TW202315591A - Vascular and aortic connectors with robotic delivery - Google Patents
Vascular and aortic connectors with robotic delivery Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
Abstract
Description
本發明大體而言關於血管連接器和主動脈連接器,特別是關於用於置放此類連接器的置放工具及方法。The present invention relates generally to vascular connectors and aortic connectors, and more particularly to deployment tools and methods for deploying such connectors.
循環系統包括主動脈和其他大口徑血管,以及較小口徑的血管和微血管。利用介入治療來替換或支撐患病或受損血管的可涉及使用合成移植物來維持或恢復受影響血管的通暢以灌注下游解剖結構。雖然知道疾病和其他症狀影響所有類型血管,但由於血流量及血壓透過主動脈泵送,這些影響主動脈的疾病和其他症狀可能更為嚴重,且更可能導致病患死亡。因此,以下討論的實例是在主動脈移植物的背景下構建的,但應當理解,本揭示的技術適用於患者脈管系統的其他部分。The circulatory system includes the aorta and other large-bore vessels, as well as smaller-bore vessels and capillaries. The use of interventional therapy to replace or brace a diseased or damaged vessel may involve the use of synthetic grafts to maintain or restore patency of the affected vessel to perfuse downstream anatomy. Although diseases and other conditions are known to affect all types of blood vessels, due to blood flow and pressure being pumped through the aorta, diseases and other conditions affecting the aorta may be more serious and more likely to result in death. Thus, the examples discussed below are constructed in the context of an aortic graft, but it should be understood that the techniques of the present disclosure are applicable to other parts of a patient's vasculature.
主動脈瘤是一種可影響主動脈任何部分的嚴重症狀。腹部的主動脈瘤被稱為腹部主動脈瘤或AAA;胸腔中的主動脈瘤被稱為胸主動脈瘤或TAA,而在胸腔中主動脈弓上的動脈瘤被稱為主動脈弓動脈瘤。主動脈瘤可由不同原因引起,例如未治療或嚴重的高血壓、吸煙、馬凡氏症候群(Marfan’s syndrome)等一般疾病及主動脈壁的退行性擴張(degenerative dilation)。胸主動脈瘤由主動脈壁鬆弛引起,導致局部擴張,並且是危及生命的病症。具有胸動脈瘤的病患通常直到動脈瘤擴張都毫無症狀。最常見的病徵是疼痛和主動脈破裂。動脈瘤破裂可導致嚴重的內出血,迅速導致休克或死亡。Aortic aneurysm is a serious condition that can affect any part of the aorta. An aortic aneurysm in the abdomen is called an abdominal aortic aneurysm, or AAA; an aortic aneurysm in the chest cavity is called a thoracic aortic aneurysm, or TAA, and an aneurysm in the chest cavity above the aortic arch is called an aortic arch aneurysm. Aortic aneurysms can be caused by different causes such as untreated or severe high blood pressure, smoking, general diseases such as Marfan’s syndrome, and degenerative dilation of the aortic wall. Thoracic aortic aneurysms are caused by relaxation of the aortic wall, resulting in localized dilation, and are a life-threatening condition. Patients with thoracic aneurysms are usually asymptomatic until the aneurysm expands. The most common symptoms are pain and aortic rupture. A ruptured aneurysm can cause severe internal bleeding that can quickly lead to shock or death.
急性剝離的病患典型伴隨疼痛,且由於主動脈壁破裂剝離的風險會影響主動脈瓣的完整性,且透過波及冠狀動脈的起點而影響心肌的灌注,因而被歸類為緊急情況。通常,延伸到主動脈弓或涉及主動脈弓之任何動脈的升主動脈剝離需要外科手術插入移植物以替換升主動脈的患病部分,並需要額外的移植物以重建來自存在於任何剝離或疾病處的主動脈分支的每條動脈血流。可藉由將連接器從插入外形擴展到置放外形以將移植物固定至血管來將移植物連接到管脈系統。該程序亦可能涉及插入額外的支架,該支架專用於提供從升主動脈到降主動脈遠端的管脈系統的血流。亦可用類似的方式治療影響患者脈管系統其他部分的症狀。Patients with acute dissection are typically painful and are classified as an emergency because the risk of aortic wall rupture and dissection could compromise the integrity of the aortic valve and affect myocardial perfusion by affecting the origin of the coronary arteries. Typically, dissection of the ascending aorta extending into or involving any artery of the aortic arch requires surgical insertion of a graft to replace the diseased portion of the ascending aorta and an additional graft to reconstruct the aorta from any dissection or disease present. Arterial blood flow in each branch of the artery. The graft can be connected to the vasculature by expanding the connector from the insertion configuration to the deployment configuration to secure the graft to the vessel. The procedure may also involve the insertion of an additional stent designed to provide blood flow from the ascending aorta to the vasculature distal to the descending aorta. Conditions affecting other parts of the patient's vasculature may also be treated in a similar manner.
複合型胸主動脈疾病包括急性A型剝離(AAD)和慢性A型剝離(CAD),以及波及或未波及升主動脈和降主動脈的主動脈弓動脈瘤。主動脈剝離是由於主動脈壁內層中的撕裂導致血液進入並分離血管壁的血管層。急性主動脈剝離被定義為在初始撕裂後的前2週內所確認者,而慢性剝離被定義為在大於2週時間所確認者。主動脈剝離依其位置和胸主動脈被波及的程度進行分類。史丹佛(Stanford)A型剝離影響升主動脈,並可擴及至弓部和降胸主動脈。史丹佛B型剝離並不影響升主動脈,而通常波及末端在左鎖骨下動脈起點的降胸主動脈。大約三分之二的主動脈剝離為史丹佛A型。Compound thoracic aortic disease includes acute A-dissection (AAD) and chronic A-dissection (CAD), as well as aortic arch aneurysms with or without involvement of the ascending and descending aorta. Aortic dissection is the result of a tear in the inner layer of the aortic wall that allows blood to enter and separate the vessel layers of the vessel wall. Acute aortic dissection was defined as those identified within the first 2 weeks after the initial tear, whereas chronic dissection was defined as those identified over a period greater than 2 weeks. Aortic dissections are classified according to their location and extent of involvement of the thoracic aorta. Stanford type A dissection affects the ascending aorta and can extend to the arch and descending thoracic aorta. Stanford type B dissection does not affect the ascending aorta but usually involves the descending thoracic aorta ending at the origin of the left subclavian artery. About two-thirds of aortic dissections are Stanford type A.
複合型胸主動脈疾病的治療通常需要長時間且複雜的開放性手術。在此類手術期間,病患通常被放置心肺分流(cardiopulmonary bypass)泵,並將心臟停止以允許主動脈可被夾緊和進行手術。雖然病患是在心肺分流情況下,但病患通常也會被冷卻至低體溫狀態。病患在手術中無法存活的風險與病患者在幫浦和低溫下的持續時間直接相關。Treatment of complex thoracic aortic disease usually requires lengthy and complex open surgery. During such procedures, the patient is usually placed on a cardiopulmonary bypass pump and the heart is stopped to allow the aorta to be clamped and operated on. Although the patient is on cardiopulmonary bypass, the patient is usually cooled to a hypothermic state. The risk of a patient not surviving the procedure is directly related to the duration of time the patient is on pump and hypothermia.
因此,期望提供用於置放動脈瘤修復用的主動脈連接器的工具及方法,以促進和加速它們的放置。類似地,亦希望提供在患者之管脈系統的其他部分中可用於置放連接器的工具和方法。更進一步地,希望提供可用作機器或機器人自動遞送程序之一部分的工具和方法。如在下列材料中將詳細描述的,本揭示滿足這些及其他目標。Accordingly, it would be desirable to provide tools and methods for placing aortic connectors for aneurysm repair to facilitate and expedite their placement. Similarly, it would also be desirable to provide tools and methods that can be used to place connectors in other parts of a patient's vasculature. Still further, it would be desirable to provide tools and methods that can be used as part of a machine or robotic automated delivery program. These and other objectives are met by the present disclosure, as will be described in detail in the following materials.
本揭示涉及血管連接器置放工具,其具有一殼體;一內護套,其從體殼向遠側延伸,其中內護套可相對於殼體旋轉;一浮動心軸;一連接器,其將浮動心軸耦合至內護套遠端,從而內護套能相對於浮動心軸旋轉;一血管連接器,其圍繞心軸同軸配置;一外護套,可伸縮地置放於內護套上,其中當外護套設置在血管連接器上時,外護套配置為束縛血管連接器呈一插入外形圍繞心軸;及一驅動器,設置於殼體內,其耦合至外護套的近端,並配置為將內護套的旋轉運動轉換成外護套的縱向運動。The present disclosure relates to a vascular connector delivery tool having a housing; an inner sheath extending distally from the body housing, wherein the inner sheath is rotatable relative to the housing; a floating mandrel; a connector, It couples the floating mandrel to the distal end of the inner sheath so that the inner sheath can rotate relative to the floating mandrel; a blood vessel connector is coaxially arranged around the mandrel; an outer sheath is telescopically placed in the inner sheath sleeve, wherein when the outer sheath is disposed on the blood vessel connector, the outer sheath is configured to constrain the blood vessel connector in an insertion configuration around the mandrel; and a driver is disposed in the housing and is coupled to the proximal end of the outer sheath end and is configured to convert rotational motion of the inner sheath into longitudinal motion of the outer sheath.
在一方面,驅動器可同軸地設置於內護套近端部分上並與內護套近端部分上的外螺紋接合。驅動器可沿著殼體中的導件行進,該導件允許縱向運動並抵抗旋轉運動。In one aspect, the driver can be coaxially disposed on the proximal portion of the inner sheath and engaged with external threads on the proximal portion of the inner sheath. The driver can travel along a guide in the housing that allows longitudinal movement and resists rotational movement.
在一方面,驅動器可配置為將內護套的一第一預定的旋轉量轉換成外護套的一第一已知的縱向運動量。第一已知的縱向運動量可露出血管連接器的遠端部分。進一步地,驅動器可配置為將內護套的一第二預定的旋轉量轉換成外護套的一第二已知的縱向運動量,且其中該第二已知的縱向運動量露出該血管連接器的近端部分。In one aspect, the driver can be configured to translate a first predetermined amount of rotation of the inner sheath into a first known amount of longitudinal movement of the outer sheath. The first known amount of longitudinal movement may expose the distal portion of the vascular connector. Further, the driver may be configured to convert a second predetermined amount of rotation of the inner sheath into a second known amount of longitudinal movement of the outer sheath, and wherein the second known amount of longitudinal movement exposes the vascular connector proximal part.
在一方面,內護套具有從該殼體近端延伸的一介面,該介面配置為旋轉該內護套。In one aspect, the inner sheath has an interface extending from the proximal end of the housing, the interface configured to rotate the inner sheath.
在一方面,浮動心軸可包含一肩部,該肩部配置為當外護套縮回時接合並抵抗血管連接器的近端縱向運動。In one aspect, the floating mandrel can include a shoulder configured to engage and resist proximal longitudinal movement of the vessel connector when the outer sheath is retracted.
在一方面,可透過外護套看到血管連接器。或者或另外,外護套可具有一標記,該標記配置為在該外護套縮回之前指示該血管連接器的位置。In one aspect, the vascular connector is visible through the outer sheath. Alternatively or additionally, the outer sheath may have a marking configured to indicate the position of the vessel connector prior to retraction of the outer sheath.
在一方面,血管連接器可為一自膨式連接器,並能在19℃至37℃之溫度範圍內保持徑向力。In one aspect, the vascular connector can be a self-expanding connector capable of maintaining radial force over a temperature range of 19°C to 37°C.
在一方面,浮動心軸及內護套可具有一導引線管腔。In one aspect, the floating mandrel and inner sheath can have a guide wire lumen.
本揭示亦包括一種用於在病患體內植入血管連接器的方法。該方法包括提供一血管連接器置放工具,該血管連接器置放工具包括一殼體;一內護套,其從體殼向遠側延伸,其中內護套可相對於殼體旋轉;一浮動心軸;一連接器,其將浮動心軸耦合至內護套遠端,從而內護套能相對於浮動心軸旋轉;一血管連接器,其圍繞心軸同軸設置,及一外護套,可伸縮地置放於一內護套上,其中當外護套設置在血管連接器上時,該外護套配置為束縛血管連接器呈一插入外形圍繞該心軸。血管連接器的至少遠端部分可定位於用於引導患者血液的一第一管腔內。可旋轉內護套使外護套相對於浮動心軸縮回並露出血管連接器的遠端部分。可藉由使血管連接器的一部分從插入外形擴張,將血管連接器的遠端部分固定在第一管腔內。The present disclosure also includes a method for implanting a vascular connector in a patient. The method includes providing a vascular connector deployment tool comprising a housing; an inner sheath extending distally from the body housing, wherein the inner sheath is rotatable relative to the housing; a floating mandrel; a connector coupling the floating mandrel to the distal end of the inner sheath so that the inner sheath can rotate relative to the floating mandrel; a vessel connector coaxially disposed about the mandrel, and an outer sheath , telescopically placed on an inner sheath, wherein when the outer sheath is disposed on the vascular connector, the outer sheath is configured to constrain the vascular connector in an insertion configuration around the mandrel. At least a distal portion of the vascular connector is positionable within a first lumen for conducting blood from a patient. A rotatable inner sheath retracts the outer sheath relative to the floating mandrel and exposes the distal portion of the vascular connector. The distal portion of the vessel connector can be secured within the first lumen by expanding a portion of the vessel connector from the insertion configuration.
在一方面,內護套的旋轉可使設置在殼體內並耦合至外護套近端的驅動器縱向移動。旋轉內護套包括給予一第一預定的旋轉量以引起外護套的一第一已知的縱向運動量,使得第一已知的縱向運動量露出血管連接器的遠端部分。In one aspect, rotation of the inner sheath longitudinally moves a driver disposed within the housing and coupled to the proximal end of the outer sheath. Rotating the inner sheath includes imparting a first predetermined amount of rotation to cause a first known amount of longitudinal movement of the outer sheath such that the first known amount of longitudinal movement exposes the distal portion of the vessel connector.
在一方面,進一步的操作可包括在置放工具上同軸地推進用於引導患者血液的一第二管腔,直到第二管腔的末端與第一管腔的開口相鄰。旋轉內護套進一步使外護套相對於浮動心軸縮回並露出血管連接器的剩餘部分。可藉由使血管連接器的一部分從插入外形擴張將血管連接器的剩餘部分固定在第二管腔內。進一步旋轉內護套可包括給予內護套一第二預定的旋轉量以引起外護套的一第二已知的縱向運動量,使得第二已知的縱向運動量露出血管連接器的近端部分。In one aspect, the further manipulation may include coaxially advancing a second lumen for conducting the patient's blood over the deployment tool until an end of the second lumen is adjacent the opening of the first lumen. Rotating the inner sheath further retracts the outer sheath relative to the floating mandrel and exposes the remainder of the vessel connector. The remainder of the vessel connector can be secured within the second lumen by expanding a portion of the vessel connector from the insertion configuration. Further rotating the inner sheath may include imparting a second predetermined amount of rotation to the inner sheath to cause a second known amount of longitudinal movement of the outer sheath such that the second known amount of longitudinal movement exposes the proximal portion of the vessel connector.
在一方面,第一管腔為一血管,且第二管腔為一移植物。In one aspect, the first lumen is a blood vessel and the second lumen is a graft.
在一方面,將血管連接器的至少遠端部分定位於第一管腔內可包括通過外護套可見到血管連接器。或者或另外,將血管連接器的至少遠端部分定位於第一管腔內可包括使用一標記,該標記在外護套縮回之前指示該血管連接器的位置。In one aspect, positioning at least the distal portion of the vascular connector within the first lumen can include making the vascular connector visible through the outer sheath. Alternatively or additionally, positioning at least the distal portion of the vascular connector within the first lumen may include using a marker indicating the position of the vascular connector prior to retraction of the outer sheath.
一開始要瞭解到的是,本發明不限於本身可變化的特別例示的材料、結構、程序、方法或構造。因此,雖然有許多前述選項,那些相似或等同於本案所描述者可應用於本發明的實施或實施例,本案描述較佳的材料及方法。It should be understood at the outset that this invention is not limited per se to particularly exemplified materials, structures, procedures, methods or configurations, which may vary. Thus, while there are many of the foregoing options, those similar or equivalent to those described herein can be used in the practice or embodiment of the invention, which describes the preferred materials and methods.
亦要瞭解到的是,本案所使用的術語僅是為了描述本發明的特定實施例之目的而並非意欲限制的。It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting.
與隨文檢附的圖式有關的下面載明的詳細說明被認為是本發明的例示性實施例的說明而並非意欲表示可實施本發明的唯一例示性實施例。在本案全文說明書中所使用的術語「例示性」意指「用作一實例、例子或示例」,且不應必然地解釋為較佳或優於其它例示性實施例。詳細說明包括特定的細節供用於提供全面瞭解本案說明書的例示性實施例之目的。對於本發明所屬技術領域中具有通常知識者而言可顯而易見的是,本案說明書的例示性實施例可不用這些特定的細節而實施。在一些例子中,熟知的構造及裝置是以方塊圖形式來顯示,以避免混淆本案呈現的例示性實施例之新穎性。The detailed description set forth below in relation to the accompanying drawings is to be considered a description of exemplary embodiments of the invention and is not intended to represent the only exemplary embodiments in which the invention may be practiced. The term "exemplary" as used throughout the present specification means "serving as an example, instance, or illustration" and should not necessarily be construed as preferred or superior to other exemplary embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the exemplary embodiments of the present description. It will be apparent to those having ordinary skill in the art to which this invention pertains that the illustrative embodiments described herein may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the illustrative embodiments presented herein.
僅供方便及清楚之目的,有關隨文檢附的圖式之諸如上、下、左、右、低於、高於、上方、下方、下面、後面、後方及前方之方向性術語可使用。這些類似的方向性術語不應以任何方式解釋為限制本發明的範疇。For convenience and clarity purposes only, directional terms such as up, down, left, right, below, above, above, below, below, behind, behind and forward may be used with respect to the attached drawings. These similar directional terms should not be construed in any way as limiting the scope of the invention.
除非另外有所定義,在本案中所使用的所有技術性與科學術語具有熟悉本發明所屬技術的人士所共同瞭解的相同意義。如本文件中使用的及本技術中領域中通常使用,術語「實質上」及類似的近似術語係指由製造公差和其他製造不精密度所導致的成品尺寸和其他特性的正常變化。最後,除非上下文另外清楚地指明,如本說明書及隨文檢附的申請專利範圍中所用的,單數形式「一」、「一種」及「該」包括複數指示對象。Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the art to which this invention belongs. As used in this document and commonly used in the art, the term "substantially" and similar similar terms refer to normal variations in finished product dimensions and other characteristics resulting from manufacturing tolerances and other manufacturing imprecisions. Finally, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.
參照圖1,顯示一血管連接器10,其可適用於主動脈或病患管脈系統中的其他合適位置,以藉由將血管12(例如可切開的血管)連接到移植物14(例如分支移植物)協助建立或恢復流體或血液連通。移植物14可由任何合適的物質或材料製成,例如但不限於聚四氟乙烯(PTFE)或聚酯,例如聚對苯二甲酸乙二酯(PET),有時稱為DACRON®品牌聚酯,可自E. I. Du Pont De Nemours and Company of Wilmington,Delaware獲得。血管連接器10可從第一插入直徑擴展至第二置放直徑,並具有能使一第一插入直徑擴展到一第二置放直徑並以該擴展狀態牢固地保持血管連接器在血管12及移植物14內的任何結構。如一個實例,血管連接器10可包括複數個向周圍延伸的環箍16,設計類似於支架。環箍16可被縱向間隔開,而於此狀況下則相鄰之環箍16可藉由一個或多個繫桿18連接。或者,相鄰的環箍16並未被間隔開,而是相互鄰接或重疊。在這種構型中,此種相鄰的環箍16可被相互固定,例如藉由雷射焊接。環箍16可由金屬或其他材料製成。各環箍16可具有複合形狀,其中環箍16由金屬線製成,或藉由雷射切割管狀物,或以其他方式製造,使得環箍16具有複合形狀,例如鋸齒狀、重複Z字形、曲折曲線或其他形狀。此類形狀可使環箍16由插入直徑擴展成置放直徑。至少一個環箍16的鋸齒狀型式可被連續彎曲,或可包括由彎曲區段連接的直線區段。在一實施方式中,環箍16的鋸齒狀型式可例如在已屆期之美國專利號4,580,568所示者,該專利全部內容藉由引用併入本文。然而,環箍16可以不同方式配置。Referring to FIG. 1 , a
在一實施方式中,不同的環箍16可由不同的材料製成。例如,至少一個環箍16可由超彈性材料製成,例如鎳鈦合金,且至少一個其他環箍16可由可塑性變形材料製成,例如316L不銹鋼。相鄰的環箍16之間可以穿插不同材料,使得環箍16不與由相同材料組成的環箍16相鄰。在其他實施方式中,由相同材料組成的數個環箍16可組合在一起,且由不同材料組成的至少一個環箍16可與該組數個環箍16相鄰。例如,在血管連接器10外端處的環箍16可由不銹鋼構成,而其餘的環箍16可由例如鎳鈦合金的超彈性材料構成。藉由使用不同材料製成之環箍16,血管連接器10可取得這些不同材料之不同特性的優點。例如,由超彈性材料製成的一或多個環箍16有用於自我擴展血管連接器10。由例如316L不銹鋼之可塑性變形材料製成的一或多個額外環箍16可用於保持血管連接器10的管腔或腔體的擴展,因為此類材料對環箍應力具有更大的抵抗力,並且在擴展後不易回復到不同的晶相。此外,此類環箍16被製造成在結構上設定在19℃至37℃的溫度範圍內保持其徑向力。雖然在此文中使用術語「環箍」,但環箍16在端部觀察時並不需要是完美的圓形,並可具有適於特定應用的不同形狀和曲率。在一些實施方式中,環箍16在端部觀察時實質上是圓形的。In one embodiment,
在一實施方式中,血管連接器10的數個相對端在置放狀態下各自擴展成相同或相似的直徑。在其他實施方式中,在置放狀態下,一端擴張至與另一端不同的直徑,以允許連接具有不同直徑的血管12和移植物14。直徑的差異可藉由控制各端的環箍16的直徑、藉由提供具有不同材料的環箍16的不同組合或以任何其他適當方式來控制。In one embodiment, several opposite ends of the
如上所述,血管連接器10可用於將血管12連接到移植物14,且對應地最好需要先將連接器10的一半長度置放於血管12中,然後將連接器10的另一半置放於移植物14中以有效地將血管12連接到移植物14。將適量的連接器10準確地置放至血管12及移植物14兩者中是有利的,因為在血管12中置放太多的連接器10會危及移植物14內的連接,而在血管中置放的連接器10太少則會危及血管12內的連接,且應當理解,這兩種情況對病患而言都是災難性的。適當的可視化大大地促進了任何開放式外科手術,因此本發明揭示之技術提高在手術期間準確評估連接器10在血管12或分支移植物14內之適當量的能力,如下文詳細討論。As mentioned above, the
因此,血管連接器10或具有類似特性的連接器可使用置放工具20置放,在圖2中以截面方式呈現而在圖3則以爆炸視圖方式部分地示意地描繪各種組件的同軸關係。置放工具20包括殼體22,殼體22包含耦合至外護套26並由內護套28的旋轉所驅動的螺帽驅動器24。在置放工具20的遠端處是浮動心軸30,其具有鈍的、無創傷性尖端32。如圖所示,血管連接器10圍繞浮動心軸30並藉由外護套26至少部分地抵靠浮動心軸30保持其壓縮構型。外護套26可伸縮地設置在內護套28、浮動心軸30和連接器10上,並可經由內護套28的旋轉選擇性地縮回。特別是,螺帽驅動器24具有在殼體22的導軌36內縱向移動的凸出部34,這些組件顯示於圖2的詳細插圖中。螺帽驅動器24亦具有內螺紋38,而內螺紋38與內護套28近端部分上的外螺紋40嚙合,則具有導螺桿之功效以對應於內護套28的旋轉而產生所需的縱向運動。由於外護套26耦合至螺帽驅動器24,螺帽驅動器24的近側移動產生外護套26的對應縮回以露出並置放連接器10,如下文進一步詳細描述。如圖3所示,滾珠42和插孔44的耦合可保持浮動心軸30相對於內護套28的相對縱向位置,但允許內護套28在置放期間自由旋轉。肩部46具有與外護套26之內徑相似的外徑,當外護套縮回時在置放期間抵抗連接器10非預期的近側移動。在替代的實施方式中,相似的功能可藉由位於內護套28遠端附近的肩部結構提供。通過浮動心軸30和內護套28提供導引線管腔48,以便於將置放工具20推進至患者脈管系統內的期望位置。Thus,
在一個實施方式中,內護套28近端處的介面50配置為與機械臂或類似工具配合,從而可在機器控制下完成連接器10的遞送或設置。值得注意的是,可對內護套28施加精確的旋轉量,以實現外護套26的類似精確的縮回量,如此將有利於上述連接器10的多階段遞送。然而,在其他實施方式中,內護套28亦可被手動驅動,並可具有適於該目的的手柄或其他致動器。In one embodiment, the
外護套26可在縮回之前覆蓋血管連接器10的整個長度,並且可能希望基於連接器10的特性和置放程序目標,依序地置放連接器10的不同預定部分。以下例用於說明(而非限制),7公分的連接器的遠端3.5公分部分可在第一階段期間置放於患者的天然血管12中,然後在適當定位後,剩餘的近端3.5公分部分可置放在移植物14中。距離可依據連接器10的長度和所期望被覆蓋的比例依需要而改變。外護套26可由合適的聚合材料形成,諸如尼龍(聚醯胺)、胺甲酸乙酯、聚丙烯以及聚醯胺共聚物,例如聚醚嵌段醯胺(PEBAX®),或可使用其他材料。在一些實施方式中,外護套26具有足夠半透明特性以允許連接器10的可視化,以幫助確保正確放置,諸如藉由使用實質上清澈透明的聚合物。應可知悉地,清晰度是相對的,且為了本揭示之目的,足使連接器10能夠透過外護套26可見的任何光學特性差異,均可使用。或者,外護套26可具有標記52以指示連接器10的相對位置。例如,標記52可表示在外護套26的任何縮回之前連接器10的中點。
如將理解的,外護套26可受控的縮回量有利於連接器10在血管12和移植物14內的準確置放。例如於涉及連接器10的對稱置放程序中,可藉由定位置放工具20以使連接器10置放於血管12內(亦可能在機器自動控制下),並給予內護套28已知的旋轉量,使得連接器10的一半露出並置放。隨後,在將移植物14定位在連接器10的近端部分上之後,可給予內護套28另一已知的旋轉量以完成置放。再一次,應該理解,如果需要,亦可動手執行內護套28的旋轉以置放連接器10。As will be appreciated, the controlled amount of retraction of
僅作為說明而非限制,圖4-7示意地描繪使用置放工具20以連接器10將血管12連接至移植物14。如圖4所示,基於通過外護套26的可視化或連接器、標記52的使用或這些和其他技術的組合,置放工具20可被推進到血管12(可能在穿過管腔48的導引線上,但為了清楚起見,在此視圖中未顯示)中,直到期望數量的連接器10已被設置在血管12內。接著,圖5示意地示出由於內護套28的旋轉而被設置在血管12內的連接器10的遠端部分的置放。如所指出的,此可藉由經介面50給予預定的旋轉量在機器自動控制下執行。如上所述,與螺帽驅動器24之內螺紋38接合的外螺紋40之導螺桿功能將內護套28的旋轉轉換成外護套26的縱向運動,因為它耦合至螺帽驅動器24。具體而言,內護套28在適當方向上的旋轉致使外護套26縮回,將連接器10從其遠端到其近端依次露出。滾珠42和插孔44的耦合接合將浮動心軸30保持在置放工具20內相同的相對縱向位置,而並不隨內護套28旋轉。此外,肩部46有助於克服外護套26的摩擦以防止連接器10的縱向移位。如圖所示,外護套26的縮回允許現已露出之連接器10的遠側部分從浮動心軸30由其插入的外形擴展至其置放的外形以接合並固定血管12。接下來,如圖6所示,移植物14可在置放工具20上同軸推進直到其鄰近於血管12,例如藉由鄰接或以其他方式足夠接近。現在,內護套28的進一步旋轉致使外護套26的額外縮回以露出連接器10的剩餘近端部分,從而其可從其插入外形擴展到其展開外形以接合並固定移植物14。現在可向近端撤回置放工具20,將連接器12留在原位以連接血管12與移植物14。儘管圖4至7所示的實施方式討論在端對端構形中連接血管12與移植物14的情況,但該技術亦可施用於連接引導患者血液之血管、移植物或其他管腔的任何組合,且亦可與通過血管、移植物或其他管腔側壁上形成的開口的血管內途徑一起使用。By way of illustration only and not limitation, FIGS. 4-7 schematically depict connection of
雖然已經詳細描述本發明,但對於本領域技術人員來說顯而易見的是,在不背離本發明的情況下可進行各種變化和修正並採用等同物。應理解的是,本發明並不限於以上敘述所闡釋或圖示中所說明的構造細節、部件配置及/或方法。本文摘要中的陳述,及本文中的任概要陳述,僅為例示性;其等不是、亦不能被解釋為限制申請專利範圍的範圍。再者,圖示僅為例示性而非限制性的。局部標題及副標題僅為了方便讀者,其等不應也不能被解釋為具有任何實質意義、含義或解釋,且不應也不能被視為表明與任何特定議題有關的所有信息都應在任何特定標題或副標題下被尋得或被限制。因此,除了根據申請專利範圍及其法定等同物外,本發明不受拘束或限制。While the invention has been described in detail, it will be apparent to those skilled in the art that various changes and modifications can be made and equivalents employed without departing from the invention. It should be understood that the present invention is not limited to the details of construction, component arrangements and/or methods described above or illustrated in the drawings. The statements in the abstract of this article, and any general statements in this article, are illustrative only; they are not and cannot be construed as limiting the scope of the patent application. Again, the illustrations are illustrative only and not restrictive. Section headings and subheadings are for the convenience of the reader only and should not and cannot be construed as having any substance, implication or interpretation, and should not and cannot be taken to indicate that all information pertaining to any particular topic should be included in any particular heading or subtitles found or restricted. Accordingly, the invention is not to be restricted or restricted except in accordance with the claims and their legal equivalents.
10:血管連接器 12:血管 14:移植物 16:環箍 18:繫桿 20:置放工具 22:殼體 24:螺帽驅動器 26:外護套 28:內護套 30:浮動心軸 32:尖端 34:凸出部 36:導軌 38:內螺紋 40:外螺紋 42:滾珠 44:插孔 46:肩部 48:管腔 50:介面 52:標記 10: Vascular connector 12: blood vessel 14:Graft 16: hoop 18: tie rod 20: Placing tools 22: shell 24: Nut driver 26: Outer sheath 28: inner sheath 30: floating mandrel 32: tip 34: protruding part 36: guide rail 38: internal thread 40: external thread 42: Ball 44: jack 46: shoulder 48: lumen 50: interface 52: mark
有如隨文檢附的圖式所說明的,本揭示進一步的特徵及優點將從以下及較佳實施方式之更特定的說明中變得明顯,且其中類似的參考字元通常意指全文的相同部分或元件,及其中:Further features and advantages of the disclosure will become apparent from the following and more particular description of the preferred embodiment, as illustrated in the accompanying drawings, and wherein like reference characters generally mean the same throughout parts or elements, and of which:
圖1示意地說明根據本揭示之實施方式的一種用於連接血管和移植物的血管連接器。FIG. 1 schematically illustrates a blood vessel connector for connecting blood vessels and grafts according to an embodiment of the present disclosure.
圖2示意地說明根據本揭示之實施方式的一種用於定位和放置血管連接器的置放工具的局部剖面圖。2 schematically illustrates a partial cross-sectional view of a placement tool for positioning and placing a vascular connector according to an embodiment of the present disclosure.
圖3示意地描繪根據本揭示之實施方式的圖2之置放工具的組件的同軸關係爆炸視圖。FIG. 3 schematically depicts an exploded view of components of the placement tool of FIG. 2 in coaxial relationship, according to an embodiment of the present disclosure.
圖4示意地說明根據本揭示之實施方式,將血管連接器定位在血管內。Figure 4 schematically illustrates the positioning of a vascular connector within a blood vessel, according to an embodiment of the present disclosure.
圖5示意地說明根據本揭示之實施方式,縮回置放工具的外護套以允許血管連接器的遠側部分擴張而將其固定在血管內。5 schematically illustrates retraction of the outer sheath of the deployment tool to allow expansion of the distal portion of the vessel connector to secure it within the vessel, according to an embodiment of the present disclosure.
圖6示意地說明根據本揭示之實施方式,在置放工具上推進移植物,使其靠近血管。Figure 6 schematically illustrates advancing a graft over a placement tool to bring it closer to a blood vessel, according to an embodiment of the present disclosure.
圖7示意地說明根據本揭示之實施方式,置放工具的外護套的進一步縮回以允許血管連接器的剩餘部分擴張以將其固定在移植物中。7 schematically illustrates further retraction of the outer sheath of the deployment tool to allow expansion of the remainder of the vascular connector to secure it in the graft, according to an embodiment of the present disclosure.
10:血管連接器 10: Vascular connector
12:血管 12: blood vessel
14:移植物 14:Graft
16:環箍 16: hoop
18:繫桿 18: tie rod
Claims (20)
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US202163224561P | 2021-07-22 | 2021-07-22 | |
US63/224,561 | 2021-07-22 |
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TW111127602A TW202315591A (en) | 2021-07-22 | 2022-07-22 | Vascular and aortic connectors with robotic delivery |
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WO (1) | WO2023003842A1 (en) |
Family Cites Families (6)
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US7105016B2 (en) * | 2002-04-23 | 2006-09-12 | Medtronic Vascular, Inc. | Integrated mechanical handle with quick slide mechanism |
US6911039B2 (en) * | 2002-04-23 | 2005-06-28 | Medtronic Vascular, Inc. | Integrated mechanical handle with quick slide mechanism |
US7794489B2 (en) * | 2003-09-02 | 2010-09-14 | Abbott Laboratories | Delivery system for a medical device |
DE602004018665D1 (en) * | 2003-09-02 | 2009-02-05 | Abbott Lab | Delivery system for a medical device |
US20080294230A1 (en) * | 2007-05-24 | 2008-11-27 | Cook Incorporated | Apparatus and methods for deploying self-expanding stents |
US9393115B2 (en) * | 2008-01-24 | 2016-07-19 | Medtronic, Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
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2022
- 2022-07-19 WO PCT/US2022/037541 patent/WO2023003842A1/en unknown
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