needle. These depressions may extend to the very tip of the tip slope of the needle 600, or may end at a specific distance from the slope. The length of the tip of the needle 600 having such a recess is, for example, 1 to 20 cm. In another embodiment, this length is 5-10 cm. In FIGS. 20B and 20C, the recess 602 is the detail 604 of the concave surface. In FIGS. 20D and 20E, the recess 602 is the bottom edge 606 of the square. In FIGS. 20F and 20G, the recess 602 is a hemispherical bottom surface 608.
FIG. 21 shows a perspective view of another embodiment of the needle 610. The needle 610 is composed of an elliptical recess 612 around the tip. FIG. 22 shows a perspective view of an embodiment of needle 614 with a square recess. The recess 616 may extend to the very tip of the tip slope of the needle 614, or may end at a specific distance from the slope. Referring to FIGS. 23A and 23B, an embodiment of a needle 614 including a spiral recess 620 and a helical recess 622 is shown. In FIG. 23C, the recess 624 is a concave detail. In FIG. 23D, the recess 626 is the edge of the bottom of the square. In FIG. 23E, the recess 628 has a hemispherical bottom surface.
Next, FIG. 24 is a diagram of ultrasonic waves incident on the recess of the needle at angles α1 630 and β1 632. In one embodiment, the wave hits the bottom of the depression and is reflected upward at reflection angles α2 634 and β2 636, which are equal to the incident angles α1 630 and β1 632, respectively. This reflected wave is reflected for the second time on the side wall of the depression at the reflection angles of α3 638 and β3 640, respectively. This angle is equal to the incident angles α1 630 and β1 632, and the first reflection angles α2 634 and β2 636, respectively. In this way, the reflected wave is reflected by the ultrasonic converter at the same angle as the incident angle of the wave that was originally propagated and incident. In one embodiment, a recess designed to have a square end provides more efficient reflection of ultrasonic waves in this process.
Next, FIGS. 25 to 27 show perspective views of different design embodiments of the needle 700. The needle 700 includes a filter element 702, at least one protrusion 706, and a joint 708 and is housed inside a needle protection member 704.
In one embodiment of the invention, the joint 708 allows the clinician to remove the tip of the needle 700 from the body of the needle 700. The joint 708 is, for example, a wrap, snap fit or adhesive joint structure. The joint 708 must not impair the pushability or bending resistance of the needle 700 during sample extraction.
The filter element 702 acts as a membrane that captures the cells acquired during the aspiration process. In the post-suction procedure, the clinician removes the needle case member at the end of the handle of the needle biopsy device handle. When fully retracted, the pointed tip of the needle 700 is protected by the needle protection member 704. The clinician can remove the needle 700 at the joint 708 and safely insert the needle 700 into the vile for analysis. EUS or EBUS devices typically require a waiting time to remove the sample from the needle 700 before continuous needle insertion, but eliminating the sample preparation time in this way makes the fine needle suction process more efficient. Will be improved.
In FIGS. 28-45, various embodiments of a needle biopsy device with replaceable needle case members are shown. The needle biopsy apparatus 800 is shown in FIGS. 28 and 29. The needle biopsy device 800 includes a base end handle member 802, a base end internal handle member 804, a base end guide rail 805, a stop member 806, a tip guide rail 807, a tip internal handle member 808, a tip handle member 810, and a needle case member 812. It includes a stylet 814, a release member 816, a sheath lumen 818, a needle protection hub 820, a needle protection shaft 822, a ring engagement member 824, a proximal internal handle shaft 826, and a needle 828.
A method is provided in which the base end handle member 802 is used to slide the needle 828 along the base end internal handle member 804 to move forward and backward. For example, the proximal guide rail 805 at the tip of the proximal internal handle member 804 is a recessed groove that allows the needle 828 to move in and out of the tumor site.
A method is provided in which the tip handle member 810 is used to slide the sheath lumen 818 along the tip internal handle member 808 to adjust the protrusion depth with respect to the unfolded length of the needle 828.
In one embodiment, the needle case member 812 is pre-loaded into an integrated needle protection mechanism (not shown). When the clinician takes the cell sample, the needle case member 812 is unlocked from the proximal handle member 802 by pushing the release member 816. The release member 816 may be, for example, an external pushbutton hinge. By manipulating the release member 816, the clinician unlocks the needle case member 812 and pulls the needle from the device 800.
30 and 31 show perspective views of an embodiment of the proximal handle member 802. The base end handle member 802 includes a recess 830 for arranging the ring engaging member 824 and the base end guide rail 805. The proximal handle member 802 can freely slide back and forth along the proximal guide rail 805, allowing the clinician to advance and retract the needle during the procedure. The tip handle member (not shown) can slide freely back and forth along the tip guide rail to allow the clinician to adjust the depth of the sheath lumen 818 protruding from the end of the echo endoscope. It has become.
A perspective view of the handle member component is shown in FIGS. 32A to 32D. The tip handle member 810 comprises at least one hollow hole 834, a lock engagement hole 836 and a luer recess 838. In one embodiment, a threaded spacer is inserted into and secured in the hollow hole 834. Fixing is performed, for example, by mechanical press fitting or the use of an adhesive.
The base end internal handle member 804 and the tip end internal handle member 808 are separated by a stop member 806. The stop member 806 acts as a divider for controlling the forward and backward movement of the handle member along the base end internal handle member 804 and the tip internal handle member 808. In one embodiment, the stop member 806 is fixed to the recess 840 of the base end member. The stop member 806 shall not interfere with the function of the tapered passage 842 and the flat hole 844 for needle replacement.
FIG. 33 shows a perspective view of an embodiment of the needle case member 812. The needle case member 812 includes a flat ring 813 and a stylet 814. The flat ring 813 works in conjunction with the release member 816. The function of the flat ring 813 will be described in more detail below.
FIG. 34 shows a cross-sectional view of an embodiment of the needle case member 812. The needle case member 812 includes a ring engaging member 824, a needle lure hub 840, an inner case 842, and a needle strain release member 844. In one embodiment, the inner case 842 incorporates a release member 816 (shown in FIG. 29) and a shelf for engaging and disengaging. A feature of this design is that it gives the clinician a smooth locking response when the needle case member is secured to the assembly of the release member 816. The needle lure hub 840 is fixed to the needle case member 812 by various fixing means such as adhesive bonding, welding, brazing, and soldering methods. The inner case 842 acts as a coupler for imposing the needle strain release member 844.
Next, with reference to FIGS. 35 to 37, a perspective view of an embodiment of the needle protection hub 820 for use with the needle case member 812 is shown. The needle protection hub 820 includes an engaging member 846. The engaging member 846 communicates with the protrusion 848 at the tip of the needle. When the needle is continuously pulled in, the most proximal projection 848 is mechanically locked there in coordination with the engaging member 846. At this stage, when the clinician retracted the needle case member from the proximal handle, the needle protection hub 820 remained locked to the protrusion 848, which contained the sharp needle tip slope in the case and the needle was removed from the patient. Later, protect the clinician.
The needle protection hub 820 is a rigid, deformable metal such as aluminum, stainless steel, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN) and its rigid derivatives, polyamides, polyethylene, polyurethane, and polycarbonate. , May be made from thermoplastics or thermosetting materials. In one embodiment, these materials have hardnesses in the range D35-120, more preferably Shore D80-110.
The engaging member 846 is, but is not limited to, polyurethane and its derivatives, polyetheramide block copolymers, polyamides, styrene-butadiene rubbers and / or alternative derivatives of styrene-based polymers, neoprene, and polyethylene and itss. It may be made from a series of low hardness thermoplastic or thermosetting materials such as derivatives. In one embodiment, these manufacturing materials have hardnesses in the shore A70-120 range, more preferably in the shore A70-90 range.
38A-39B show various diagrams of one embodiment of the release member 816. The release member 816 is a mechanism for attaching the needle case member to the base end handle member of the needle biopsy device. The release member 816 is, for example, a push button, and when the external force on the release member 816 is removed, the hinge member 850 is used to operate the release member 816 so that the release member 816 returns to a fixed position. The hinge member 850 is elastically deformable and provides the opening and closing of a "lock" when the needle case member is removed. In one embodiment, the release member 816 incorporates an external coupling housing 852 and a pushbutton 816 type mechanism. Figures 39A and 39B show the release member 816 in open and closed positions in a typical operating cycle.
In FIGS. 38A and 38B, the release member 816 and the outer bonding housing 852 are such that acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or a rigid derivative thereof, polyamide, polyethylene, polyurethane, polycarbonate and the like. A series of rigid bodies may be made from non-deformable thermoplastics or thermosetting materials. In one embodiment, these manufacturing materials have hardnesses in the range D35-120, more preferably Shore D80-110.
The hinge member 850 is a series of rigid thermoplastics or thermocurable, such as, for example, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or a rigid derivative thereof, polyamide, polyethylene, polyurethane, and polycarbonate. It may be manufactured from a material. In one embodiment, the material to be manufactured must be bendable and deformable without cracks, fatigue or cracks under the external forces that it receives during the typical "open and close" cycles of needle biopsy equipment.
40-42 show perspective views of some embodiments of the needle protection member 820 used in the needle biopsy apparatus. In one embodiment, the needle case member is pre-mounted on the needle protection hub 820 and the needle protection shaft 822. After that, the needle case member is inserted into the proximal end portion of the proximal end handle member with the release member 816. The needle case member is continuously inserted and the tapered portion of the needle protection hub 820 is seated on the ring engaging member 824. When further force is applied, the needle protection hub 820 is pushed forward, and the ring engaging member 824 is deformed and comes to rest. At this stage, the needle protection hub 820 is fixed in position and stuck. Further, the flat ring of the needle case member activates the release member 816 to exceed the "flat ring" on the outer surface of the coupler of the release member 816. In equilibrium, the release member 816 is fully stretched and the coupler is locked in that position.
The intended function of the release member 816 is to prevent the needle case member from coming off the base end handle member without exerting force on the release member 816. For example, when the sample is sucked from the desired location, the release member 816 is activated and the needle is pulled out. The needle is continuously pulled out, and the engagement member 848 on the most proximal side engages the needle protection hub 820. When the needle is pulled out further by applying further force, the radius on the base end side of the tapered portion comes into contact with the ring engaging member 824. The ring engaging member 840 elastically expands and the needle protection hub 820 traverses the ring engaging member 840. As a result, the needle case member is completely pulled out of the device, with the sharp tip of the needle protected from accidental puncture. In addition, additional samples can be obtained using the same or new needle case members. Once the needle case member is inserted and locked into the coupler, the needle subassembly becomes rotatable. It is also envisioned that needle rotation and forward and backward movements with short movement widths will provide the ability to extract tissue during tissue acquisition.
FIG. 43 shows a perspective view of one embodiment of the coupler 854. In one embodiment, the coupler 854 utilizes an O-ring to smoothly lock the needle case member to the release member mechanism. In another embodiment, the O-ring is removable and the needle case member can be utilized without such parts.
FIG. 44 shows a perspective view of an embodiment of the needle biopsy device. The base end side internal handle member 804 and the tip end side internal handle member 808 are provided for the use of the fixing adjustment mechanism, and the thumbscrew frictionally fixes the base end side internal handle member and the tip end side internal handle member to obtain the needle insertion depth. Lock both sheath lumen insertion depths respectively.
Next, referring to FIG. 45, a perspective view of an embodiment of the ring engaging member 856 incorporated as part of the proximal side internal handle member 804 is shown. In one embodiment, the ring engaging member 856 is located in a recessed circular slot in the proximal side internal handle member 804. When the proximal handle member 802 is advanced and retracted in the distal direction and the proximal direction, the proximal internal handle member 804 slides across the inflatable ring member 856 in the distal direction and the proximal direction of the internal member. At this time, the expandable ring member 856 applies a frictional resistance force between the proximal end side internal handle member 804 and the proximal end handle member 802. When the clinician releases the proximal handle member 802, the inflatable ring member 856 creates sufficient friction with the proximal internal handle member 804 and the proximal handle member 802 stays in that position. It is considered to be fixed to the base end side internal handle member 804. In this way, the clinician can stop the forward or backward movement of the proximal handle member 802 and keep the handle in its place.
The expandable ring member 856 includes, but is not limited to, polyurethanes and derivatives thereof, polyetheramide block copolymers, polyamides, styrene-butadiene rubbers and / or alternative derivatives of styrene-based polymers, neoprene, and polyethylene. It may be made from a series of low hardness thermoplastic or thermosetting materials such as derivatives thereof. In one embodiment, these manufacturing materials have hardnesses in the shore A70-120 range, more preferably in the shore A70-90 range. Such O-ring components are readily available from a range of companies, such as McMaster-Carr, for example.
It should be understood that various changes can be made to the embodiments disclosed herein. Therefore, the above description should not be construed in a restrictive manner, but should be construed as merely an example of various embodiments of the present invention. Those skilled in the art will be able to imagine other changes in the scope and spirit of the appended claims.
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Every citation, both ways
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| JP2004505688A | Cites | Japan |
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68 members in 7 offices
Priority claims19
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Numbers
- Publication
- 5774489
- Publication, DOCDB
- 5774489
- Publication, EPODOC
- JP5774489B
- Application
- 2011538671
- Application, DOCDB
- 2011538671
- Application, EPODOC
- JP20110538671
Titles2
- Japanese
- 統合的針保護を施した針生検装置
- English
- Needle biopsy device with integrated needle protection
Classification
- CPC, 9
- A61B10/04
- A61B10/0283
- A61B2017/00424
- A61B2017/00477
- A61B2017/3413
- A61B2090/0801
- A61B2090/3925
- A61B10/0266
- A61B2010/045
- IPC, 1
- A61B10 02
