Aortic diaphragm opening device

Abstract

An aortic fenestration device comprising: an outer sheath; a suction head operably coupled to the distal end of the outer sheath and having a suction opening; a fenestration element positioned within the outer sheath and extendable through the suction head to a position beyond the suction opening, for fenestrating tissue; a guidewire slidably positioned relative to the fenestration element and extendable to a position beyond the suction opening and the distal end of the fenestration element; and a suction source operably coupled to the outer sheath and configured to apply suction pressure at the suction opening of the suction head, selectively coupling the suction head to the tissue via suction pressure when the tissue is fenestrated. The fenestration element may have a needle wire and a needle wire catheter or a hollow needle.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 457,212, filed Apr. 5, 2023. The entire disclosure of the above application is incorporated herein by reference.

[0002] The present disclosure relates to the treatment of aortic dissection, and more particularly to an aortic septal fenestration device for the treatment of aortic dissection and / or related complications.

Background Art

[0003] In this section, background information is provided that is related to the present disclosure, but which is not necessarily prior art. This section provides an overview of the present disclosure and is not an exhaustive disclosure of all features of the present disclosure.

[0004] Aortic dissection occurs when there is a separation between the layers of the aortic wall, as shown in FIG. 1A. The aorta has three layers: the intima (the innermost layer, with one side facing the lumen of the blood vessel), the media (the middle layer), and the adventitia (the outermost layer). When there is a crack in the intima, blood fills the space between the layers of the aorta (creating a false lumen in the process), leading to aortic dissection. The pressurized blood in this false lumen can potentially promote the progression of the dissection.

[0005] Aortic dissection can prevent proper blood flow and potentially reduce blood flow to organs (referred to as organ perfusion impairment), increasing the risk of serious organ damage due to ischemia. The dissection can compress the true lumen of the aorta, significantly weakening the blood flow in the branch vessels (the blood vessels that carry blood from the aorta to each organ and limb). The blood flow to the branch vessels can be weakened when the false lumen invades the true lumen of the branch vessel.

[0006] The outer wall of the false lumen (tunica media and adventitia) is weaker than that of the three layers combined, creating a risk of rupture or aneurysmal degeneration in patients with aortic dissection. Furthermore, a pressurized false lumen increases the risk of organ perfusion impairment or other serious life-threatening complications such as aortic rupture.

[0007] Aortic dissection is classified into two types. As shown in Figure 1B, type A aortic dissection involves the aorta proximal to the brachiocephalic artery (closer to the heart) and requires immediate surgery. As shown in Figure 1C, type B aortic dissection involves the descending aorta and is distal to the left subclavian artery. Organ perfusion impairment can result from both types of aortic dissection. If organ perfusion impairment is absent, type B dissection may be treated without surgical intervention. Furthermore, type B aortic dissection can be subdivided into acute (less than 3 months from onset) and chronic (more than 3 months from onset) type B aortic dissection based on the chronicity of the dissection. While organ perfusion impairment is one of the main reasons for requiring surgical intervention in "acute" aortic dissection, the most common reason for surgical intervention in patients with "chronic" type B aortic dissection is aortic aneurysm formation due to loss of aortic wall integrity caused by acute aortic dissection.

[0008] While some acute type B aortic dissections can be managed medically, other cases of acute type B dissection, as well as all cases of acute type A dissection, which are accompanied by complications such as impaired organ perfusion, aortic rupture, refractory hypertension, and persistent pain, require surgical intervention. The cornerstone of surgical intervention for acute type A dissection is cardiac incision. Surgical intervention for acute type B dissection with complications involves intravascular introduction of a stent placed across the dissection site to cover the entry tear that creates the dissection and to ensure that blood flows only through the true lumen. However, stent treatment requires introducing a device into the fragile dissected aorta, is not always effective in correcting impaired organ perfusion, and is time-consuming. Furthermore, stent treatment alone carries the risk of complications such as new entry tears induced by the stent as a result of introducing a device into the fragile aorta, as well as the risk of lifelong device infection. These new entry tears lead to a further risk of impaired organ perfusion and future aneurysm formation. Patients undergoing stent placement require lifelong prophylactic antibiotics whenever they undergo procedures to prevent stent device infection, such as dental procedures. A more effective and ideal treatment option for correcting organ perfusion impairment is aortic fenestration, which involves creating an additional hole in the aortic diaphragm to restore blood flow to the true lumen and peripheral organs. However, aortic fenestration is a very high-risk and technically difficult procedure that requires the use of off-label devices. No dedicated medical device for this purpose existed.

[0009] Surgical treatment of aortic aneurysms associated with chronic type B aortic dissection is accompanied by extremely high mortality and complication rates. Therefore, less invasive treatments, such as endovascular treatment with stents, would be ideal for high-risk patients with comorbidities. However, stent placement is often ineffective for chronic type B aortic dissection because the presence of a rigid aortic diaphragm hinders proper stent apposition to the aortic wall. Unfortunately, a significant number of patients are deemed unsuitable for surgical treatment or less invasive stent placement due to comorbidities and the lack of suitable anatomical sites for stent placement. When a patient is unsuitable for standard cardiac surgery or stent placement, procedures can be taken to provide a better stent placement site. Aortic fenestration is highly effective in the clinical setting of chronic type B aortic dissection by optimizing endograft placement.

[0010] Aortic fenestration is performed as an endovascular procedure. However, there are currently no available specialized devices, making it a highly technical procedure that many physicians cannot confidently perform in the field of aortic dissection. Therefore, it is not currently performed in most facilities. As a result, organ perfusion impairment due to "acute" aortic dissection may never be fully treated, leading to extremely high mortality rates, and potentially resulting in unoptimized or even unavailable stent-graft placement for "chronic" type B aortic dissection.

[0011] Current techniques for performing aortic fenestration involve using a catheter equipped with an energy source (electrocautery, radiofrequency ablation, laser) to cross the diaphragm or using an intravascular needle to create a hole in the diaphragm. None of these devices are intended for aortic fenestration, and these are off-label device-using procedures. Furthermore, these techniques are universally difficult and not widely practiced. In chronic diaphragms, the tissue between the true lumen and false lumen is thicker, making fenestration more difficult. Needles or catheters equipped with energy sources can be difficult to control, and compression to the diaphragm can be technically challenging. This can lead to potentially life-threatening complications, such as severe aortic damage that could result in aortic rupture.

[0012] In acute aortic dissection, the diaphragm often shifts, the true lumen can be severely compressed, and the false lumen is prone to compression. This means that using inappropriate diaphragmatic fenestration techniques, such as simple needles, can be difficult to capture the target aortic diaphragm, increasing the risk of perforating the aortic lateral wall and potentially causing significant bleeding. [Overview of the Initiative]

[0013] In accordance with the principles of this teaching, an aortic fenestration device with an advantageous structure and method of use is provided. In some embodiments, the aortic fenestration device comprises an outer sheath; a suction head operably coupled to the distal end of the outer sheath and having a suction opening; a fenestration element positioned within the outer sheath and extendable through the suction head to a position beyond the suction opening, fenestrating tissue; a guidewire slidably positioned relative to the fenestration element and extendable to a position beyond the suction opening and the distal end of the fenestration element; and a suction source operably coupled to the outer sheath and configured to apply suction pressure at the suction opening of the suction head, selectively coupling the suction head to the tissue via suction pressure when the tissue is fenestrated. The fenestration element may have a needle wire and a needle wire catheter or a hollow needle.

[0014] In some embodiments, the aortic fenestration device comprises a sheath containing at least one lumen; a suction head operably coupled to the distal end of the sheath and having a lumen and a suction opening; a needlewire catheter slidably positioned within the sheath and extending through the suction head to a position beyond the suction opening; a needlewire slidably positioned within the needlewire catheter and extending through the needlewire catheter to a position beyond the suction opening and the distal end of the needlewire catheter; and a suction source operably coupled to the sheath and applying suction pressure at the suction opening of the suction head, thereby selectively binding the suction head to tissue via the suction pressure.

[0015] In another embodiment, the aortic fenestration device includes a sheath containing at least one lumen; a suction head operably coupled to the distal end of the sheath and having a lumen and a suction opening; a hollow needle slidably positioned within the sheath and extending through the suction head to a position beyond the suction opening; a hollow needle advance slider and an external handle for controlling the orientation and positioning of the hollow needle; a guidewire slidably positioned within the hollow needle and extending through the hollow needle to a position beyond the suction opening and the distal end of the hollow needle; and a suction source operably coupled to the sheath and applying suction pressure at the suction opening of the suction head, thereby selectively coupling the suction head to tissue via the suction pressure.

[0016] Further applicable scope will become apparent from the descriptions provided herein. The descriptions and examples in this summary are for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0017] The drawings described herein are for illustrative purposes only of selected embodiments and not of all possible implementations, and are not intended to limit the scope of this disclosure. [Brief explanation of the drawing]

[0018] [Figure 1A] This shows aortic dissection. [Figure 1B] Shows type A aortic dissection. [Figure 1C] Shows type B aortic dissection. [Figure 2] Perspective view of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 3] Plan view of the aortic fenestration device, excluding a part, according to some embodiments of the present disclosure. [Figure 4] Shows the valve port device. [Figure 5] Enlarged view of the suction head according to some embodiments of the present disclosure. [Figure 6] Enlarged view of the suction head according to some embodiments of the present disclosure. [Figure 7] Enlarged side cross-sectional view of the suction head according to some embodiments of the present disclosure. [Figure 8] Enlarged end cross-sectional view of the suction head according to some embodiments of the present disclosure. [Figure 9] Enlarged perspective view of the suction head from a perspective that hides a part according to some embodiments of the present disclosure. [Figure 10] Perspective view of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 11] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 12] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 13] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 14] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 15] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 16] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 17] Operation diagram of the aortic fenestration device according to some embodiments of the present disclosure. [Figure 18A] This is a fluoroscopic view of an aortic fenestration device with an articulated section, according to some embodiments of this instruction. [Figure 18B] This is an enlarged view of the joint movement section according to some embodiments of this instruction. [Figure 19] This is a plan view of an aortic fenestration device with an articulated section according to some embodiments of this instruction. [Figure 20] This is an enlarged side cross-sectional view of a suction head according to some embodiments of this instruction. [Figure 21] This is a side cross-sectional view of a handle assembly according to some embodiments of this instruction. [Figure 22A] This is a diagram illustrating the operation of an aortic fenestration device according to some of the embodiments described in this instruction, showing needle extension. [Figure 22B] This diagram shows the operation of an aortic fenestration device according to some of the embodiments described in this instruction, illustrating the extension of the guidewire. [Figure 23A] This is an enlarged view of the guide feature and suction channel according to some embodiments of this instruction. [Figure 23B] This is an enlarged view of the guide feature and suction channel according to some embodiments of this instruction. [Figure 24] This is an enlarged cross-sectional view of an aspiration channel according to some embodiments of this instruction. [Figure 25] This is a magnified perspective view of an aspiration channel according to some embodiments of this instruction. [Figure 26] This is an enlarged end cross-sectional view of a suction head according to some embodiments of this instruction. [Figure 27A] This diagram shows the operation of an aortic fenestration device and needle according to some embodiments of this instruction. [Figure 27B] This diagram shows the operation of an aortic fenestration device and needle according to some embodiments of this instruction. [Figure 27C] This diagram shows the operation of an aortic fenestration device and needle according to some embodiments of this instruction. [Figure 27D]This diagram shows the operation of an aortic fenestration device and needle according to some embodiments of this instruction. [Figure 28] This is a magnified perspective view of a suction head equipped with bipolar electrodes, according to some embodiments of this instruction. [Figure 29] This is a magnified perspective view of a suction head equipped with a balloon expansion mechanism, according to some embodiments of this instruction. [Figure 30A] This is a magnified perspective view of a suction head equipped with a laser, according to some embodiments of this instruction. [Figure 30B] This is a fluoroscopic view of a laser-equipped aortic fenestration device, following some embodiments of this instruction. [Modes for carrying out the invention]

[0019] Matching reference numbers indicate parts that match across various perspectives in the drawing.

[0020] Here, the exemplary embodiments will be described in more detail with reference to the attached drawings.

[0021] Exemplary embodiments are provided to complete the disclosure and to fully convey its scope to those skilled in the art. Numerous specific details are provided, including specific components, devices, and method examples, for a full understanding of the embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, that the exemplary embodiments may be embodied in many different forms, and that none of these should be construed as limiting the scope of this disclosure. Some exemplary embodiments do not describe in detail well-known processes, well-known device structures, and well-known techniques.

[0022] The technical terms used herein are intended solely to describe, and not to limit, specific exemplary embodiments. In this specification, the singular forms “a,” “an,” and “the” may also be intended to include the plural form unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having” are inclusive; they identify the presence of the presented features, integers, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof. The method steps, processes, and actions described herein should not be construed as necessarily having to be performed in a specific order described or illustrated, unless specifically identified as such. Furthermore, it should be understood that additional or alternative steps may be employed.

[0023] When an element or layer is referred to as “on,” “engaged,” “connected,” or “joined” another element or layer, it may be directly on, engaged, connected, or joined to the other element or layer, or there may be an intervening element or layer. In contrast, when an element is referred to as “directly on,” “directly engaged,” “directly connected,” or “directly joined” another element or layer, there may be no intervening element or layer. Other words used to describe relationships between elements should be interpreted similarly (e.g., “directly between” versus “directly adjacent” versus “directly adjacent”). In this specification, the term “and / or” includes any combination of one or more of the related enumerated items.

[0024] This specification may use terms such as "first," "second," and "third" to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Where "first," "second," and other numerical terms are used herein, they do not imply order or sequence unless clearly indicated by the context. Accordingly, a first element, component, region, layer, or section described later may be referred to as a second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0025] Spatially relative terms such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” and “upper” may be used herein to facilitate descriptions of the relationship between one element or feature and another, as illustrated. Spatially relative terms may be intended to encompass various orientations of the device in use or operation, in addition to the illustrated orientation. For example, if the illustrated device is turned upside down, an element described as being “below” or “below” other elements or features would be facing “above” other elements or features. Thus, the illustrated term “below” can encompass both upward and downward orientations. The device may also be oriented in other orientations (rotated 90 degrees, or in other orientations), and the spatially relative descriptive terms used herein may be interpreted accordingly.

[0026] This instruction aims to reduce the technical requirements of aortic fenestration and make the procedure more accessible by providing an intravascular catheter device and a method of using the same, in accordance with the principles of this instruction. Intravascular catheter-based devices are typically configured to be advanced into the aorta, blood vessel, or other tubular anatomical structure until the device reaches the site where the fenestration is to be performed. In some embodiments, suction is applied to attach the device head to the aortic diaphragm. Suction is transmitted to the device head by a small-bore catheter and occurs externally. In some embodiments, a needle wire is then advanced through the catheter and penetrates the aortic diaphragm. In some embodiments, the needle catheter slides along the needle wire into the false lumen. The needle wire is removed and a guide wire is placed in the false lumen through the needle catheter. The device is removed from above the guide wire, leaving the guide wire in place in the false lumen.

[0027] In some embodiments, instead of a needle wire, a cannula, i.e., a hollow needle, is used to penetrate the aortic diaphragm, and a guidewire is advanced through the lumen of the hollow needle into a false lumen. The device is then removed from above the guidewire, leaving the guidewire in place within the false lumen. While other devices for aortic fenestration certainly exist, none of those devices are capable of producing aspiration or providing the advantages and benefits of this teaching.

[0028] More specifically, an intravascular catheter-based device (hereinafter referred to as the aortic fenestration device 10) is provided that is configured, fitted, and operable to create a fenestration in the aortic diaphragm 1000 according to the principles of this teaching. In some embodiments, the aortic fenestration device 10 typically includes components that allow for temporary and / or selective attachment to the aortic diaphragm 1000 by suction. In some embodiments, alternative means for temporary and / or selective attachment of the aortic fenestration device 10 to the aortic diaphragm 1000 may be used, including but not limited to balloon attachments (see Figure 29) and other systems. The distal end of the aortic fenestration device 10 is attached to the aortic diaphragm 1000 via a suction head in some embodiments, but a fenestration element such as a needle wire (see Figures 2 to 17), a hollow needle (Figures 18A to 27D), or a laser fenestration member (see Figures 30A to 30B) is advanced to provide access to a false lumen. Once access to the false lumen is possible, the guidewire is advanced through the aortic fenestration device 10 into the false lumen, and the aortic fenestration device 10 is removed.

[0029] In some embodiments, the aortic fenestration device 10 provides access to a false lumen. In this case, “access” means the placement of a guidewire into the false lumen. In some cases, the aortic fenestration device 10 is used to advance from the access vessel into the false lumen, across the diaphragm, and into the true lumen. Guidewire access allows surgeons to perform a variety of additional treatments and / or life-saving procedures, including but not limited to false lumen decompression, fenestration dilation, branch vessel stenting, septal incision, and diagnostic angiography.

[0030] Currently, while products exist that provide the function of creating a fenestration in the aortic diaphragm 1000 using a needle or laser, no product exists that provides stable and reliable compression to the diaphragm in a controlled manner, either by generating suction or by other means such as balloon expansion. In some embodiments of this teaching, the aortic fenestration device 10 is fitted to the aortic diaphragm 1000 using one or more openings on a suction head. A needle or laser is then advanced through or adjacent to the suction head to create a diaphragmatic fenestration. In some embodiments, suction is delivered to the suction head via a small-bore catheter and is generated externally. In some embodiments, both suction and needle or laser fenestration are transmitted via a catheter or multiple separate catheters. These catheters can also be used to advance the aortic fenestration device 10.

[0031] Referring particularly to Figures 2 and 3, in some embodiments the aortic fenestration device 10 may include a device or suction head 12, an outer sheath or housing 14, a needle exit locking mechanism 18, a Luer-type suction port (e.g., a hemostatic valve) 20, a needle wire 22 with an advancement mechanism device 24 at its proximal end, a needle wire catheter 26, a guide wire 28, and a locking suction syringe or other means 30 for generating suction.

[0032] Referring particularly to Figures 18A to 22B, in some embodiments the aortic fenestration device 10 may have a suction head 12, an outer sheath 14, a handle 16, a needle exit locking mechanism 18, a Luer-type suction port (e.g., a hemostatic valve) 20, a needle 22' with an advancement mechanism 24 at its proximal end, a guide wire 28, and a locking suction syringe or other means 30 for generating suction.

[0033] [Suction head] In some embodiments, as shown in Figures 2-3, 5-10, 18A-20, and 22A-26, the suction head 12 can facilitate selective, temporary, and / or secure suction connection or coupling between the suction head 12 and the aortic tissue 1000 by having one or more suction openings 32. The size of the suction openings 32 is maximized to improve suction transmission and attachment of the suction head 12 to the aortic diaphragm 1000. In some embodiments, the shape of the suction openings 32 is circular, elliptical, egg-shaped, or curved to enhance tissue engagement and / or adapt to tissue irregularities during suction connection or coupling. In some embodiments, the suction openings 32 have an egg-shaped, smooth wall shape to prevent loss of suction at corners and edges. In some embodiments, the inner wall of the suction openings 32 is serrated, uneven, and / or grooved to improve attachment and fixation to the diaphragm 1000 under negative pressure.

[0034] In some embodiments, the suction head 12 may further have a needle catheter opening 34. In some embodiments, the suction head 12 may have a head with a non-damaging / smooth shape that allows for improved maneuverability. In some embodiments, the suction head 12 may be inserted into or otherwise coupled to other catheter portions.

[0035] During operation, the suction head 12 transmits suction from the catheter to the aortic diaphragm 1000 and may remain in place while the needle wire 22, needle 22', and / or needle wire catheter 26 advance across the aortic diaphragm 1000.

[0036] [Outer sheath] In some embodiments, the outer sheath 14 may have an outer sheath and / or housing configuration extending over the distance between the user interface (e.g., the handle 16) and the suction head 12. In some embodiments, the outer sheath 14 may have a single-lumen catheter 38 for passing a needle wire catheter 26 and / or needle 22' with negative pressure. In some embodiments, the outer sheath 14 may have a second lumen used for negative pressure exchange between the suction source 30 and the suction head 12.

[0037] In some embodiments, the outer sheath 14 may have a semi-rigid outer wall 40 that transmits negative pressure, is deflectable and / or maneuverable, and can withstand compression while being located within a pressurized aorta. In some embodiments, the outer sheath 14 is composed of one or more layers to achieve desired mechanical properties. In some embodiments, the outer sheath 14 may have one or more materials having different hardnesses and located in different positions, including but not limited to medical-grade polyether block amide or nylon. In some embodiments, the material hardness of one or more sections may be between Shore D20 and 90, but other hardnesses may be used. In some embodiments, the outer sheath 14 may be made from a medical-grade thermoplastic material and may include a one-piece metal braid or coil structure that helps provide adequate strength while maintaining flexibility. In some embodiments, a portion of the outer sheath 14 may include an indicator component and / or radiopaque marker that indicates the direction of pre-curve or bend in the distal portion and / or allows for the detection of the real-time position and / or positioning of other notable portions of the suction head 12 or the aortic fenestration device 10.

[0038] In some embodiments, the outer sheath 14 can be maneuverable and / or may include pre-curving. In some embodiments, the shape and maneuverability of the outer sheath 14 allow the suction head 12 to press against the aortic diaphragm 1000. In some embodiments, as shown in Figures 18A to 19, the aortic fenestration device 10 is configured to articulate or deflect portions 44 such as the distal portion and / or a separate or continuous intermediate portion 44' of the outer sheath 14. That is, the articulation may be along one or more sections of the outer sheath 14, depending on the navigation requirements of the surgical application. The magnitude and direction of the articulation / deflection of the outer sheath 14 may be controlled by an outer sheath articulation assembly 70 (Figures 18A, 19, and 21), so that the user can select the degree of articulation / deflection by increasing or decreasing the operation of the outer sheath articulation assembly 70. In some embodiments, the articular movement / deflection of the outer sheath 14 can be controlled, for example, by utilizing one or more pull wires 72 integrated within the outer sheath 14 (Figures 21 and 26). In some embodiments, as shown in Figure 26, the pull wires 72 may be positioned along the side of the outer sheath 14 (i.e., offset from the longitudinal axis) or within the wall of the outer sheath 14 on the same side as the opening 32, applying a bending force that facilitates articular movement in the direction of the suction opening 32. Articular movement may also be controlled using pull wires 72 in other orientations and quantities.

[0039] The pull wire 72 can be connected to the mechanism of the outer sheath articulation assembly 70 within the handle 16. In some embodiments, the outer sheath articulation assembly 70 may have a rotating member 74 (such as a rotating member that moves back and forth in response to the rotating member 74 and screws into a corresponding screw system 76), thereby driving the pull wire 72 to generate a bending force and articulate / bend the corresponding section or area of ​​the outer sheath 14. However, it should be understood that alternative drive systems, such as a thumb toggle, may be used. In some embodiments, the outer sheath articulation assembly 70 can maintain articulation of the outer sheath 14 even when not actively held. This allows the operator to set the desired articulation of the outer sheath 14 and then free their hand to perform other tasks.

[0040] [Features of the suction head] In some embodiments, externally generated suction is sent to the suction head 12. In some embodiments, the suction head 12 is coupled to the outer sheath 14 and has a suction head lumen 36 that is continuous with and / or coaxial with the outer sheath 14 and continuous with the lumen 38 of the outer sheath 14 (e.g., outer sheath lumen 38). The suction head lumen 36 terminates with a suction opening 32, which is located on a single surface of the suction head 12 and functions to transmit suction and allow the needle wire 22 / needle 22' and needle wire catheter 26 to pass through. In some embodiments, one or more suction head lumens, channels, and / or open spaces 36 facilitate the transmission of suction pressure within the suction head 12 to the suction opening 32, thereby facilitating suction engagement with the aortic diaphragm 1000.

[0041] In some embodiments, as shown in Figures 8 and 23A to 25, the suction head 12 may have one or more suction lumens or ports 36 for transmitting suction pressure to the suction head 12, which is generated or supplied by a suction source 30 and transmitted through fluid channels in the outer sheath 14. More specifically, in some embodiments, suction is transmitted along the outer sheath lumen 38 to one or more suction head lumens 36.

[0042] In some embodiments, the suction head 12 has one or more guide features 39. In some embodiments, the guide feature 39 may have one or more protrusions and / or undulations within the suction head 12 configured to guide the needle wire 22, needle 22', and / or needle wire catheter 26 to the suction opening 32 and / or the center of the suction head 12. Furthermore, in some embodiments, the guide feature 39 may have a lateral and proximal lateral feature 39' within the suction head 12 configured to restrain the needle wire 22, needle 22', and / or needle wire catheter 26 to the middle of the suction head 12 and to suppress operational constraint within the suction head 12. In some embodiments, an additional feature may be located distally and centrally within the suction head 12. The guide features 39, 39' guide the needle wire 22, needle 22', and / or needle wire catheter 26 downward (away from the suction head 12) and / or centrally (along the longitudinal axis of the suction head 12). This optimizes the needle fenestration by (1) ensuring that the needle wire 22, needle 22', and / or needle wire catheter 26 exit from the center of the suction opening 32 and not from the tip or end of the suction opening 32, thereby preventing loss of suction by detaching the suction head 12 from the aortic diaphragm 1000, and (2) reducing the force required to pass the needle wire 22 / needle 22' through the diaphragmatic tissue by reducing the acute angle at which the needle wire 22 / needle 22' approaches the aortic diaphragm 1000.

[0043] In some embodiments, as shown in Figures 23A to 25, one or more suction head lumens 36 may be formed along guide features 39, 39' to ensure that suction is delivered throughout the entire suction opening 32 when tissue is engaged. For example, in some embodiments that do not have a suitable channel for suction, the tissue may block the most distal portion of the suction opening 32 as it is drawn into the suction opening 32. This may reduce the retaining force between the diaphragm 1000 and the suction opening 32. Therefore, in some embodiments, as shown in Figures 23A to 23B, the suction head lumens 36' can be formed along the space between the central guide feature 39 and each lateral guide feature 39' to ensure that suction passes through there.

[0044] In some embodiments, as shown in Figures 24-25, the suction head lumen 36 can be formed as one or more suction channels 36'' formed through the guide feature 39 and / or a portion of the suction head 12. In this way, even if flexible tissue is drawn into the head orifice, which could hinder suction and consequently reduce the holding force that attaches the device to the tissue, suction can still be passed through the suction channel 36'' from the proximal hole 46 to the distal hole 48, allowing suction to reach the distal end of the suction head 12.

[0045] In some embodiments, as shown in Figure 20, the needle 22' may have an angled distal end or tip 23. In some embodiments, the angled distal end 23 may be angled to define an angled or pointed tip, which is usually formed at an angle inclined with respect to the guide feature 39, thereby facilitating smooth, largely unrestricted extension of the needle 22' from the suction head 12 and efficient penetration of the aortic diaphragm 1000. This works to reduce the extension force and improves the advancement of the needle 22' into the aortic diaphragm 1000. In some embodiments, the angled distal end 23 may define an angle greater than the angle of the guide feature 39, as shown, such that the distal tip of the angled distal end 23 is separated from the guide feature 39.

[0046] As can be seen in Figure 12, the central guide feature 39 serves a further purpose: to guide the flexible diaphragmatic tissue so that the acute angle with respect to the angle of the needle wire 22 / needle 22' is reduced. This reduces the force required for the needle wire 22 / needle 22' to pass through the diaphragmatic tissue.

[0047] In some embodiments, the suction head 12 has a ring-shaped proximal projection 42 on which the outer sheath 14 is placed or captured and fitted inside it. In some embodiments, the ring is wedge-shaped with a thinnest part at the proximal end and a thickest part at the distal end, and is angled to guide the needle toward the center of the suction head 12. In some embodiments, the outer sheath 14 is captured within the ring-shaped projection 42 to minimize edge features that could cause operational constraints on the needle wire 22 / needle 22' during operation.

[0048] In some embodiments, the suction head 12 may include one or more radiopaque markers 15 (Figure 23A). In some embodiments, the radiopaque markers 15 are embedded within the suction head 12 to indicate the position and orientation of the device with respect to two-dimensional fluoroscopy or other X-ray-based imaging. In some embodiments, the radiopaque markers 15 are constructed of a radiopaque material such as tungsten, gold, platinum, or other materials. In some embodiments, the radiopaque markers 15 may consist of two linear markers positioned laterally with respect to the orifice of the suction head 12. In some embodiments, the radiopaque markers 15 are oriented parallel to the suction opening 32 to help the user align the suction head 12 with the tissue surface using fluoroscopy before enabling suction for tissue attachment to the suction head 12, but radiopaque markers of other orientations and configurations may be used.

[0049] [Port with valve] In some embodiments, as shown in Figures 2 and 4, an external valved port may be located at the external / proximal end of the needlewire catheter 26. In some embodiments, an additional valve or port may be located at the proximal end of the outer sheath 14. The valved port accepts the needlewire catheter 26 and can self-seal around the valved port, thereby preventing blood from flowing backward from the device and allowing the needlewire 22, needle 22', and needlewire catheter 26 to pass through smoothly. The valved port may also be included as part of an integrated external manifold, as described herein.

[0050] In some embodiments, as shown in Figure 21, the valve port assembly 50 can be located within the handle 16 at the proximal end of the outer sheath 14. In some embodiments, the valve port assembly 50 may have a distal end 52 which is bonded or otherwise connected to the proximal end of the outer sheath 14 to form a seal 54 between them, thereby maintaining suction within the outer sheath lumen 38. As described herein, the valve port assembly 50 is configured to provide a continuous suction tube or channel between the suction source 30, the outer sheath lumen 38, and the suction head lumen 36.

[0051] [Suction syringe / suction pump] In some embodiments, as shown in Figure 2, the suction source 30 can be connected via a Luer-lock type fitting 20 and configured to provide sufficient suction to attach the suction head 12 to the diaphragm 1000, and in some embodiments, the suction head 12 can be reattached multiple times if it becomes detached or if multiple window positions are desired.

[0052] In some embodiments, the suction source 30 is configured to generate negative pressure. In some embodiments, the Luer-lock fixture 20 and / or the suction source 30 may have a negative pressure gauge. The suction source 30 may be configured to release and regenerate negative pressure multiple times. In some embodiments, the suction source 30 may have an electronic suction pump or syringe including a locking syringe. In some embodiments, the suction source 30 may detect that the suction head 12 has connected to tissue, for example by detecting an increase in vacuum pressure within the catheter, and notify the user that the suction head has been successfully attached. In some embodiments, suction may be generated externally and connected to the device via a suction tube (also called wall suction). In this case, suction regulators may be present in a single line.

[0053] In some embodiments, a manifold can be used to arrange multiple locking syringes in series or parallel, as shown in Figures 18A and 19. In some embodiments, the suction tube is operably coupled to a valve port assembly 50, exits from a handle 16, and is operably coupled to a multi-directional stopcock and / or Luer-lock fitting 20 for connecting a suction source 30. Suction may be performed, for example, by first generating a vacuum in the suction source 30 and then opening the stopcock 20 when the operator is ready to deliver suction at the suction head, but other means of activating suction, such as via a start button, may also be considered.

[0054] Referring further to Figure 19, in some embodiments, the suction source 30 has a manifold 31 and at least one locking syringe 33. The manifold 31 includes one or more stopcocks 35, preferably at the connection point of each locking syringe 33, so that the user can select which vacuum source they want to place in the sheath lumen 38 and the suction head lumen 36. In some embodiments, the locking syringe is one that generates a vacuum by pulling back the plunger, and the user can then lock the plunger in this pulled-back position without holding the syringe. This allows the user to selectively deploy multiple vacuum sources. In some operations, the user may advance the suction head 12 to the tissue or surface where an opening is desired. The user may then proceed to attempt to attach the suction head 12 to the tissue. The user then opens a stopcock 35 of one of the multiple locking syringes 33. However, if the suction head 12 is not positioned correctly and tissue compression is not achieved, instead of resetting the locking syringe to generate more vacuum, the user may instead reposition the suction head 12 and open the stopcock 35 of the next locking syringe 33, allowing for a quicker retry of tissue compression with the suction head 12. This manifold allows the user to generate excess vacuum pressure, which can be utilized as desired to secure the suction head to the desired tissue.

[0055] [Needle wire] In some embodiments, the needle wire 22 may have an elongated wire with an inclined distal end or tip 23, which in some embodiments has a tapered and / or other wire surface so that the user can puncture the diaphragm. The distal end portion of the needle wire 22 may include a pre-curved portion to facilitate handling. The needle wire 22 may be deployable with its distal tip beyond the suction head 12, with a diameter of approximately 0.254 mm to 1.016 mm (approximately 0.010 to 0.040 inches), and may be long enough so that the proximal end is operable by the user. In some embodiments, the needle wire 22 may be made from a material including but not limited to stainless steel and / or nitinol, and may be solid or hollow. The needle wire 22 is further configured to cross the needle wire catheter 26 and the bend in the suction head 12. The needle wire may be configured to accept the passage of a guide wire through its central bore, which is advantageous because the guide wire may be passed directly through the false lumen after the needle window is opened.

[0056] [needle] In some embodiments, the needle 22' may have an elongated hollow needle with an inclined distal end or tip 23, which in some embodiments has a tapered and / or other surface to allow the user to puncture the diaphragm. The distal end portion of the needle 22' may include a pre-curved portion to facilitate operation. The needle 22' can have its distal tip positioned beyond the suction head 12 and have a diameter of about 0.254 mm to 1.778 mm (about 0.010 to 0.070 inches) and be long enough so that the proximal end is operable by the user. In some embodiments, the needle 22' may be made of a material including but not limited to stainless steel and / or nitinol and may be hollow. The needle 22' may traverse or advance through the outer sheath 14 and be further configured to adapt to bending forces. The needle 22' may be configured to accept the passage of the guidewire 28 through its lumen, thereby allowing the guidewire 28 to pass directly into the false lumen after the needle window is opened.

[0057] In some embodiments, as shown in Figures 18A, 19, and 21, a Luer-lock type attachment 21 is provided at the proximal end of the needle 22' to enable the aortic fenestration device 10 to operate without the presence of the guidewire 28 and / or to allow the introduction of the guidewire 28 after fenestration.

[0058] [Needle wire catheter] In some embodiments, the needle wire catheter 26 has a thin-walled hollow catheter that slides over the needle wire 22. In some embodiments, the needle wire catheter 26 is long enough proximal to be operated by the user without buckling, and long enough so that the needle wire 22 can advance at least 1 cm beyond the suction head 12. In some embodiments, the needle wire catheter 26 can be made from a low-friction material to facilitate the operation of the needle wire 22.

[0059] In some embodiments, the needlewire catheter 26 has a proximal portion including a valved port. In some embodiments, the needlewire catheter 26 is configured to accept a standard-sized guidewire 28, including but not limited to 0.3556 mm (0.014 inches), 0.4572 mm (0.018 inches), and / or 0.889 mm (0.035 inches), allowing the guidewire 28 to advance into the false lumen.

[0060] During operation, the needlewire catheter 26 is configured to provide the needlewire 22 with additional rigidity and maneuverability. For this purpose, the needlewire catheter 26 can slide along the needlewire 22 to cross the diaphragm. In some embodiments, the needlewire catheter may include one or more radiopaque markers to help facilitate navigation within the patient. In some embodiments, the needlewire catheter may include a tapered distal tip.

[0061] [Advance mechanism] In some embodiments, an advancement mechanism 24 is provided, which is configured to extend and / or retract the needle wire 22 / needle 22' into and relative to the suction head 12, particularly toward the diaphragm contact surface or the suction opening 32. In some embodiments, the advancement mechanism 24 is configured to actuate and / or position the needle wire 22 / needle 22' into one or more selectively retainable positions. In some embodiments, the advancement mechanism 24 minimizes the penetrating force through the aortic diaphragm 1000 by maintaining the ideal orientation of the needle wire 22 / needle 22' toward the diaphragm wall. In some embodiments, the advancement mechanism 24 is configured to allow the user to advance the needle wire 22 / needle 22' when it is at a separation distance beyond the suction opening 32 of the suction head 12. In some embodiments, the advancement mechanism 24 is configured to allow the user to advance the needle wire catheter 26 to a distance separated from the needle wire 22. In some embodiments, the forward mechanism 24 is configured to allow the user to fully retract and remove the needle wire 22 through the needle wire catheter 26. In some embodiments, the forward mechanism 24 is configured to be maneuverable.

[0062] Referring particularly to Figures 18A to 19 and Figure 21, the forward mechanism or actuator device 24 may have a slider member 62, which is operably bonded or otherwise connected to the needle wire 22 / needle 22' and is slidably positioned with the handle 16 within the slider housing slot 64 and is manually operated between a retracted position (Figure 21) and an extended position. In some embodiments, the slider member 62 can be optionally locked in a predetermined position when not pressed, for example, using a ball spring mechanism, a stepped groove mechanism, etc. That is, by pushing down the slider member 62, the slider member 62 moves freely in parallel with respect to the slider member housing slot 64. The slider member advances the needle in a 1:1 manner. The needle wire 22 / needle 22' is firmly fixed to the slider member 62. The slider member 62 enables continuous forward and backward movement of the needle wire 22 / needle 22'. Next, when the downward pressure on the slider member 62 is removed, its relative movement to the handle 16 is fixed, preventing the needle wire 22 / needle 22' from moving linearly parallel to the handle 16.

[0063] [Guide wire] In some embodiments, the guidewire 28 is a soft-tipped guidewire with a diameter ranging from 0.3556 mm to 0.889 mm (0.014 inches to 0.035 inches), but other sizes may be used. The guidewire 28 may be sized to allow for linear parallel movement within the needlewire catheter 26 or needle 22'.

[0064] [Operation] As shown in the figure, during the operation shown in Figure 11, the aortic fenestration device 10 is advanced into the abdominal aorta and positioned adjacent to the diaphragmatic wall of the aortic diaphragm 1000. As shown in Figures 12 and 27A, suction is activated and attachment to the aortic diaphragm 1000 is confirmed. The aortic fenestration device 10, specifically the suction head 12, may be attached to either the false lumen or the true lumen, depending on the situation. As shown in Figures 13 and 27B, the advancement of the needle wire 22 / needle 22' is guided by the guide feature 39, resulting in a lower acute angle of the puncture angle relative to the aortic diaphragm 1000. The needle wire 22 / needle 22' can be advanced across the aortic diaphragm 1000, and in some embodiments, the needle wire catheter 26 remains housed within the suction head 12.

[0065] As shown in Figure 14, the needle wire 22 can be kept fixed in place, and the needle wire catheter 26 can be advanced along the needle wire 22, penetrating the aortic diaphragm 1000. As shown in Figure 15, the needle wire 22 can then be removed, leaving the needle wire catheter 26 in place within the false lumen. Next, the guide wire 28 can be placed in the second lumen through the needle wire catheter 26 or needle 22', as shown in Figures 16 and 27C. As shown in Figures 17 and 27D, suction can be terminated and the device removed from above the guide wire 28, thereby leaving the guide wire 28 in place, penetrating the aortic diaphragm 1000 with its distal portion within the second lumen. Guide wire access to the false lumen allows the operator to perform a wide range of sophisticated procedures to treat organ perfusion disorders, including dilation and stent placement, as well as septotomy for optimizing the endovascular graft placement area in chronic type B dissection.

[0066] [Alternative concept] In some embodiments, as shown in Figure 28, the suction head 12 may include a pair of bipolar electrodes 90. For example, when the suction head is fixed to tissue, energy may be transferred to the bipolar electrodes. One or more wires may be connected to the electrodes and incorporated into the wall of the outer sheath. The user can then use an external power source connected to the wires to power the electrodes. Once the bipolar function is activated by the user, current flows between the electrodes, cutting the tissue between them, allowing a guide wire to pass through the cut surface. Additional alternative means for cutting or opening tissue engaged in the suction opening may include a unipolar electrode, a harmonic surgical scalpel that cuts tissue using high-frequency vibrations, or other means.

[0067] As shown in Figure 29, an alternative means of biasing the device tip to one side of the vascular lumen is, for example, an air-inflatable member 92 such as a balloon, which may be inflated at the user's discretion via a secondary lumen in the outer sheath to guide or bias the device tip. Alternative means of biasing the tip may include expandable parts, pre-bending of the outer sheath, and thermally responsive bending of the outer sheath.

[0068] As described herein, the principle of this teaching may be used with a laser device 94, such as the one shown in Figure 30, instead of the needle wire 22 / needle 22'. In such embodiments, the needle component is replaced with a catheter-based laser 94, such as a coronary artery laser atherectomy catheter (e.g., Philips ECLA laser). The laser catheter may include an energized tip 96 with a lumen that can receive a guidewire 28. Once the laser is activated at the power source 98, the catheter-based laser can be advanced through the tissue, as shown in the preceding embodiments. The guidewire can then be passed through the lumen of the catheter-based laser and placed into a false lumen or other cavity. The catheter-based laser can be connected to an external power source.

[0069] The above description of embodiments is provided for illustrative and explanatory purposes only. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are not typically limited to that particular embodiment, but are interchangeable and usable in selected embodiments where applicable, even if not specifically illustrated or described. The same may also be modified in many ways. Such modifications should not be considered deviations from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

Claims

1. Outer sheath and, A suction head operably coupled to the distal end of the outer sheath, comprising a suction head having a suction opening, An opening element disposed within the outer sheath, configured to open up tissue, A guide wire is slidably positioned relative to the window opening element and extends beyond the suction opening and the distal end of the window opening element. A suction source operably coupled to the outer sheath and configured to apply suction pressure at the suction opening of the suction head, wherein when the tissue is opened, the suction pressure selectively connects the suction head to the tissue. An aortic fenestration device having an aortic opening.

2. The aortic fenestration device according to claim 1, wherein the fenestration element has a hollow needle.

3. The aortic fenestration device according to claim 2, wherein the hollow needle is slidably disposed within the outer sheath and extendable through the suction head to a position beyond the suction opening.

4. The aortic fenestration device according to claim 3, wherein the guide wire is slidably disposed within the hollow needle and extends through the hollow needle to a position beyond the suction opening and the distal end of the hollow needle.

5. The aforementioned window opening element is A needle wire catheter is slidably disposed within the outer sheath and extends through the suction head to a position beyond the suction opening, A needle wire is slidably disposed within the needle wire catheter and extends through the needle wire catheter to a position beyond the suction opening and the distal end of the needle wire catheter. An aortic fenestration device according to claim 1, comprising:

6. The aortic fenestration device according to claim 1, further comprising a forward mechanism configured to extend or retract a fenestration element relative to the suction opening of the suction head.

7. The aortic fenestration device according to claim 6, wherein the forward movement mechanism is configured to actuate or position one or more fenestration elements to selectively hold positions.

8. The aortic fenestration device according to claim 1, wherein the outer sheath is configured to articulate around its longitudinal axis.

9. The aortic fenestration device according to claim 8, wherein the outer sheath articulates in response to contact with a guide feature formed within the suction head.

10. An outer sheath articulation assembly configured to actively articulate the outer sheath about the longitudinal axis, further comprising a drive member for operably operating one or more wire members arranged along the length of the outer sheath, and configured to apply a bending force to at least one area of ​​the outer sheath in response to the movement of the drive member, according to claim 8.

11. The aortic fenestration device according to claim 10, wherein the outer sheath joint movement assembly is configured to apply a bending force within the outer sheath, thereby causing joint movement of the suction head in the direction of the suction opening.

12. The suction head has a suction head lumen that is fluidly coupled to the suction opening, The aortic fenestration device according to claim 1, wherein the suction source is configured to apply suction pressure to the suction opening of the suction head via the lumen of the suction head.

13. The aortic fenestration device according to claim 1, wherein the suction head has one or more guide features inside that are configured to guide the fenestration element to the center of the suction opening.

14. The aortic fenestration device according to claim 13, wherein one or more of the guide feature portions have an inclined surface.

15. The aortic fenestration device according to claim 13, wherein one or more guide feature portions have a central inclined surface and at least one pair of lateral inclined surfaces.

16. The aortic fenestration device according to claim 15, further comprising a suction head lumen formed between the central inclined surface and at least one of the at least pair of lateral inclined surfaces.

17. The aortic fenestration device according to claim 15, further comprising a suction head lumen formed as a channel extending through the central inclined surface.

18. The aortic fenestration device according to claim 1, further comprising a valve port assembly operably coupled between the suction source and the outer sheath.

19. The aortic fenestration device according to claim 1, wherein the suction source has a manifold fluidly coupled to at least one lockable syringe.

20. The aortic fenestration device according to claim 1, wherein the fenestration element is extendable through the suction head to a position beyond the suction opening.

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