Method and apparatus for forming centered arterial incision through conduit

Abstract

Various embodiments and related methods of an arterial incision formation system are disclosed. The arterial incision formation system may include a central puncture device and an arterial incision formation device. The central puncture device may include a puncture element that forms a puncture hole along a wall of the first blood vessel at a central location of a conduit passage of the conduit. An arterial incision forming device may include a tissue fixation element, a tissue capture element, and a tissue cutting element. The arterial incision forming device may form an arterial incision along the first vessel such that the arterial incision is centered relative to the conduit passage.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Pursuant to 35 U.S.C. §119(e), this application claims priority to U.S. Provisional Patent Application Serial No. 63 / 388,513, filed on July 12, 2022, entitled “Methods and Apparatus for Forming a Centered Arterial Incision Through a Tube,” which is incorporated herein by reference in its entirety. Background Art

[0003] When the stapler is attached to a vessel, the vessel may be clamped distally and proximally of the intended access site into the vessel. Such clamping may cause blood flow to be completely stopped for the length of time required (e.g., approximately 10 minutes to 35 minutes) to attach the tubing to the vessel, such as at the intended access site. This may result in the possibility of vessel injury, vessel dissection, and patient discomfort. For patients with impaired collateral circulation, complete blood flow cessation may be unbearable.

[0004] In addition, if the arteriotomy is formed before the attachment of the stapler, the arteriotomy may not be centered on the internal diameter of the stapler. Due to the friction with the arteriotomy, the destruction of the stapler and / or the expansion of the stapler outside the anastomosis suture line, this may cause the tracking of the device to be poor. In addition, it may be challenging to safely and effectively form an arteriotomy along a blood vessel via the attached stapler. Therefore, it is desirable to overcome the method and apparatus for the problem of arteriotomy and anastomosis-related surgery. Summary of the invention

[0005] Aspects of the inventive subject matter described herein relate to embodiments of arteriotomy systems and related methods. In one aspect, an arteriotomy system is described that includes a central puncture device. The central puncture device may include an elongated cylindrical body having an outer wall that slidably engages an inner wall of a conduit of a conduit that is matched to a first blood vessel. The elongated cylindrical body may include a central passage that extends along the longitudinal axis of the elongated cylindrical body. The central puncture device may also include a puncture element that is movable along the central passage. The puncture element may be movable between a retracted configuration and an extended configuration, and when in the retracted configuration, the distal end of the puncture element may be located within the central passage. When in the extended configuration, the distal end of the puncture element may extend from the elongated cylindrical body; and the puncture element may extend along the longitudinal axis of the elongated cylindrical body, thereby allowing a puncture to be formed along the wall of the first blood vessel at a central location of the conduit passage of the conduit.

[0006] The arteriotomy system may also include an arteriotomy device, the arteriotomy device including a tissue fixation element, the tissue fixation element including an elongated body having a fixed passage extending along the length of the tissue fixation element. The arteriotomy device may also include a tissue capture element configured to form a first configuration having a first outer diameter and a second configuration having a second outer diameter, the second outer diameter being greater than the first outer diameter. The first configuration may allow the capture element to pass through the puncture, and the second configuration may allow the tissue capture element to capture tissue excised from the wall of the first blood vessel. The arteriotomy device may also include a tissue cutting element that is movable relative to the tissue fixation element and the tissue capture element to form an arteriotomy along the wall of the first blood vessel, and the tissue cutting element may include an outer cutting wall that is slidably engaged with the conduit inner wall of the conduit and forms the arteriotomy along the first blood vessel so that the arteriotomy is centered relative to the conduit passage.

[0007] In some variations, one or more of the following features may optionally be included in any feasible combination. The tissue capture element may include an inflatable balloon. The inflatable balloon may be disc-shaped in a second configuration. The first outer diameter may be less than the diameter of the puncture. The tissue cutting element may include a radio frequency (RF) electrode. The tissue cutting element may include a distal probe configured to perform electrocautery. The tissue cutting element may include at least one extendable blade. The elongated cylindrical body may include a beveled distal end. The conduit may include a sheath or a second blood vessel. The puncture element may include a removable guide wire extending therethrough. The capture element may be configured to slidably travel along the guide wire.

[0008] In another related aspect of the present subject matter, a method of an arteriotomy system may include forming a puncture along a wall of a first blood vessel of a patient. The puncture may be formed at a central location of a conduit passage of a conduit by a central puncture device of the arteriotomy system. The central puncture device may include an elongated cylindrical body including an outer wall that slidably engages a conduit inner wall of a conduit that is matched to the first blood vessel, and the elongated cylindrical body may include a central passage that extends along a longitudinal axis of the elongated cylindrical body. The central puncture device may include a puncture element that is movable along the central passage, and the puncture element may be movable between a retracted configuration and an extended configuration. When in the retracted configuration, a distal end of the puncture element may be located within the central passage; and when in the extended configuration, a distal end of the puncture element may extend from the elongated cylindrical body. The puncture element may extend along the longitudinal axis of the elongated cylindrical body, thereby allowing a puncture to be formed along the wall of the first blood vessel at a central location of the conduit passage of the conduit.

[0009] The method may also include forming an arteriotomy along the wall of the first blood vessel. The arteriotomy may be formed by an arteriotomy forming device at a position centered relative to the conduit passage of the conduit. The arteriotomy forming device may include a tissue fixation element and a tissue capture element; the tissue fixation element includes an elongated body having a fixation passage extending along the length of the tissue fixation element; the tissue capture element is configured to form a first configuration having a first outer diameter and a second configuration having a second outer diameter, the second outer diameter being greater than the first outer diameter. The first configuration may allow the capture element to pass through the puncture, and the second configuration may allow the tissue capture element to capture tissue excised from the wall of the first blood vessel. The arteriotomy forming device may include a tissue cutting element that is movable relative to the tissue fixation element and the tissue capture element to form the arteriotomy along the wall of the first blood vessel, and the tissue cutting element may include an outer cutting wall that slidably engages the conduit inner wall of the conduit and forms the arteriotomy along the first blood vessel such that the arteriotomy is centered relative to the conduit passage.

[0010] In some variations, one or more of the following features may optionally be included in any feasible combination. The method may also include capturing tissue removed from the wall of a first blood vessel with a tissue capture element and removing the captured tissue from the patient. The tissue capture element may include an inflatable balloon. The inflatable balloon may be disc-shaped in a second configuration. The first outer diameter may be less than the diameter of the puncture. The tissue cutting element may include a radio frequency (RF) electrode. The tissue cutting element may include a distal probe configured to perform electrocautery. The tissue cutting element may include at least one extendable blade. The elongated cylindrical body may include an inclined distal end. The conduit may include a sheath or a second blood vessel. The puncture element may include a removable guide wire extending therethrough. The capture element may be configured to slidably travel along the guide wire.

[0011] The details of one or more variations of the subject matter described herein are set forth in the following drawings and detailed description.Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] To further illustrate the above and other advantages and features of the present invention, a more specific description of the present invention will be presented by reference to its specific embodiments shown in the accompanying drawings. It should be understood that these drawings only show illustrated embodiments of the present invention and therefore should not be considered to limit its scope. By using the accompanying drawings, the present invention will be described and explained with additional specificity and detail, in which:

[0013] Figure 1 A side view of one embodiment of a central puncture device of an arteriotomy system is shown.

[0014] Figure 2AA side cross-sectional view of a portion of an example arteriotomy procedure is shown including a tube attached to a blood vessel.

[0015] Figure 2B A side cross-sectional view showing a portion of an example arteriotomy procedure, including a Figure 1 The distal portion of the central puncture device.

[0016] Figure 2C A side cross-sectional view showing an example portion of an arteriotomy procedure, including forming a puncture along a blood vessel wall. Figure 1 The puncture element of the central puncture device.

[0017] Figure 3A A partial cross-sectional view of one embodiment of an arteriotomy device of an arteriotomy system is shown, showing the balloon of the tissue capture element in a collapsed configuration.

[0018] Figure 3B Show Figure 3A A partial side cross-sectional view of a median arteriotomy device showing the balloon in an inflated configuration.

[0019] Figure 4A A side cross-sectional view of a portion of an example arteriotomy procedure showing a Figure 3A The distal portion of the arteriotomy device is placed in a deflated configuration through the puncture.

[0020] Figure 4B A side cross-sectional view of a portion of an example arteriotomy procedure showing a Figure 3A The distal portion of the arteriotomy device and the balloon in the inflated configuration.

[0021] Figure 4C A side cross-sectional view of a portion of an example arteriotomy procedure showing a Figure 3A The distal portion of the arteriotomy device is formed and the tissue cutting element is advanced through the vessel wall toward the inflated balloon.

[0022] Figure 4D A side cross-sectional view of a portion of an example arteriotomy procedure is shown, illustrating the arteriotomy along a blood vessel wall.

[0023] Figure 5 A partial side cross-sectional view of one embodiment of an arteriotomy device is shown positioned within a conduit not attached to a blood vessel.

[0024] Figure 6 Another embodiment of a tissue cutting element comprising a radio frequency (RF) electrode is shown.

[0025] Figure 7Another embodiment of a tissue cutting element including a distal probe for performing cautery is shown.

[0026] Figure 8 One embodiment of a tissue fixation element is shown that includes another embodiment of a tissue cutting element that includes an extendable blade element.

[0027] Where practical, the same or similar reference numerals represent the same or similar or equivalent structures, features, aspects or elements according to one or more embodiments. DETAILED DESCRIPTION

[0028] The disclosed methods, apparatus, and systems relate to efficiently and effectively forming an arteriotomy, such as during anastomosis-related surgery. For example, the present invention discloses various embodiments of an arteriotomy forming system, which includes a central puncture device and an arteriotomy forming device. The central puncture device can assist in extending along a conduit and forming a puncture along a vessel wall, which is approximately centered relative to the passage of the conduit. For example, the arteriotomy forming device can use the centered puncture formed by the central puncture device to form a centered arteriotomy relative to the passage of the conduit (e.g., a vessel wall opening that is enlarged compared to the puncture). The arteriotomy forming system can efficiently and consistently form a centered arteriotomy of known and desired size (e.g., relative to adjacent conduits). Therefore, the arteriotomy forming system can minimize the risk of bleeding and tissue damage, maximize the ease of device tracking (e.g., due to reduced friction with tissue surrounding the arteriotomy), and maximize the diversion capacity to minimize embolic events. Other benefits associated with the arteriotomy forming system may include the ability to minimize or prevent damage to the formed anastomosis due to a properly sized and centered stapler, such as preventing enlargement of the arteriotomy beyond the anastomotic suture line.

[0029] In addition, the arteriotomy system embodiments disclosed herein can form an arteriotomy after attachment of a stapler or tubing. This can at least reduce the amount of time required to completely stop blood flow in one or more parts of the body, thereby reducing potential vascular damage and / or allowing patients with impaired circulation to undergo anastomosis surgery.

[0030] In some embodiments, the arteriotomy system, including the central puncture device and the size of the arteriotomy device can be set to assist in performing arteriotomies associated with a variety of procedures, including anastomosis procedures associated with various parts of the body. Thus, without departing from the scope of the present disclosure, the arteriotomy system can be used with a variety of vessels, including the common femoral artery, subclavian artery, carotid artery, jugular vein, inferior vena cava, aorta, apex of the left or right ventricle, etc. In addition, the arteriotomy system can be used with one or more of a variety of access systems and sheaths.

[0031] Described below are various embodiments of arteriotomy systems including a central puncture device and an arteriotomy device, and related methods of use in example arteriotomy and anastomosis procedures.

[0032] Figure 1 One embodiment of a central puncture device 102 of an arteriotomy formation system 100 is shown. The central puncture device 102 can be configured to be inserted into the proximal end of a conduit, such as a conduit connected to a vessel wall. For example, the central puncture device 102 can extend along the length of a conduit passage of the conduit and form a puncture through the vessel wall. The formed puncture can extend generally along the longitudinal axis of the central puncture device and the conduit. As will be disclosed in more detail below, the centered puncture can provide guidance for efficiently and effectively forming an arteriotomy of a desired shape and size along the vessel wall, which is centrally aligned with the conduit passage.

[0033] like Figure 1 As shown, the central piercing device 102 may include an elongated cylindrical body 105 extending from a coupling end 106 of the central piercing device 102. For example, the elongated cylindrical body 105 may include an outer wall 107 having a diameter that is the same as or slightly smaller than the diameter of the inner wall of the pipe (e.g., a diameter that is approximately 1 mm smaller), and the elongated cylindrical body 105 may extend along the pipe to form a puncture. For example, the outer wall 107 of the elongated cylindrical body 105 may have a diameter that allows the outer wall 107 to generally have a sliding fit or sliding engagement with the inner wall of the pipe. The sliding fit between the outer wall 107 of the elongated cylindrical body 105 and the inner wall of the pipe may allow the elongated cylindrical body 105 to travel along the pipe, such as to position the distal end of the elongated cylindrical body 105 at or adjacent to the distal end of the pipe, while also centering the elongated cylindrical body 105 relative to the pipe. By centering the elongated cylindrical body 105 relative to the tract, the central puncture device 102 can efficiently and effectively form a puncture through the vessel wall at a location approximately at the center point of the distal opening of the tract.

[0034] like Figure 1 As shown, the elongated cylindrical body 105 may include a central passage 108 including a passage longitudinal axis that is co-linear with the longitudinal axis of the elongated cylindrical body 105. Thus, the central passage 108 extends centrally along the elongated cylindrical body 105, as shown in FIG. Figure 1As shown. The central puncture device 102 may also include a puncture element 110 that can move along the central passage 108. The puncture element 110 may have an elongated puncture body 111, wherein the distal end 112 is sharp and / or inclined for puncturing tissue, such as puncturing a blood vessel wall. The elongated puncture body 111 may have an outer diameter that is smaller than the inner wall 109 of the central passage 108. In some embodiments, the puncture element 110 may form a sliding fit (e.g., a sliding engagement) with the inner wall 109 of the central passage 108, thereby centering the puncture element 110 relative to the elongated cylindrical body 105.

[0035] The puncture element 110 can be moved between a retracted configuration and an extended configuration. In the retracted configuration, the distal end 112 of the puncture element 110 can be located within the central passage 108. In the extended configuration, the distal end 112 of the puncture element 110 can extend out of the elongated cylindrical body 105, such as to form a central puncture relative to the central passage.

[0036] In some embodiments, the distal end 114 of the elongated cylindrical body 105 includes a distal surface 113 that is positioned at an angle relative to the longitudinal axis of the elongated cylindrical body 105, thereby forming an inclined or slanted shape at the distal end 114 of the elongated cylindrical body 105. The inclined or slanted shape can allow the distal surface 113 of the puncture element 110 to substantially contact the vessel wall and align with the elongated cylindrical body 105 at an angle relative to the vessel wall, such as at the same or similar angle that the tube extends (relative to the matching blood vessel). Other shapes and features may be included at the distal end 114 of the elongated cylindrical body 105, such as a distal surface 113 that is perpendicular to the longitudinal axis of the elongated cylindrical body 105, without departing from the scope of the present disclosure. For example, the elongated cylindrical body 105 may have an outer wall diameter that is approximately the same as the diameter of the tube (e.g., Figure 2B The elongated columnar body 105 may be approximately the same as or approximately 1 mm smaller than the pipe 120 of the embodiment of the present invention, along which the elongated columnar body 105 extends. In some embodiments, the elongated columnar body 105 may have a length of approximately 5 cm to approximately 35 cm, which may depend on the length of the pipe.

[0037] In some embodiments, the coupling end 106 may include at least one valve 115 to control a fluid line that may be in communication with the central puncture device. For example, the valve 115 may include one or more of a hemostatic valve, a rotary hemostatic valve (RHV), a Tuohy Borst valve, a Luer lock, and / or other similar valves. Figure 1As shown, the coupling end 106 may include an extension 116 that provides a working passage and / or controls the movement of the puncture element 110 along the central passage 108. For example, the extension 116 may be advanced distally to move the puncture element 110 to an extended configuration and may be retracted proximally to move the puncture element 110 to a retracted configuration. Other features and couplings may be included in the coupling end 106 of the central puncture device 102 without departing from the scope of the present disclosure.

[0038] Figure 2A 2D shows a portion of an example arteriotomy procedure utilizing central puncture device 102. Figure 2A As shown, the conduit 120 can be attached to the wall W of the blood vessel V, such as the distal conduit end 122 of the conduit 120 can be sutured to the wall W of the blood vessel V. For example, the conduit 120 can be another blood vessel (e.g., formed of tissue). In some embodiments, the conduit 120 can be a sheath and / or can be formed of one or more of a variety of materials, including biocompatible materials. Figure 2A As shown, the distal tube end 122 of the tube 120 can be securely attached to the blood vessel V, such as with a suture. In some embodiments, the tube 120 may not be attached to the blood vessel V; instead, the distal tube end 122 may be positioned against or adjacent to the blood vessel V. Figure 2A As shown, the duct 120 may include a duct passage 124 and a duct inner wall 125 defining the duct passage 124 .

[0039] After the distal tube end 122 is positioned and / or secured at a desired location along the wall W of the blood vessel V, the elongated cylindrical body 105 of the central puncture device 102 can be inserted into the tube passage 124 and advanced along it. Figure 2B As shown, the distal end 114 of the elongated cylindrical body 105 can be advanced along the conduit 120 until the distal surface 113 contacts and / or is adjacent to the wall W of the blood vessel V. The distal surface 113 can be at an angle relative to the longitudinal axis of the elongated cylindrical body 105, so that the elongated cylindrical body 105 can extend along the length of the conduit 120, which is coupled to the blood vessel V at a certain angle, while allowing the distal surface 113 to be aligned substantially parallel to the blood vessel wall W. This can allow the distal end 112 of the puncture element 110 to be efficiently and effectively aligned with the longitudinal axis of the conduit 120 and form a puncture 131 through the blood vessel wall along the longitudinal axis of the conduit 120, as shown. Figure 2C shown.

[0040] In some embodiments, the distal opening 126 of the tube 120 can be defined by the tube inner wall 122 at or along the distal tube end 122. Figure 2CAs shown, the distal opening may define a vessel wall region 127 along the wall W of the blood vessel V, which is in communication with the tubing passage 124. Thus, in some embodiments, the vessel wall region 127 may be defined by the distal tubing end 122. To reduce friction and damage to the wall W of the blood vessel V, a puncture and / or arteriotomy may be formed at the center of the distal opening 126 of the tubing 120.

[0041] like Figure 2C As shown, after the distal end 112 of the puncture element 110 passes through the wall W of the blood vessel V, the guide wire 119 can extend from the distal end 112 of the puncture element 110. After the puncture 131 is formed through the wall W of the blood vessel V, the central puncture device 102 can be removed from the conduit 120. In some embodiments, the guide wire 119 is left extending through the puncture 131 to assist in guiding one or more features of an embodiment of the arteriotomy formation device to the location of the puncture 131, such as for forming an arteriotomy.

[0042] Figure 3A and Figure 3B One embodiment of an arteriotomy forming device 150 of an arteriotomy forming system 100 for forming an arteriotomy that is centered relative to a conduit (e.g., a stapler), which can at least ensure device tracking, tissue damage, and reduction of damage caused by thrombus.

[0043] like Figure 3A and Figure 3B As shown, arteriotomy formation device 150 may include a tissue fixation element 152 configured to contact a portion of a vessel wall (e.g., vessel wall region 127). In some embodiments, tissue fixation element 152 may have an elongated tubular shape and may be formed of a material having sufficient rigidity to allow tissue fixation element 152 to apply force against vessel wall region 127. Figure 3A As shown, the tissue fixation element 152 can extend from one embodiment of the coupling end 206 of the arteriotomy forming device 150. The coupling end 206 of the arteriotomy forming device 150 can include the above-mentioned Figure 1 In some embodiments, the tissue fixation element 152 can be moved along the longitudinal axis of the arteriotomy device 150, such as relative to a portion of the coupling end 106. For example, the tissue fixation element 152 can be made of a metal or plastic material, such as one or more of stainless steel and a biocompatible material.

[0044] like Figure 3A and Figure 3BAs shown, the arteriotomy forming device 150 may also include a tissue cutting element 154, which includes a distal cutting end 155 configured to cut the wall of a blood vessel to form an arteriotomy. For example, the tissue cutting element 154 may have an elongated tubular body having a sharp and / or angled distal cutting end 155. In some embodiments, the tissue cutting element 154 can move along the longitudinal axis of the arteriotomy forming device 150, such as relative to a portion of the coupling end 206 and / or the tissue fixation element 152. Figure 3A As shown, the tissue cutting element 154 can have an inner path 156 having a larger diameter than the tissue fixation element 152 such that the tissue fixation element 152 is positioned along the inner path 156 .

[0045] In some embodiments, the distal cutting end 155 of the tissue cutting element 154 may have a circular shape, thereby forming a circular shaped arteriotomy along the vessel wall. Other shapes of the distal cutting end 155 are also within the scope of the present disclosure. In some embodiments, the tissue cutting element 154 may include an outer cutting wall 157 having a diameter smaller than the diameter of the conduit along which the tissue cutting element 154 will extend. For example, the outer cutting wall 157 may have a diameter that is smaller than the diameter of the inner conduit wall (such as, for example, Figure 2A The inner conduit wall 125 shown in the figure can be slidably matched or slidably engaged with each other, thereby at least allowing the tissue cutting element 154 to be positioned at the center of the surrounding conduit. This can allow the elements (such as tissue fixing elements 152) located within the tissue cutting element 154 to also be located at the center of the surrounding conduit.

[0046] For example, tissue cutting element 154 can be made of metal or plastic material, such as one or more of stainless steel and biocompatible material. The size of tissue cutting element 154 can depend on the size of the pipe used in the operation. For example, in some embodiments, tissue cutting element 154 can have an outer diameter of about 3 mm to about 10 mm. In some embodiments, tissue cutting element 154 can have an inner diameter of about 2.5 mm to about 9.5 mm.

[0047] like Figure 3A As shown, the tissue fixation element 152 may include a fixation pathway 158 that allows the capture element 160 to extend along it. In some embodiments, the capture element 160 may include a balloon catheter 161 having an inflatable balloon 162, and the inflatable balloon 162 is positioned adjacent to the distal end of the balloon catheter 161. For example, the balloon catheter 161 may include a fluid line that allows a fluid source to communicate with the coupling end 206 to provide a fluid (e.g., air) to inflate the balloon 162 to form an inflated configuration, such as Figure 3B For example, the inflatable balloon 162 may have a disc shape, such as Figure 3BHowever, other shapes are also within the scope of the present disclosure. In addition, the fluid line along the balloon catheter 161 can allow fluid to be removed from the balloon 162 to deflate the balloon 162 to form a collapsed configuration, such as Figure 3A shown.

[0048] In some embodiments, the capture element 160 can be moved along the longitudinal axis of the arteriotomy device 150, such as relative to a portion of the coupling end 206 and / or the tissue fixation element 152. The capture element 160 may include a variety of shapes and sizes. For example, the size of the balloon 162 can be set based on the size of the tissue cutting element 154. In some embodiments, the balloon 162 can have a diameter of about 3 mm to about 10 mm (when inflated). In some embodiments, the balloon catheter 161 can have an outer diameter of about 0.035 inches to about 0.040 inches. For example, the capture element 160 can be made of one or more of an elastic material, a plastic material, a polyurethane, a silicone, and a biocompatible material. Although the capture element 160 is described as having an inflatable balloon 162, the capture element 160 may include one or more of a variety of features for assisting in capturing tissue.

[0049] In some embodiments, the balloon catheter 161 of the capture element 160 may have an outer diameter that is less than the diameter of the inner fixation wall 159 that defines the fixation pathway 158 of the tissue fixation element 152. For example, the outer diameter of the balloon catheter 161 may be sized such that the balloon catheter 161 has a generally sliding fit with the inner fixation wall 159 of the tissue fixation element 152. Thus, the tissue fixation element 152 may assist in guiding the balloon 162 and the distal end of the balloon catheter 161 along the longitudinal axis of the tissue cutting element 154 and the surrounding tract, thereby allowing the distal end of the balloon catheter 161 and the balloon 162 to pass through the puncture 131 made along the vessel wall for forming an arteriotomy centered at the distal opening 126 of the tract 120. In some embodiments, the balloon catheter 161 may include a guidewire path that allows the balloon catheter 161 to slidably travel along a guidewire, such as the guidewire 119 extending through the puncture 131.

[0050] FIG. 4A to FIG. 4D A portion of an example arteriotomy procedure utilizing an arteriotomy forming device 150 is shown, such as for forming an arteriotomy centered at the distal opening 126 of a conduit 120. Figure 4AAs shown, the distal portion of the arteriotomy device 150 can be inserted into the conduit 120 and extend along the length thereof. For example, the arteriotomy device 150 can be advanced along the conduit path 124 (e.g., along the guidewire 119) until the distal end of the arteriotomy device 150 is located at or near the wall W of the blood vessel V. For example, the distal fixation end 151 of the tissue fixation element 152 and / or the distal cutting end 155 of the tissue cutting element 154 can be placed in contact with and / or adjacent to the wall W of the blood vessel V, such as along the blood vessel wall region 127. After the distal end of the arteriotomy device 150 is positioned at or near the wall of the blood vessel, the capture element 160 can be advanced distally so that the balloon 162 (in a deflated configuration) can be advanced through the puncture 131 (e.g., via the guidewire 119), as shown. Figure 4A As disclosed above, a puncture 131 through the wall W of the blood vessel V may be formed by the central puncture device 102 and is located approximately at the center point of the vessel wall region 127 and / or the distal opening 126 of the conduit 120 .

[0051] like Figure 4B As shown, balloon 162 can be filled with fluid (e.g., via a fluid path along balloon catheter 161) and transformed into an inflated configuration. After balloon 162 is in the inflated configuration, capture element 160 can be advanced proximally until balloon 162 contacts the vessel wall W, as shown in FIG. Figure 4B In this configuration, at least a portion of the vessel wall region 127 is positioned between the balloon 162 and the tissue cutting element 154 and between the balloon 162 and the tissue fixation element 152. This can allow the balloon 162 and the tissue fixation element 152 to maintain cutting of the vessel wall tissue during the formation of the arteriotomy by the tissue cutting element 154.

[0052] like Figure 4C As shown, the distal cutting end 155 of the tissue cutting element 154 can be advanced through the vessel wall W to cut at least a portion of the vessel wall region 127. The tissue cutting element 154 can be advanced toward the balloon 162 until the distal cutting end 155 is at or adjacent to the balloon 162. The cut portion of the vessel wall region 127 can be captured between the balloon 162 and the tissue fixation element 152, and surrounded by the tissue cutting element 154. Thus, the arteriotomy forming device 150 can be retracted and removed from the conduit 120 (including the cut portion of the vessel wall region 127), thereby preventing an undesirable embolic event. Figure 4D As shown, an arteriotomy 170 can be formed along the vessel wall W, and the cut portion of the vessel wall region 127 can be removed by the arteriotomy forming device 150. In addition, as shown in FIG. Figure 4D As shown, the formed arteriotomy 170 can be centered relative to the conduit 120 (eg, the center of the arteriotomy can be located generally along the longitudinal conduit axis Lc of the conduit).

[0053] Other embodiments of arteriotomy system 100 including central puncture device 102 and arteriotomy device 150 and related methods are also within the scope of the present disclosure, and some are described in more detail below.

[0054] Figure 5 One embodiment of an arteriotomy device 150 is shown positioned within a conduit 120 that is not attached to a blood vessel V, such as described above with respect to Figure 3A and Figure 3B An arteriotomy device 150 is described. For example, the conduit 120 (eg, sheath, trocar) can be made of metal and / or a synthetic material, such as plastic and / or a biocompatible material.

[0055] Figure 6 Another embodiment of a tissue cutting element 254 of the arteriotomy device 150 is shown. Figure 6 The tissue cutting element 254 shown can utilize radio frequency (RF) to cut tissue. For example, the tissue cutting element 254 can include an RF electrode 261 at or adjacent to one embodiment of a distal cutting end 260 of the tissue cutting element 254. Figure 6 As shown, the RF electrode can have a circular shape that can form a circular arteriotomy along the vessel wall. RF electrodes of other shapes (such as oval or elliptical RF electrodes) are also within the scope of the present disclosure. During use, the RF electrode 261 of the tissue cutting element 254 can be advanced distally toward and / or through the vessel wall while delivering RF energy to the vessel wall to form an arteriotomy along the vessel wall.

[0056] Figure 7 Another embodiment of a tissue cutting element 354 of the arteriotomy device 150 is shown. Figure 7 The tissue cutting element 354 shown may utilize electrocautery to cut tissue. For example, the tissue cutting element 254 may include a distal probe 370 that provides an electrical current to burn or destroy tissue (such as blood vessel wall tissue) to form an arteriotomy. Figure 7 As shown, the distal probe 370 may have a conical or tapered shape that can form a circular arteriotomy along the vessel wall. Other shapes of the distal probe 370 (such as an oval or elliptical distal probe 370) are also within the scope of the present disclosure. During use, the distal probe 370 of the tissue cutting element 254 may include an electric current and may be advanced distally toward and / or through the vessel wall. In some embodiments, the distal probe 370 may cauterize and destroy the vessel wall tissue to form an arteriotomy, but no tissue cutting piece is formed to be removed. Therefore, some embodiments of the arteriotomy forming device 150 may not include the capture element 160, such as when the tissue cutting element 354 utilizes electrocautery to form an arteriotomy.

[0057] Figure 8Another embodiment of a tissue cutting element 454 of the arteriotomy device 150 is shown. Figure 8 The tissue cutting element 454 shown may include one or more extendable blades 482 that can form an arteriotomy in the blood vessel wall. The extendable blade can be positioned along the cannula needle 484, forming a collapsed configuration when passing through the blood vessel wall (e.g., via the puncture 131), and forming an extended configuration when forming the arteriotomy. The extendable blade 482 can extend radially and / or taper away from the cannula needle 484 so that the arteriotomy is formed without removing the blood vessel wall tissue. Therefore, some embodiments of the arteriotomy forming device 150 may not include the capture element 160, such as when the tissue cutting element 454 with the extendable blade 482 is used to form the arteriotomy. In some embodiments, as the tissue cutting element 454 pushes through the blood vessel wall, one or more extendable blades 482 are spring loaded and retracted. In some embodiments, one or more extendable blades 482 are actively controlled (such as by a user) to selectively form a collapsed configuration and an extended configuration.

[0058] The various sizes of the arteriotomy system 100, such as the central puncture device 102 and / or the arteriotomy device 150, can be modified and customized to size any portion of the arteriotomy system 100 for one or more procedures, such as anastomosis and / or arteriotomy procedures associated with one or more of a variety of vessels and / or conduits. Thus, the arteriotomy system 100, including the central puncture device 102 and / or the arteriotomy device 150, can be modified and customized to have outer and inner dimensions to safely and effectively perform a procedure in one or more of a variety of vessels and conduits.

[0059] During any part of an operation involving the use of an arteriotomy system 100 (such as a central puncture device 102 and / or an arteriotomy device 150), the blood vessel V may be blocked at one or more locations, such as near the location where the arteriotomy 170 is formed. For example, a manual blockage of the blood vessel V at the blocked location may be provided by a clinician from the outside of the blood vessel V using a vascular clamp, such as a Rummel tourniquet or a vascular ring positioned adjacent to the sheath insertion site. The blockage of the blood vessel V may form a closed segment of the blood vessel, thereby preventing blood from flowing along the closed segment. Once the blood vessel V has been treated by the operator, the vascular clamp may be released, thereby allowing recovery of blood flow. One or more of a variety of methods may be used to block the blood vessel V during surgery, but without departing from the scope of the present disclosure.

[0060] Although these descriptions include many details, these details should not be construed as limitations on the scope of the invention or its claimed content, but rather should be construed as descriptions of features specific to a particular embodiment. Certain features described in the context of a single embodiment of this specification may also be implemented in a single embodiment in combination. On the contrary, the various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. In addition, although features may be described above as acting in certain combinations, or even initially claimed as such, in some cases, one or more features of the claimed combination may be deleted from the combination, and the claimed combination may involve a sub-combination or a sub-combination variation. Similarly, although operations are described in the accompanying drawings in a particular order, this should not be construed as requiring such materials to be performed in the particular order shown or in a sequential order or that all operations shown should be performed to achieve the desired result.

[0061] Although various method and apparatus embodiments are described herein with respect to specific versions, it should be understood that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore, the spirit and scope of the appended claims are not limited to the description of the embodiments contained herein.

Claims

1. An arteriotomy system, comprising: Central puncture device, comprising: an elongated cylindrical body including an outer wall slidably engaged with an inner wall of a conduit mated to a first blood vessel, the elongated cylindrical body including a central passage extending along a longitudinal axis of the elongated cylindrical body; and a puncture element movable along the central passage, the puncture element movable between a retracted configuration, wherein a distal end of the puncture element is located within the central passage, and an extended configuration, wherein the distal end of the puncture element extends from the elongated columnar body, and wherein the puncture element extends along the longitudinal axis of the elongated columnar body, thereby allowing a puncture to be formed along the wall of the first blood vessel at a central location of the conduit passage of the conduit; and An arteriotomy device, comprising: a tissue fixation element comprising an elongated body having a fixation passage extending along a length of the tissue fixation element; a tissue capture element configured to form a first configuration having a first outer diameter and a second configuration having a second outer diameter, the second outer diameter being greater than the first outer diameter, the first configuration allowing the capture element to pass through the puncture and the second configuration allowing the tissue capture element to capture tissue excised from the wall of the first blood vessel; and A tissue cutting element movable relative to the tissue fixation element and the tissue capture element to form an arteriotomy along the wall of the first blood vessel, the tissue cutting element comprising an outer cutting wall that slidably engages an inner conduit wall of the conduit and forms an arteriotomy along the first blood vessel such that the arteriotomy is centered relative to the conduit passage.

2. The arteriotomy system of claim 1, wherein the tissue capture element comprises an inflatable balloon.

3. The arteriotomy system of claim 2, wherein the inflatable balloon forms a disc shape in the second configuration.

4. The arteriotomy system of claim 2, wherein the first outer diameter is smaller than a diameter of the puncture.

5. The arteriotomy system of claim 1, wherein the tissue cutting element comprises a radiofrequency (RF) electrode.

6. The arteriotomy system of claim 1, wherein the tissue cutting element comprises a distal probe configured to perform electrocautery.

7. The arteriotomy system of claim 1, wherein the tissue cutting element comprises at least one extendable blade.

8. The arteriotomy system of claim 1, wherein the elongated cylindrical body comprises a beveled distal end.

9. The arteriotomy system of claim 1, wherein the conduit comprises a sheath or a second blood vessel.

10. The arteriotomy system of claim 1, wherein the puncture element comprises a removable guidewire extending therethrough.

11. The arteriotomy system of claim 10, wherein the capture element is configured to slidably advance along the guidewire.

12. A method of an arteriotomy system, the method comprising: A puncture is formed along the wall of a first blood vessel of the patient, the puncture being formed at a central position of a conduit passage of the conduit by a central puncture device of the arteriotomy formation system, the central puncture device comprising: an elongated cylindrical body including an outer wall slidably engaging a conduit inner wall of the conduit, the conduit being mated to a first blood vessel, the elongated cylindrical body including a central passage extending along a longitudinal axis of the elongated cylindrical body; and a puncture element movable along the central passage, the puncture element movable between a retracted configuration in which a distal end of the puncture element is located within the central passage and an extended configuration in which the distal end of the puncture element extends out of the elongated columnar body and the puncture element extends along the longitudinal axis of the elongated columnar body, thereby allowing the puncture to be formed along the wall of the first blood vessel at a central location of the conduit passage of the conduit; and An arteriotomy is formed along the wall of the first blood vessel, the arteriotomy being formed at a position centered relative to the conduit passage of the conduit by an arteriotomy forming device, the arteriotomy forming device comprising: a tissue fixation element comprising an elongated body having a fixation passage extending along a length of the tissue fixation element; a tissue capture element configured to form a first configuration having a first outer diameter and a second configuration having a second outer diameter, the second outer diameter being greater than the first outer diameter, the first configuration allowing the capture element to pass through the puncture and the second configuration allowing the tissue capture element to capture tissue excised from the wall of the first blood vessel; and A tissue cutting element movable relative to the tissue fixation element and the tissue capture element to form an arteriotomy along the wall of the first blood vessel, the tissue cutting element comprising an outer cutting wall that slidably engages an inner conduit wall of the conduit and forms an arteriotomy along the first blood vessel such that the arteriotomy is centered relative to the conduit passage.

13. The method according to claim 12, further comprising: capturing, by the tissue capturing element, tissue that has been cut from the wall of the first blood vessel; and The captured tissue is removed from the patient.

14. The method of claim 12, wherein the tissue capture element comprises an inflatable balloon.

15. The method of claim 14, wherein the inflatable balloon is formed into a disc shape in the second configuration.

16. The method of claim 14, wherein the first outer diameter is smaller than a diameter of the puncture.

17. The method of claim 12, wherein the tissue cutting element comprises a radio frequency (RF) electrode.

18. The method of claim 12, wherein the tissue cutting element comprises a distal probe configured to perform electrocautery.

19. The method of claim 12, wherein the tissue cutting element comprises at least one extendable blade.

20. The method of claim 12, wherein the elongated cylindrical body comprises a beveled distal end.

21. The method of claim 12, wherein the conduit comprises a sheath or a second blood vessel.

22. The method of claim 12, wherein the puncture element comprises a removable guidewire extending therethrough.

23. The method of claim 22, wherein the capture element is configured to slidably advance along the guidewire.

Images