The present embodiments relate generally to medical devices, and more particularly, to apparatus and methods for coupling a graft member to tissue, closing a bodily opening, and the like.
Perforations in tissue or bodily walls may be formed intentionally or unintentionally. For example, an unintentional ventral abdominal hernia may be formed in the abdominal wall due to heavy lifting, coughing, strain imposed during a bowel movement or urination, fluid in the abdominal cavity, or other reasons.
Intentional perforations may be formed, for example, during surgical procedures such as translumenal procedures. In a translumenal procedure, one or more instruments, such as an endoscope, may be inserted through a visceral wall, such as the stomach wall. During a translumenal procedure, a closure instrument may be used to close the perforation in the visceral wall. Depending on the structure comprising the perforation, it may be difficult to adequately close the perforation and prevent leakage of bodily fluids.
Attempts to seal perforations have been attempted by coupling a graft member to tissue. For example, during hernia repair, a graft material such as a mesh or patch may be disposed to cover the perforation. The graft material may completely overlap with the perforation, and the edges of the graft material may at least partially overlap with tissue surrounding the perforation. The graft material then may be secured to the surrounding tissue in an attempt to effectively cover and seal the perforation.
In order to secure the graft material to the surrounding tissue, sutures commonly are manually threaded through the full thickness of the surrounding tissue. In the case of a ventral abdominal hernia, the sutures may be threaded through the thickness of the abdominal wall, then tied down and knotted. However, such manual suturing techniques may be time consuming and/or difficult to perform.
In addition to covering and sealing perforations, there are various other instances in which it may be desirable to couple a graft material to tissue. For example, it may become necessary or desirable to couple the graft material to a region of tissue for purposes of reconstructing the local tissue. Whether a graft material is coupled to tissue to reconstruct local tissue, seal a perforation, or another purpose, it would be desirable to provide apparatus and methods for quickly and effectively coupling the graft material to the tissue.
The present embodiments provide a tacking device for engaging tissue, which may be useful for coupling a graft to tissue or facilitating closure of a bodily opening. In one embodiment, a tacking device is provided comprising a first wire having proximal and distal ends, a proximal deployable member formed at the proximal end of the first wire, and a distal deployable member formed at the distal end of the first wire. Similarly, a second wire has proximal and distal ends, a proximal deployable member formed at the proximal end of the second wire, and a distal deployable member formed at the distal end of the second wire. Further, a third wire has proximal and distal ends, a proximal deployable member formed at the proximal end of the third wire, and a distal deployable member formed at the distal end of the third wire. Each of the proximal deployable members of the first, second and third wires has contracted and expanded states, and further, each of the distal deployable members of the first, second and third wires has contracted and expanded states. Central regions of each of the first, second and third wires are affixed to one another.
In one embodiment, each of the proximal and distal deployable members of the first, second and third wires comprise hook-shaped configurations in the expanded states. The proximal and distal deployable members each may comprise a nickel-titanium alloy that is configured to self-expand to the hook-shaped configuration.
In one embodiment, an end region of the distal deployable member of the first wire is substantially parallel to a longitudinal axis of the first wire in the contracted state, and further, the distal deployable member of the first wire retroflexes in the expanded state to be radially spaced apart from, and substantially parallel to, the longitudinal axis of the first wire. Similarly, an end region of the proximal deployable member of the first wire may be substantially parallel to a longitudinal axis of the first wire in the contracted state, and retroflexes in the expanded state to be radially spaced apart from, and substantially parallel to, the longitudinal axis of the first wire.
The tacking device may be delivered to a target site using an insertion tool comprising a hollow lumen having an inner diameter configured to receive the tacking device having the proximal and distal deployable members. The proximal and distal deployable members are configured to be held in the contracted states when disposed within the hollow lumen. In the contracted states, the proximal and distal deployable members may be oriented in substantially longitudinally directions with respect to the insertion tool.
In an exemplary use of the tacking device for coupling graft member to tissue, the graft member may be positioned over a selected region of the tissue. The insertion tool may be advanced to penetrate through the graft member and through a portion of the tissue. The insertion tool then may be proximally retracted with respect to the tacking device to cause the distal deployable members to expand and engage the tissue. Further retraction of the insertion tool with respect to the tacking device may cause the proximal deployable members to expand and engage the graft member. A stylet loaded into the hollow lumen may abut the proximal deployable members to facilitate retraction of the insertion tool with respect to the tacking device. If desired, multiple tacking devices may be sequentially loaded within the hollow lumen of the insertion tool and then sequentially deployed to secure the tissue to the graft material at multiple different locations.
Optionally, at least one loop member configured to receive a suture may be used for further securing the graft member to the tissue. The loop member may be integrally formed with a wire of the tacking device by bending a portion of the wire in an arch-shaped manner. In use, multiple tacking devices comprising loop members may be deployed, and a suture may be threaded through the loop members and actuated in a purse-string fashion.
Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
The invention can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
In the present application, the term “proximal” refers to a direction that is generally towards a physician during a medical procedure, while the term “distal” refers to a direction that is generally towards a target site within a patient's anatomy during a medical procedure.
Referring now to
The proximal deployable members 35-37 and the distal deployable members 45-47 each may be affixed relative to the tube member 22. In one embodiment, each of the proximal and distal deployable members 35-37 and 45-47 may be separate and discrete elements. Accordingly, six separate deployable members may be provided. Specifically, the three proximal deployable members 35-37 may be coupled to the tube member 22 near the proximal end 24 of the tube member 22. The three proximal deployable members 35-37 may be coupled to the proximal end 24 of the tube member 22 using an adhesive, frictional fit, mechanical device or other suitable mechanism or processes. Similarly, the three distal deployable members 45-47 may be coupled to the distal end 26 of the tube member 22 using an adhesive, frictional fit, mechanical device or other suitable mechanism.
In an alternative embodiment, instead of providing six discrete deployable members, three wires may be disposed through the entirety of tube member 22. In this embodiment, a first wire may comprise a proximal end that forms the deployable member 35 and a distal end that forms the deployable member 45, while a central region of the same wire is disposed through the entirety of the tube member 22. Similarly, second and third wires may be disposed through the entirety of the tube member 22 to form the remaining proximal and distal deployable members. In this embodiment, the three wires that extend through the length of the tube member 22 may be affixed to an interior surface of the tube member 22, for example, using an adhesive or mechanical device. The three wires also may be sized to create a frictional fit against each other and/or an interior surface of the tube member 22, thereby inhibiting movement of the proximal and distal deployable members 35-37 and 45-47 in longitudinal directions with respect to the tube member 22.
While six total deployable members 35-37 and 45-47 are depicted, including three at both the proximal and distal ends of the tacking device 20, it will be apparent that greater or fewer deployable members may be employed. Moreover, the deployable members 35-37 and 45-47 may comprise any shape suitable for engaging, penetrating and/or abutting tissue, for purposes explained further below, and need not necessarily assume the expanded shape depicted in
The tube member 22 may comprise any suitable shape and material. Solely by way of example, the tube member 22 may comprise stainless steel or a biocompatible plastic. The tube member 22 may be cylindrically-shaped, as depicted in
Alternatively, as explained further below with respect to
Referring still to
A separation point SP generally defines a point where the proximal deployable members 35-37 begin to radially space apart from one another, while a separation point SD generally defines a point where the distal deployable members 45-47 begin to radially space apart from one another, as shown in
Further, a longitudinal distance L1 between the ends 39 and 49 of the tacking device 20 may be varied to engage tissue in a desirable manner. For example, the longitudinal distance L1 may be dimensioned to be substantially equal to or less than the combined thickness t1 and t2 of a tissue 74 and a graft member 80, respectively, as shown in
The dimension of the tacking device 20 may be tailored based on a particular surgical procedure, a particular patient's anatomy and/or other factors. However, for illustrative purposes, in a ventral hernia repair operation, the longitudinal length of the tube member 22 may range from about 2 mm to about 10 mm, the straightened (delivery or non-curved) length of the proximal deployable members 35-37 may range from about 5 mm to about 50 mm, the straightened (delivery or non-curved) length of the distal deployable members 45-47 may range from about 5 mm to about 50 mm, the longitudinal distance L1 between the ends 39 and 49 may range from about 5 mm to about 30 mm, the outer diameter of the tube member 22 may range from about 0.3 mm to about 1.5 mm, and the outer diameter of the deployable member 35-37 and 45-47 may range from about 0.1 mm to about 0.5 mm. Such dimensions are provided for reference purposes only and are not intended to be limiting.
The deployable members 35-37 and 45-47 may comprise a shape-memory material, such as a nickel-titanium alloy (nitinol). If a shape-memory material such as nitinol is employed, the deployable members 35-37 and 45-47 may be manufactured such that they can assume the preconfigured expanded state shown in
In an example of the shape-memory effect, a nickel-titanium alloy having an initial configuration in the austenitic phase may be cooled below a transformation temperature (Mf) to the martensitic phase and then deformed to a second configuration. Upon heating to another transformation temperature (Af), the material may spontaneously return to its initial, predetermined configuration, as shown in
Alternatively, the deployable members 35-37 and 45-47 may be made from other metals and alloys that are biased, such that they may be restrained by the insertion tool 50 prior to deployment, but are inclined to return to their relaxed, expanded configuration upon deployment. Solely by way of example, the deployable members 35-37 and 45-47 may comprise other materials such as stainless steel, cobalt-chrome alloys, amorphous metals, tantalum, platinum, gold and titanium. The deployable members 35-37 and 45-47 also may be made from non-metallic materials, such as thermoplastics and other polymers. As noted above, the deployable members 35-37 and 45-47 may comprise any shape suitable for engaging, penetrating and/or abutting tissue, for purposes explained further below, and need not necessarily assume the curved shape depicted in
Referring to
In one embodiment, the insertion tool 50 comprises a needle-like body having a sharpened distal tip 52 and a hollow lumen 54, as shown in
The hollow lumen 54 of the insertion tool 50 may comprise an inner diameter than is larger than an outer diameter of the tacking device 20. Therefore, one or more tacking devices, such as six tacking devices 20a-20f, may be loaded into the hollow lumen 54 in a delivery configuration, as shown in
The multiple tacking devices 20a-20f may be inserted into the hollow lumen 54 of the insertion tool 50 in a sequential manner, whereby the proximal deployment mechanism 32a of the first tacking device 20a may abut the distal deployment mechanism 42b of the second tacking device 20b, as depicted in
A stylet 60 may be disposed for longitudinal movement within the hollow lumen 52 of the insertion tool 50, as shown in
The insertion tool 50 may comprise one or more markers 56, as shown in
Referring now to
The initial stages of the ventral hernia repair may be performed using techniques that are known. Specifically, an open technique or laparoscopic technique may be employed. In an open technique, an incision may be made in the abdominal wall and fat and scar tissue may be removed from the area. A graft member 80 then may be applied so that it overlaps the perforation 75, preferably by several millimeters or centimeters in each direction, as depicted in
The graft member 80 may comprise any suitable material for covering the perforation 75 and substantially or entirely inhibiting the protrusion of abdominal matter. In one embodiment, the graft member 80 may comprise small intestinal submucosa (SIS), such as SURGISIS® BIODESIGN™ Soft Tissue Graft, available from Cook Biotech, Inc., West Lafayette, Ind., which provides smart tissue remodeling through its three-dimensional extracellular matrix (ECM) that is colonized by host tissue cells and blood vessels, and provides a scaffold for connective and epithelial tissue growth and differentiation along with the ECM components. Preferably, the graft member 80 would be a one to four layer lyophilized soft tissue graft made from any number of tissue engineered products. Reconstituted or naturally-derived collagenous materials can be used, and such materials that are at least bioresorbable will provide an advantage, with materials that are bioremodelable and promote cellular invasion and ingrowth providing particular advantage. Suitable bioremodelable materials can be provided by collagenous ECMs possessing biotropic properties, including in certain forms angiogenic collagenous extracellular matrix materials. For example, suitable collagenous materials include ECMs such as submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, including liver basement membrane. Suitable submucosa materials for these purposes include, for instance, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa. The graft member 80 may also comprise a composite of a biomaterial and a biodegradeable polymer. Additional details may be found in U.S. Pat. No. 6,206,931 to Cook et al., the disclosure of which is incorporated herein by reference in its entirety.
Referring now to
In this example, the insertion tool 50 is carrying six sequential tacking devices 20a-20f, which may be disposed within the hollow lumen 54 of the insertion tool 50 as shown and explained with respect to
In a next step, the stylet 60 of
As the insertion tool 50 further is retracted proximally with respect to the tacking device 20a, the proximal deployable members 35-37 may assume their predetermined expanded configuration when are no longer radially constrained, as shown in
After the first tacking device 20a has been deployed, the insertion tool 50 may be repositioned to deploy another tacking device around the perimeter of the perforation 75. Each subsequent tacking device 20b-20f may be deployed in the same manner as the tacking device 20a. In this manner, the tacking devices 20a-20f may secure the graft member 80 around the perimeter of the perforation 75, as shown in
Optionally, the sheath member 58 of
In the embodiment of
While
Referring now to
The first wire 125 may comprise a proximal end that forms deployable member 135 and a distal end that forms deployable member 145, such that a central region of the first wire 125 is disposed through both tube portions 122 and 123. Similarly, the second and third wires 126 and 127 may be disposed through the entirety of the tube portions 122 and 123. The second wire 126 may comprise a proximal end that forms deployable member 136 and a distal end that forms deployable member 146, while the third wire 127 may comprise a proximal end that forms deployable member 137 and a distal end that forms deployable member 147. The three wires 125-127 may be affixed to an interior surface of the tube portions 122 and 123, for example, using an adhesive, frictional fit or mechanical device. Alternatively, the tube portions 122 and 123 may be omitted, and central regions of the first, second and third wires 125-127 may be affixed to one another, for example, using a solder or weld.
In the embodiment shown, the second wire 126 comprises a loop member 150, which may be formed by bending a central region of the wire that is disposed between the tube portions 122 and 123, as shown in
In alternative embodiments, one single tube member may be employed, in lieu of the proximal and distal tube portions 122 and 123, and the single tube member may comprise a slot or cutout, such that the loop member 150 may extend radially through the slot or cutout. There also may be a single strip of material connecting the proximal and distal tube portions 122 and 123. Further, the loop member 150 need not be formed integrally from any of the wires 125-127, but rather may be formed as a loop disposed on an exterior surface of the proximal and distal tube portions 122 and 123, or on an exterior surface of a single tube member if only one tube is used. Still further, while the loop member 150 is shown in a substantially central location, it may be placed closer to the proximal or distal ends of the tacking device 120.
Referring now to
Preferably, multiple tacking devices 120 having loop members 150 are sequentially positioned around the perforation 75 in a semi-annular or annular shape, for example, as shown above in
Further, in lieu of the loop members 150 described herein, other mechanisms for engaging and/or retaining sutures may be integrally formed with the tacking device 120 or externally attached thereto. Solely by way of example, such suture retaining mechanisms are explained in pending U.S. patent application Ser. No. 11/946,565, filed Nov. 28, 2007, the entire disclosure of which is hereby incorporated by reference in its entirety.
Various types of sutures 160 may be used in conjunction with embodiment of
While the examples shown above have illustratively described a tacking device that may be useful for coupling a graft member to tissue to cover and seal a perforation, the tacking devices 20 and 120 also may be used in other procedures. As noted above, the tacking devices 20 and 120 may be used to treat bodily walls during translumenal procedures. Further, the tacking devices 20 and 120 may be used to secure a graft member to tissue for reconstructing local tissue, and the like.
In yet further applications within the scope of the present embodiments, the tacking devices 20 and 120 need not be used for coupling a graft member to tissue. For example, the tacking devices 20 and 120 may be used in an anastomosis procedure. In order to create an anastomosis, for example, multiple tacking devices 20 or 120 may be deployed in a circular manner to couple a proximal vessel, duct or organ to a distal vessel, duct or organ. In such cases, a suitable insertion device, such as an endoscope, may be advanced through a bodily lumen such as the alimentary canal to a position proximate the target location. One or more components, such as the insertion tool 50, may be advanced through a working lumen of the endoscope. The distal end of the insertion tool 50 may be viewed under fluoroscopy, or via optical elements of the endoscope, or by some other visualization technique. Under suitable visualization, multiple tacking devices then may be delivered at one time, for example, using the insertion tool 50. Then, a hole may be punched through the middle of the deployed tacking devices to create a flow path between the proximal and distal vessels/ducts/organs. It will be apparent that still further applications of the tacking devices 20 and 120 are possible. Moreover, the insertion tool 50 may be used with or without an endoscope or similar device.
Referring now to
Referring now to
Referring now to
While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
This invention claims the benefit of priority of U.S. Provisional Application Ser. No. 61/047,293, entitled “Tacking Device,” filed Apr. 23, 2008, the disclosure of which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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61047293 | Apr 2008 | US |
Number | Date | Country | |
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Parent | 12428226 | Apr 2009 | US |
Child | 13454618 | US |