The invention relates generally to a suturing device. More specifically, the invention relates to a device and method for suturing a fascial connective tissue layer that is proximal to an region under treatment.
Many types of surgical procedures are being adapted from manual/open procedures to a minimally invasive endovascular approach. Surgical aortic valve replacement (SAVR) has transitioned in many high-risk and prohibitive-risk patients to trans-catheter aortic valve replacement (TAVR). Abdominal and thoracic aortic aneurysms are being treated through a percutaneous endovascular aneurysm repair (PEVAR). In order to perform many of these procedures, a large-bore sheath is used to access the vascular system of a patient through the femoral artery. This sheath is placed over a dilator and inserted through the wall of a blood vessel in order to obtain this access, and may thereafter be used for guiding medical instruments such as catheters, guide wires and the endovascular devices into the circulatory system of a living being.
To perform these procedures, access into the body through layers of tissue is required to reach the femoral artery. In gaining access to different portions of the body, different layers of tissue must be separated or penetrated. These layers can include skin, subcutaneous fat, fascia (e.g., connective tissue), muscle, arteries, veins, intestine, and other organs. Often, after access through these layers is achieved and the procedure is completed, these tissues must be approximated and sealed. The function of reapproximation can vary to include hemostasis, prevent hernia, contain gastrointestinal contents, etc.
Known in the art is the “Fascia Suture Technique” that uses a suture to reapproximate the fascial layers in the roof of the femoral triangle, which may include the fascia lata, cribriform fascia, and femoral sheath with the purpose of achieving hemostasis after arteriotomy is made in the femoral artery. This technique is employed by dissecting the dermal and adipose layers of tissue along the femoral access sheath, which remains in place following the procedure. Dissection is performed both proximal and distal to the femoral sheath until the fascia layers are exposed and visually identified. A suture is passed through the fascial layers surrounding the access site, and knotted in such a way as to create a purse-string closure surrounding the femoral access sheath. As the tapered sheath is withdrawn, the knot is tightened to achieve hemostasis by closing the fascia thus containing femoral blood loss to the space bounded by the tissues that define the femoral triangle (e.g. inguinal ligament, sartorius muscle, adductor longus muscle, cribriform fascia, fascia lata, psoas major muscle, iliacus muscle, and pectineus muscle) and by resisting systolic blood pressure within the enclosed space. The wire is left in place until hemostasis is confirmed, the wire is then removed and the knot is subsequently tightened and locked. What is needed is a fascia suture technique for enabling a percutaneous, device-based solution that precludes the requirement for manual dissection and visualization of the fascial layers during closure.
To address the needs in the art, a suturing device is provided that includes a suture positioning assembly that is slidably attachable to an exterior of a sheath, where a housing of the suture positioning assembly includes a housing nose, a primary suture having primary suture connectors, an end effector, and an end effector actuator, where a distal end of the housing nose includes an intravascular tip, a slide limiter, and a fascia receiving surface, where the intravascular tip includes a blood contact indicator to receive blood flow from an artery, where the intravascular tip is configured for insertion into the artery when disposed beneath a fascial layer, where the fascia receiving surface is configured for accepting a perimeter edge of a dilated hole of the fascial layer, where the housing nose further includes an intermediary suture having intermediary suture connectors, where the primary suture connecters are configured for connection to the intermediary suture connectors, where the end effector actuator is disposed to operate the end effector to hold the facial layer hole in a position for suturing by the intermediary suture connected to the primary suture.
In one aspect of the invention, the end effector can include a straight needle, or a curved needle.
In another aspect of the invention, the housing nose further includes a tissue capturing device that is configured to deploy from the housing nose into, beneath, or above the fascial layer and draw the dilated hole in the fascial layer to the fascia receiving surface.
In a further aspect of the invention, the housing nose further includes a dilation controller, where the dilation controller is configured to change in size to alter a diameter of the dilated hole in the facial layer, where the dilation controller is configured to create resistance to the suture positioning assembly in being retracted from the facial layer along the lumen access sheath, where the created resistance is sufficient to indicate that the housing nose is securely held in place by circumferential tension of the dilated hole of the fascial layer on the fascia receiving surface. Here, the dilation control element can include an inflatable membrane, an expandable umbrella, or a shape changing collar.
In yet another aspect of the invention, the slide limiter is configured to induce an insertion resistance along the access sheath when the housing nose is desirably positioned on the facial layer, where the desirably positioned slide limiter establishes an upper bound against which the fascia will be stabilized and prevented from creeping further up the housing nose, where the desirably positioned slide limiter prevents the housing nose from passing through the fascia beyond the fascia receiving surface.
According to one aspect of the invention, the assembly slide limiter is a material that includes an elastomer, a complaint polymer, a complaint metallic element comprising nitinol, or an assembly of rigid elements designed to change shape upon contact with fascial layer.
In another aspect of the invention, the blood contact indicator includes a capillary, where the capillary spans from the housing nose to a proximal end of the housing, where a distal end of the capillary at the housing nose is configured to enter the body lumen, where blood flow through the capillary, or blood pressure in the capillary, or a presence of blood in the capillary is an indicator of the sheath being desirably position in an artery.
In a further aspect of the invention, the slidable attachment of the suture positioning assembly on the sheath includes clamping, hinged clamping, snap-fitting, stitching, or coaxial mating.
In on embodiment, the invention includes a suturing device that is slidably attachable to a sheath device, where the slidable attachment of the suturing device is configured to position a suture in an approximated state on a defect in a body lumen for suturing. Here, the body lumen can include an artery, a vein, or a bowel.
The current invention provides a surgical procedure and closure device that approximates and closes a defect in a tissue layer, such as a tissue layer superior to a blood vessel. In one example, the tissue defect may arise from the external introduction of an instrument for vascular or otherwise internal access to the body, e.g. percutaneous or surgical intervention. The tissue layer may be the femoral sheath, fascia lata and/or cribriform fascia that covers the roof of the femoral triangle, or other connective tissue layer e.g. abdominal fascia. The closure of such a tissue may allow for hemostasis to occur in the enclosed femoral triangle in order to create a natural method of tamponade around the femoral artery after removal of the procedural sheath. The ability to exert a greater compressive force around the arteriotomy from closure of the fascia above and the surrounding borders of the femoral triangle may allow the arteriotomy to naturally resolve. The anatomy of the femoral triangle includes the floor made up of the following muscles from lateral to medial: iliacus, psoas major, pectineus, and adductor longus; the superior border is made up of the inguinal ligament; the medial border is the adductor longus muscle; and the lateral border is comprised of the sartorius muscle. The current invention eliminates procedural steps that include opening the skin, manually dissecting down to the fascia, and directly suturing the fascia to close these internal tissues.
Turning now to the drawings,
In one aspect of the invention, the assembly slide limiter includes a material that includes a compliant elastomer that, upon contact with the proximal surface of the fascia, will deform and/or buckle, adding additional cross-sectional area to the upper bounding surface of the slide limiter, creating a broader upper bound of the slide limiter with which to prevent the fascia from creeping up further up the housing nose beyond the fascia receiving surface. Here, the slide limiter can be the elastomer, complaint polymer, complaint metallic element comprising nitinol, or an assembly of rigid elements designed to change shape upon contact with fascial layer.
The current invention enables one to approximate tissues during or following interventional medical procedures, such as open surgery, laparoscopic surgery, endoscopy, endovascular surgery and procedures, and cardiac catheterizations is portrayed. The invention may be used in a percutaneous or open surgical fashion and approximate a variety of tissues, such as skin, subcutaneous fat, fascia, muscle, or vascular tissue. Further, the tissue approximation device may be used with the intent of sealing tissue to achieve vascular hemostasis, prevent hernias, obtain watertight or airtight closure of tissue layers, or approximate and close disjointed tissues, for example. Tissue sealing of any of the previously described tissues may be achieved by a variety of mechanical techniques such as suture-like materials, clips, hook-and-loop fasteners, patches, plugs, clamps, and/or biological and synthetic adhesives. The invention may be placed directly on the tissue of interest or be integrated with an instrument of preference, such as a cardiovascular sheath, a guidewire for maintaining access to a vessel or procedural space, or a laparoscopic surgery port, trocar, or other surgical or procedural access instrument.
End effector 400, which may be a barbed needle tip, is permanently affixed to its axial shaft 310 housed within device body lumen 304. The axial shaft 310 of the end effector 400, as described previously, is stored such that it passes through a pre-tied surgical knot 311 comprised of the junction between a suture end 314 that is stored internal to the device within device lumen 304 and an opposing suture end 312 that may be stored external to the device or within lumen 304.
When tissue has been folded or tented into the receiving surface, for example a concave feature or planar shelf, of device nose 104 via deployment and retraction of end effectors 400, the user may actuate end effectors 400 by applying compressive force to their axial shafts 301 and 310 via handles or actuators 315 to pass the end effectors through the fold in the tissue of interest, as shown in
Shown in
To achieve a coaxial mate with the suture positioning assembly 100 as shown in
In a further aspect of the invention, the slidable attachment of the suture positioning assembly on the sheath to achieve coaxial mating of the suture positioning assembly with the sheath includes clamping, hinged clamping, clamping via hinged cams, springed hinges, snap-fitting, stitching, tongue-and-groove mating, dove-tail mating, ratchet mating, threaded connnectors or coaxial mating. The suture positioning assembly may be a single deformable component so as to achieve the coaxial mate with the sheath, or it may be comprised of discrete halves to be radially/circumferentially oriented around the sheath so as to mate with each other and create a coaxial mate, or a mate with which the central axes of the suture positioning assembly and of the sheath are offset but remain parallel.
Shown in
The material of the device, particularly in, but not limited to the location of the nose 104 may be sufficiently flexible so as to allow the elastic deformation of the nose or device body and subsequent coaxial mating of the suture positioning assembly 100 with the access sheath 101. The mating surfaces of the suture positioning assembly 100 with sheath 101 may incorporate gaskets, bushings, springs, hydrophilic coatings or other mechanism(s) to ensure a tight, coaxial sliding junction with the access instrument. The independence of the suture positioning assembly 100 from the sheath 101 enables the device to perform the intended tissue manipulation either at the start of a procedure or at the end of a procedure, without the mandate that the access sheath be removed and “threaded” through the device in order to obtain a coaxial orientation of the two components.
According to further embodiments of the invention, the housing nose 104 can also include a dilation controller, where the dilation controller is configured to change in size to alter a diameter of said dilated hole in facial layer 202, where the dilation controller is configured to create resistance when the suture positioning assembly 100 is retracted from the facial layer 201 along said lumen access sheath 101, where the created resistance is sufficient to indicate that the housing nose 104 is securely held in place by circumferential tension of the dilated hole 204 of said fascial layer on said fascia receiving surface.
In one embodiment, the end effectors may be a coiled wire with sufficient stiffness to puncture and secure into a biological tissue of interest for subsequent pushing, pulling, and analogous tissue manipulation. The end effectors may embody or utilize similar tissue securement mechanisms such as opposing graspers, hooks, barbs, suction, or adhesives. After approximation of the suture positioning assembly 100 to the tissue of interest 202, the end effectors 400 may be secured to the tissue of interest by rotating and applying axial compression to their axial shafts via handles/actuators at the end of the end-effector axial shaft proximal to the user, in the direction of the tissue of interest, which effectively captures the tissue of interest e.g. fascia. The travel of the end effectors is limited by a mechanical hard stop, or “shoulder” feature 113 (see
The present invention has now been described in accordance with several exemplary embodiments, which are intended to be illustrative in all aspects, rather than restrictive. Thus, the present invention is capable of many variations in detailed implementation, which may be derived from the description contained herein by a person of ordinary skill in the art. For example the needles themselves could be curved or straight, flexible or rigid, etc while still performing the mating of “barb” with “cuff” by traversing the tissue layer once, twice, or up to four times per needle.
All such variations are considered to be within the scope and spirit of the present invention as defined by the following claims and their legal equivalents.
Filing Document | Filing Date | Country | Kind |
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PCT/US2018/028296 | 4/19/2018 | WO | 00 |
Number | Date | Country | |
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62486978 | Apr 2017 | US |