Patent Application
20250221711
The terms “invention,” “the invention,” “this invention”, the “present technology” and “the present invention” used in this patent are intended to refer broadly to all of the subject matter of this patent and the patent claims below. Statements containing these terms should be understood not to limit the subject matter described herein or to limit the meaning or scope of the patent claims below. Embodiments of the invention covered by this patent are defined by the claims below, not this summary. This summary is a high-level overview of various embodiments of the invention and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this patent, any or all drawings, and each claim.
The present technology includes devices for forming an anastomosis between two lumens, for example a first lumen and a second lumen. In embodiments, the device may include a staple receiving assembly and a staple dispensing assembly. The staple receiving assembly may include a first body defining a bottom surface surrounding a first central opening and a plurality of staple receiving cavities positioned around the first central opening. The staple dispensing assembly may include a second body defining a top surface surrounding a second central opening and a plurality of staple dispensing cavities positioned around the second central opening. The device may also include a plurality of linear staples positioned within the plurality of staple dispensing cavities. The staple receiving assembly and the staple dispensing assembly may be designed to retain everted ends of the first and second lumens between the bottom surface and the top surface. Further, the staple dispensing assembly may be designed to propel the plurality of linear staples from the plurality of staple dispensing cavities through the retained everted ends of the first and second lumens toward the plurality of staple receiving cavities in order to form an anastomosis between the first lumen and the second lumen.
In some embodiments, the first body may define a first gap connected to the first central opening to define a first open loop and the second body may define a second gap connected to the second central opening to define a second open loop. The first and second gaps may be designed so that after the anastomosis is formed the first lumen is removable from the first central opening through the first gap and the second lumen is removable from the second central opening through the second gap. In some embodiments, the first central opening and the second central opening are circular. In some embodiments, the first body defines a first internal vacuum passage fluidically coupled to a plurality of first suction openings on the bottom surface designed to be coupled to a vacuum source in order to retain the everted end of the first lumen to the bottom surface, and the second body defines a second internal vacuum passage fluidically coupled to a plurality of second suction openings on the top surface designed to be coupled to the vacuum source in order to retain the everted end of the second lumen to the top surface. The plurality of first suction openings may be radially positioned around the first central opening on the bottom surface, and the plurality of second suction openings may be radially positioned around the second central opening on the top surface.
In embodiments, the linear staples may each include a piercing end and a tail end on opposite sides of a longitudinal axis of the linear staple. The linear staples may each further include a first set of barbs between the piercing end and the tail end, and a second set of barbs between the first set of bards and the tail end. Each linear staple may be designed to retain the everted end of the first lumen between the first set of barbs and the second set of barbs, and be designed to retain the everted end of the second lumen between the second set of barbs and the tail end.
In embodiments, the second body may define an internal pressurized air passage fluidically coupled to the plurality of staple dispensing cavities and designed to be coupled to a pressurized air source in order to pneumatically propel the staples out of the plurality of staple dispensing cavities toward the plurality of staple receiving cavities.
In embodiments, devices may also include a hinge coupled to the staple receiving assembly and the staple dispensing assembly. The hinge may be designed to allow the device to transition between an open configuration wherein the staple receiving assembly and the staple dispensing assembly are spaced apart, and a closed configuration wherein the staple receiving assembly and the staple dispensing assembly retain the everted ends of the first and second lumens between the bottom surface and the top surface and the plurality of staple dispensing cavities are aligned with the plurality of staple receiving cavities.
In embodiments, the staple receiving assembly includes a plurality of first magnets arranged around the first central opening. And the staple dispensing assembly includes a plurality of second magnets arranged around the first central opening. The first and second magnets may be arranged in order to be attracted and cause the plurality of staple dispensing cavities to be aligned with the plurality of staple receiving cavities.
In embodiments, the devices may be used in a method for forming an anastomosis between a first lumen and a second lumen. The devices may include a staple receiving assembly including a first body defining a bottom surface surrounding a first central opening and a plurality of staple receiving cavities positioned around the first central opening, a staple dispensing assembly including a second body defining a top surface surrounding a second central opening and a plurality of staple dispensing cavities positioned around the second central opening, and a plurality of linear staples positioned within the plurality of staple dispensing cavities. The method may include a step of positioning a first end of the first lumen within the first central opening and everting the first end onto the bottom surface. The method may also include a step of positioning a second end of the second lumen within the second central opening and everting the second end onto the top surface. The method may also include a step of retaining the first end and the second end between the top surface and the bottom surface. The method may also include a step of propelling the plurality of linear staples from the plurality of staple dispensing cavities through the retained everted ends of the first and second lumens toward the plurality of staple receiving cavities in order to form an anastomosis between the first lumen and the second lumen.
In embodiments, the first body may define a first gap connected to the first central opening to define a first open loop, and the second body may define a second gap connected to the second central opening to define a second open loop. The method may include the step of removing the first lumen from the first central opening through the first gap and removing the second lumen from the second central opening through the second gap after the anastomosis is formed. The first central opening and the second central opening may be circular. The first body may define a first internal vacuum passage fluidically coupled to a plurality of first suction openings on the bottom surface, and the second body may define a second internal vacuum passage fluidically coupled to a plurality of second suction openings on the top surface. Methods may include the step of coupling a vacuum source to the first plurality of suction openings in order to evert the first end of the first lumen to the bottom surface. Methods may also include the step of coupling the vacuum source to the second plurality of suction openings in order to evert the second end of the second lumen to the top surface.
In embodiments, the plurality of first suction openings may be radially positioned around the first central opening on the bottom surface, and the plurality of second suction openings may be radially positioned around the second central opening on the top surface.
In embodiments, the methods may include the linear staples each including a piercing end and a tail end on opposite sides of a longitudinal axis of the linear staple. The linear staples may each further include a first set of barbs between the piercing end and the tail end, and a second set of barbs between the first set of bards and the tail end. In some embodiments, the method step of propelling the plurality of linear staples includes piercing the first end and the second end with the piercing end. In some embodiments, the anastomosis between the first lumen and the second lumen is formed by each linear staple retaining the everted first end of the first lumen between the first set of barbs and the second set of barbs, and retaining the everted second end of the second lumen between the second set of barbs and the tail end.
In embodiments, the second body defines an internal pressurized air passage fluidically coupled to the plurality of staple dispensing cavities, and the method further includes coupling the internal pressurized air passage to a pressurized air source in order to pneumatically propel the staples out of the plurality of staple dispensing cavities toward the plurality of staple receiving cavities.
In embodiments, the device further includes a hinge coupled to the staple receiving assembly and the staple dispensing assembly, and the method includes transitioning the device with the hinge from an open configuration wherein the staple receiving assembly and the staple dispensing assembly are spaced apart, to a closed configuration wherein the staple receiving assembly and the staple dispensing assembly retain the everted first end and second end of the first and second lumens between the bottom surface and the top surface and the plurality of staple dispensing cavities are aligned with the plurality of staple receiving cavities.
In embodiments, the first lumen and the second lumen are blood vessels.
Various implementations described in the present disclosure can include additional systems, methods, features, and advantages, which cannot necessarily be expressly disclosed herein but will be apparent to one of ordinary skill in the art upon examination of the following detailed description and accompanying drawings. It is intended that all such systems, methods, features, and advantages be included within the present disclosure and protected by the accompanying claims.
The features and components of the following figures are illustrated to emphasize the general principles of the present disclosure. Corresponding features and components throughout the figures can be designated by matching reference characters for the sake of consistency and clarity.
The subject matter of embodiments of the present invention is described here with specificity to meet statutory requirements, but this description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be interpreted as implying any particular order or arrangement among or between various steps or elements except when the order of individual steps or arrangement of elements is explicitly described. Directional references such as “up,” “down,” “top,” “left,” “right,” “front,” and “back,” among others are intended to refer to the orientation as illustrated and described in the figure (or figures) to which the components and directions are referencing.
The present technology relates to devices 300 for forming anastomoses between two portions of material, for example forming anastomoses between two lumens.
The applicator end 302 may include a staple dispensing assembly 306 and a staple receiving assembly 308. The staple dispensing assembly 306 and staple receiving assembly 308 may be attached together with a hinge 309 so that the staple dispensing assembly 306 and staple receiving assembly 308 may pivot relative to each other between an open configuration wherein the staple dispensing assembly 306 and the staple receiving assembly 308 are spaced apart from each other, as shown, for example, in
In some embodiments, the staple dispensing assembly 306 and staple receiving assembly 308 may be detachable from the handle end 304 so that a set of the staple dispensing assembly 306 and the staple receiving assembly 308 previously used to form an anastomosis may be removed from the device 300, e.g. for disposal and/or sanitization (e.g. autoclaved), and replaced with a new set of a staple dispensing assembly 306 and a staple receiving assembly 308. This allows the handle end 304 to be reused during the forming of multiple anastomoses. The staple dispensing assembly 306 and staple receiving assembly 308 may be separately detachable or may be detachable as an assembly of both the staple dispensing assembly 306 and the staple receiving assembly 308 from the hinge 309 and/or the handle end 304.
In some embodiments, the staples 310 dispensed from the staple dispensing assembly 306 may be linear staples, in that the staples 310 extend along a substantially linear longitudinal axis that does not include substantial curvature or bends. In some embodiments, unlike conventional surgical staples which are deformed during application in order to create a mechanical locking shape or clamping force, for example by bending the staples from a first non-linear shape to a second non-linear shape, the linear staples 310 as disclosed herein may maintain substantially the same non-deformed shape prior to, during and after application.
In some embodiments, the tail end 405 may extend radially from the longitudinal axis 402. The tail end 405 may extend the same distance or greater radially from longitudinal axis 402 relative to the first and second set of barbs 406 and 408. The tail end 405 may be circular in shape. The tail end 405 may be spaced apart from the undercut portion 416 of the second set of barbs 408. The staple 310 may define a first undercut recess 424 between the undercut portion 416 of the first set of barbs 406 and the angle edge 412 of the second set of barbs 408 for retaining the first portion of material 418, as shown in
The staple 310 may also define a second undercut recess 422 between the undercut portion 416 of the second set of barbs 408 and the tail end 405 for retaining the second portion of material 420, as shown in
As shown in
The first body 502 of the staple receiving assembly 308 defines a bottom surface 514. The bottom surface 514 may be planar and extends around a perimeter of the central opening 504. The first body 502 defines a plurality of staple receiving cavities 516, into which the piercing ends 404 of staples 310 are received when coupling a first portion of material to a second portion of material. The portion of bottom surface 514 surrounding each staple receiving cavity 516 provides backing support for the outside surface of the first portion of material during application of the staple 310.
The first body 502 of the staple receiving assembly 308 further defines an internal vacuum passage fluidically coupled to a plurality of suction openings 518 defined on the bottom surface of the first body 502, and a vacuum port 520. The plurality of suction openings 518 may be positioned between the staple receiving cavities 516. During use, the vacuum port 520 is coupled to a vacuum source, for example the vacuum source available in an operating room, in order to cause the first portion of material to be retained against the bottom surface 514 of the first body 502 due to the difference in pressure between the vacuum and atmosphere. Vacuum retention is beneficial in retaining the first portion of material in that the material is not damaged, and may be easily repositioned by releasing the vacuum and reapplying the vacuum. In some embodiments, the device 300 includes a vacuum control selector, e.g. a knob on the handle end, for controlling the vacuum amount and therefore the pressure for retaining the first portion of material.
As shown in
The second body 602 of the staple dispensing assembly 306 defines a top surface 614. The top surface 614 may be planar and extends around a perimeter of the central opening 604. The second body 602 define a plurality of staple dispensing cavities 617, out of which the staples 310 are dispensed with the piercing ends 404 of the staples 310 pointing out of the staple dispensing cavities 617 when coupling a first portion of material to a second portion of material. The top surface 614 is sized and shaped to correspond to the bottom surface 514 of the first body 502 of the staple receiving assembly. 308 As will be discussed in greater detail below, the overlapped first portion of material and second portion of material are retained between the top surface 614 and the bottom surface 514.
The plurality of staple dispensing cavities 617 are spaced radially around top surface 614 and are positioned to correspond with complementary staple receiving cavities 516 of the first body 502 of the staple receiving assembly 308. The plurality of staple dispensing cavities 617, and corresponding staple receiving cavities 516, may be uniformly spaced in a circle around the central openings 504 and 604, including the spacing of the staple receiving cavities 516 and staple dispensing cavities 617 of opposing sides of the gaps 512 and 612. In some embodiments, the hinge 309 maintains alignment of the staple dispensing assembly 306 and the staple receiving assembly 308 so that in the closed configuration, the staple dispensing cavities 617 overlap with the staple receiving cavities 516. In some embodiments, the staple dispensing assembly 306 and the staple receiving assembly 308 each include magnets 521 complementarily positioned so that in the closed configuration the attraction of the complementary magnets causes the staple dispensing cavities 617 to align with the staple receiving cavities 516.
The second body 602 of the staple dispensing assembly 306 further defines an internal vacuum passage fluidically coupled to a plurality of suction openings 618 defined on the top surface 614 of the second body 602, and a vacuum port 620. The plurality of suction openings 618 may be positioned between the staple dispensing cavities 617. During use, the vacuum port 620 is coupled to a vacuum source, for example the vacuum source available in an operating room, in order to cause the second portion of material to be retained against the top surface 614 of the second body 602 due to the difference in pressure between the vacuum and atmosphere. Vacuum retention is beneficial in retaining the second portion of material in that the material is not damaged, and may be easily repositioned by releasing the vacuum and reapplying the vacuum. As noted above, in some embodiments, the device 300 may include a vacuum control selector. The vacuum control selector may allow for individual and/or combined control of the vacuum amount of the first plurality of suction openings 518 and the second plurality of suction openings 618.
In some embodiments, for example as shown in
During use, the pressurized air port 622 may be coupled to a pressurized air source, for example the pressurized air source available in an operating room. As shown in
In some embodiments, a device 300 may include two staple dispensing/receiving assemblies including the features of both the staple dispensing assemblies 306 and staple receiving assemblies 308, as disclosed above. In such embodiments, staples 310 may be delivered in opposite directions to form an anastomosis.
With the ends 703 and 704 of the lumens 701 and 702 retained against the top surface 614 and bottom surface 514 in the everted configuration and with the device 300 in the open configuration, the device 300 may be transitioned to the closed configuration, as shown in
With the first lumen 701 and second lumen 702 aligned and each end 703 and 704 everted, the staple dispensing assembly 306 may be actuated in order to propel the staples 310 through the end 703 of the first lumen 701. As noted above, the staples 310 may be pneumatically propelled into the material, and the bottom surface 514 of the staple receiving assembly 308 may act as a backing to support the overlapped material so that the staples may pierce through both portions of material with the piercing ends 404 occupying a portion of the staple receiving cavities 516, and the tail ends 405 abutting the outer surface of the lower portion of material. In some embodiments, the staples 310 may be simultaneously propelled into the second and first portions of material. The number and or size of the staples delivered by a staple dispensing assembly may be based on the size of the lumen. For example as shown in
With the staples 310 positioned within the ends 703 and 704 of the first and second lumens 701 and 702 the device 300 may be transitioned from the closed configuration to the open configuration. In some embodiments, prior to transitioning, retaining the first and second portions of material with the suction may be ceased. In the open configuration, the first and second lumens 701 and 702 may be compressed radially so that the coupled lumens may be removed through the gaps 512 and 612 of the staple receiving assembly 308 and staple dispensing assembly 306, as shown in
With the anastomosis formed, as shown in
Other variations are within the spirit of the present disclosure. Thus, while the disclosed techniques are susceptible to various modifications and alternative constructions, certain illustrated examples thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the disclosure to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions and equivalents falling within the spirit and scope of the disclosure, as defined in the appended claims. For instance, any of the examples, alternative examples, etc., and the concepts thereof may be applied to any other examples described and/or within the spirit and scope of the disclosure.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the disclosed examples (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. The phrase “based on” should be understood to be open-ended, and not limiting in any way, and is intended to be interpreted or otherwise read as “based at least in part on,” where appropriate. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate examples of the disclosure and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosure.
This application claims priority to U.S. Provisional Application No. 63/273,647, filed Oct. 29, 2021, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. An anastomosis is a connection between two things, for example two lumens. A vascular anastomosis (VA) is a procedure whereby two ends of a severed blood vessel, such as an artery or vein, are joined in order to establish blood flow into or out of an organ or limb. Vascular anastomosis may be currently performed by hand sewing the two ends of the blood vessel together using needle and sutures, for example as shown in FIGS. 1A and 1B. A hand-sewn anastomosis can take roughly 45-60 minutes even for an experienced surgeon to complete, and can take longer for inexperienced surgeons or difficult-to-reach anatomic locations. The duration of hand sewing therefore has a long time that the tissue is denied blood (i.e. TTA), which is detrimental to the tissue health. Existing devices for forming a vascular anastomosis include a device for example as shown in FIGS. 2A-2C, marketed as the Synovis® MCA microvascular coupling device. The device as shown in FIGS. 2A and 2B includes two rings with spikes, wherein ends of blood vessels are everted over the spikes of the rings. The rings are brought together and receive the spikes of the opposing ring, thereby coupling the ends of the blood vessels therebetween, wherein the rigid rings remain a part of the anastomosis after the procedure is performed. The device of FIGS. 2A-2C is disadvantageous in that the procedure has a TTA of 20-100 minutes, requires a high level of surgical dexterity to evert the blood vessels over the spikes, cannot be adapted for vessels over 5 mm diameter, and due to the rigid rings does not allow for expansion of the blood vessel with every heartbeat. Accordingly, there is a need for a device for forming an anastomosis, for example a vascular anastomosis, with a low TTA, not requiring a high level of surgical dexterity, adaptable to vessels over 5 mm in diameter and/or allowing for expansion of the blood vessel with every heartbeat.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/048066 | 10/27/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63273647 | Oct 2021 | US |
