Patent Application
20140277131
The present invention relates generally to medical devices used for securing and approximating wounds and tissue regions. More particularly, the present invention relates to apparatus and methods for anchoring and securing tissue regions towards one another for wound repair and/or securing portions of tissue for various treatments.
Suturing tissues and performing suturing techniques in confined spaces remains a difficult challenge. The ability to tie knots requires a two-handed technique and is fraught with challenges especially when using endoscopic and/or laparoscopic instruments for treating, e.g., oropharyngeal tissues, or regions of the body where space constraints or exposed knots are an issue.
In addition to the difficulty in performing such techniques, the treatment outcomes are often less than ideal. For instance, when closing the oropharyngeal tissue with suture such as for an uvulopalatopharyngoplasty (UPPP) procedure, the suture typically tends to pull through the friable mucosa and may result in pain inflicted upon the patient due to the exposed or extruded suture knots.
Additionally, the time required can often exceed 20 minutes for the closure. The same problems are often seen in other procedures performed upon mucosal tissues such as for bowel anastomosis, closure of biopsy wounds, plications of the stomach, etc. This phenomenon is not only limited to mucosal tissue but also other areas where soft tissues are approximated or secured, such as for shoulder plications, etc.
Thus, there is a need for instruments and procedures which allow for the deployment of tissue securement devices which enable the securement of soft tissue regions, particularly in areas of the body where space is limited.
Tissue anchors which are optimally sized for tolerability within a patient's mouth and which are also configured to lock against suture without the need for tying knots or exposing terminal suture lengths. Moreover, such tissue anchors having a low-profile may also reduce any potential irritation associated with knots or suture tails interacting with surrounding tissues. Such tissue anchors may generally comprise an anchor housing which defines a first surface for presentation against a tissue surface, a second surface opposite to the first surface, and a periphery between the first and second surfaces, the anchor housing defining a receiving channel within or along the periphery. A securement member which is adjustably slidable relative to the receiving channel and further defining a suture receiving channel along a portion of the member may also be used such that the suture receiving channel is aligned with an opening defined along the first surface, wherein the securement member and a compression surface along the receiving channel are spaced apart from one another and form a suture compression interface. Additionally, a length of suture may also be used where the suture has a first portion positioned along the suture compression interface and a second portion passed through the suture receiving channel and opening along the first surface, wherein the suture compression interface has a height which is sized to be relatively smaller than a diameter of the first portion of suture.
In an example of using such tissue anchors, one method of loading a length of suture into an anchor may generally comprise providing the anchor housing which defines a first surface for presentation against a tissue surface, a second surface opposite to the first surface, and a periphery between the first and second surfaces, the anchor housing defining a receiving channel within or along the periphery. A length of suture having a first portion and a second portion may be placed within or along a suture receiving channel defined along a portion of a securement member such that the length of suture is partially engaged by the securement member to facilitate handling of the length of suture. The securement member may be adjustably slidable into the receiving channel such that the suture receiving channel is aligned with an opening defined along the first surface. The first portion of suture may be compressed within or along a suture compression interface formed between the securement member and a compression surface along the receiving channel spaced apart from one another, wherein the suture compression interface has a height which is sized to be relatively smaller than a diameter of the first portion of suture, and wherein the first portion of suture passes through the periphery between the first and second surfaces and the second portion of suture passes through the opening along the first surface.
In delivering and deploying the tissue anchors, an anchor delivery assembly may be used which may generally comprise an elongate member having a distal end with a cartridge receiving assembly attached thereto, a cartridge housing detachably insertable into the cartridge receiving assembly, the cartridge housing having at least one translatable member defining a tapered surface at a first end, the cartridge housing further defining a cartridge opening into which one or more tissue anchors are positionable, and a plunger translatable relative to the cartridge housing, wherein actuation of the plunger contacts the tapered surface of the translatable member and urges the translatable member into contact against the one or more tissue anchors, wherein the one or more tissue anchors each comprise an anchor housing which defines a first surface for presentation against a tissue surface, a second surface opposite to the first surface, and a periphery between the first and second surfaces, the anchor housing defining a receiving channel within or along the periphery.
Additionally, the assembly may also include a securement member which is adjustably slidable relative to the receiving channel and further defining a suture receiving channel along a portion of the member such that the suture receiving channel is aligned with an opening defined along the first surface, wherein the securement member and a compression surface along the receiving channel are spaced apart from one another and form a suture compression interface, and a length of suture having a first portion positioned along the suture compression interface and a second portion passed through the suture receiving channel and opening along the first surface, wherein the suture compression interface has a height which is sized to be relatively smaller than a diameter of the first portion of suture.
A length of suture may be configured within the tissue anchor to enter in an axial direction relative to the anchor housing while exiting the anchor housing in a peripheral or lateral direction. As the suture length is passed through the anchor housing, a portion of the suture may be compressed along the lateral direction. Additionally, the anchor may have a male component which may lock into a female receiving channel such that interaction between the male component and female component provides for multiple locations of securement for the suture by the tissue anchor. For instance, the interaction between the male and female components may provide suture securement by providing for a compression length of a portion of the suture, a tortuous passageway through the anchor housing, and a wedged or compressed entry point forcing the suture between the male and female components.
Moreover, the tissue anchors are further designed to provide for increased strength for ensuring suture securement without the anchor housing failing. The ability of the anchor housing to compress the suture within the anchor body may be due in part to the preservation of a uniform structure of the anchor housing. The anchor housing into which the male component is inserted may be designed to preserve a uniform structure along the different planes of the anchor body. That is, no part of the anchor housing may be formed with an opening profile that extends through the entire structure of the anchor housing thus providing for increased strength of the anchor when secured to the suture.
Furthermore, the tissue anchor may be formed to be biodegradable or bioabsorbable such that the tissue anchor may dissolve or become absorbed by the patient's body over a predetermined period of time. The ability of the anchors to be biodegraded or bioabsorbed may provide particular challenges because of the need to hold or secure approximated tissue portions for extended periods of time. Typically, biodegradable or bioabsorbable materials may not provide the sufficient material properties for securing a suture length. However, because of the configuration of the male and female components and the relative interaction between the two, various biodegradable materials may be used to fabricate the tissue anchor, e.g., polylactic acid (PLA), poly-DL-lactide (PHA), polyglycolic acid (PGA), Poly (Î-caprolactone) (PCL), polyether sulfone (PES), polydioxanone (PDS), co-polymers of the materials, etc.
Additional variations of tissue anchors and deployment methods which may be used with the instruments and methods described herein may be found in further detail in U.S. Prov. 61/710,516 filed Oct. 5, 2012 and 61/698,279 filed Sep. 7, 2012, each of which is incorporated herein by reference in its entirety for any purpose.
One variation of an anchor assembly may have the anchor housing formed as a housing which defines an opening along its periphery which opens into a receiving channel extending from the opening and at least partially into or through the anchor housing. The anchor housing may also define a notch or shoulder extending at least partially along the periphery over the opening. The securement member may be configured as a planar member having a width sized to correspond to the receiving channel and having a height which is slightly less than a height of the channel to accommodate a length of suture. The securement member may be slidingly introduced through the opening and into the receiving channel such that a notch at a distal end of the securement member interfits with a member within the housing in a corresponding manner to provide for added stability between the two structures.
The securement member may further define a suture receiving notch extending towards a central portion of the member and having an optional retaining arm extending over the notch to facilitate side-loading insertion of a suture length into the notch prior to locking insertion of the member into the receiving channel.
The anchor housing may be sized into various dimensions so long as the anchor assembly is suitably tolerable for placement within the patient's body, such as within the patient's mouth where the patient is continually exposed to interaction with the anchor housing. Moreover, the anchor housing may be configured into various shapes which may present an atraumatic surface to the surrounding tissue of the patient. In one configuration, the anchor housing may be configured into a circular shape having, e.g., a diameter of 3.5 mm or up to 5.0 mm and a height of 1.5 mm or up to 3.0 mm, although other suitable sizes may be used so long as the anchor housing is able to provide the securement force for the suture.
A first surface may be defined along a portion of the anchor housing which may contact against the tissue surface. The first suture may define a suture locking channel which may extend from the opening along the periphery of the anchor housing and extend along the receiving channel towards a central portion of the anchor housing. A second surface opposite to the first surface may present a planarly uniform and uninterrupted surface for providing additional strength to the anchor housing.
To lock or secure a length of suture to the anchor assembly, a length of suture may be initially inserted into the suture receiving notch defined along the securement member. The securement member may then be inserted into the receiving channel of the anchor housing. Optionally, the securement member may be inserted into the anchor housing through various interfacing mechanisms. For instance, the securement member may comprise a separate component which may be longitudinally inserted into the anchor housing while in other variations, the securement member may be pivotably attached to the anchor housing such that engagement between the two members may be accomplished by rotating the securement member into locking contact within the anchor housing.
As the suture is urged into the anchor housing, a first portion of the suture may be squeezed between the apposed surfaces of the securement member and the receiving channel forming a suture compression interface such that the first portion of suture is compressed along a plane, e.g., parallel to a plane defined by the anchor housing. With the first portion of suture compressed within the suture compression interface of the enclosed anchor assembly, an interference fit may be created between the first portion and the anchor housing.
Moreover, the height of the suture compression interface between the securement member and the receiving channel may be varied by altering the respective dimensions depending upon the desired degree of compression along the suture and the diameter of the suture used. With the variability, the height may be dimensioned to be no greater than 75% of the uncompressed diameter of the first portion of suture in one variation or no greater than 90% of the uncompressed diameter of the first portion in another variation. Additionally, the length of the suture compression interface may also be varied through the anchor housing to range from, e.g., 0.5 mm to 1.75 mm.
With the first portion extending from the opening about the periphery of the anchor housing and along the securement member, the first portion of suture may then curve or bend through the suture receiving notch within the anchor housing such that a second portion of suture passes through the first surface of the anchor housing. The first portion of suture may accordingly be orthogonal to or form an angle with the second portion of suture, e.g., 60 degrees and up to 135 degrees. The suture passes through the first surface along a longitudinal axis of the anchor housing, forms a tortuous passageway around notch, is compressed along the suture compression interface, and then exits along the periphery of the anchor assembly.
To accommodate the second portion of suture passing through the first surface, the anchor housing may define a slot along the first surface which extends from the opening towards a center portion of the anchor housing. The slot may have a width ranging from, e.g., 40% to 50%, of a width or diameter of the anchor housing. When the securement member is urged entirely into the receiving channel, the slot may form an additional compression point with the notch of the securement member against the suture. The resulting compression and pinching of the suture through the anchor housing may result in a resistive pull force upon the suture of 0.125 lb and up to 3.5 lb. Moreover, even with the use of the biodegradable or bioabsorbable materials used in fabricating the anchor assembly, having the second surface present a uniform and continuous surface helps to prevent or inhibit deformation of the anchor housing upon application of the load to the suture which also may help to enable a significant compression locking force at the interface. Additionally, the distal portion of the receiving channel is also configured to limit expansion of the anchor housing upon application of the load upon the suture.
The length of the suture may be initially inserted into notch and then the securement member may be advanced distally into the receiving channel once the suture is ready to be secured. The first portion of suture may become compressed along the suture compression interface formed between the upper surface of the securement member and the apposed inner surface of the receiving channel such that the first portion of suture is compressed to a reduced thickness, e.g., up to 75%, which is less than the uncompressed suture diameter. The first portion of suture may then pass through the notch of securement member such that the second portion of suture passes through the first surface of the anchor housing. The suture may thus be compressed along the interface, secured via the tortuous passageway around notch, and also pinched between the notch and slot defined along the first surface.
In deploying one or more of the tissue anchors described herein, a deployment instrument may be used. The deployment instrument may generally comprise a handle having an actuation plunger attached. An elongate shaft may extend from the handle with a cartridge engagement housing positioned at its distal end. An anchor deployment cartridge may be removably attached to the engagement housing for aligning the tissue anchors to be deployed. Each of the deployment cartridges may contain a single tissue anchor or two or more tissue anchors aligned and engaged for deployment into the tissue region. Once the tissue anchors have been deployed or spent from the deployment cartridge, the cartridge may be ejected from the engagement housing and a new cartridge having additional tissue anchors may be engaged to the housing.
As the cartridge may generally hold one or two tissue anchors, multiple cartridges may be utilized with the deployment instrument, e.g., when suturing a portion of tissue with multiple interrupted sutures. Each individual cartridge may be positioned within a cartridge slot adjacent to one another in a circular manner. The cartridge assembly may be rotated during use to facilitate the insertion of a cartridge into the engagement housing of the deployment instrument.
The individual cartridges positioned upon the assembly may be specially marked or have some visual indicator to optionally indicate the first cartridge to be used and/or a terminal cartridge to be used, if so desired, where the initial cartridge or terminal cartridge may contain a single tissue anchor or specialized tissue anchor. The individual tissue anchors within the initial and/or terminal cartridge may also optionally incorporate some visual indicator, such as coloring, to indicate the initial tissue anchor (e.g., colored green) used in a procedure and/or a terminal tissue anchor (e.g., colored red) used in the procedure.
In suturing and plicating soft tissues, particularly along tissue regions located in areas of the body where space is limited (e.g., gastrointestinal tissues, oropharyngeal, laryngeal, vascular tissues, etc.), tissue anchors which are optimally sized for tolerability within a patient's mouth and which are also configured to lock against suture without the need for tying knots or exposing terminal suture lengths may be used to form a tortuous passageway through the anchor. The instruments and tissue anchors may also produce tissue closures with reduced procedure times, create more durable closures, and create improved patient outcomes with reduced pain and improved healing.
A length of suture may be configured within the tissue anchor to enter in an axial direction relative to the anchor housing while exiting the anchor housing in a peripheral or lateral direction. As the suture length is passed through the anchor housing, a portion of the suture may be compressed along the lateral direction. Additionally, the anchor may have a male component which may lock into a female receiving channel such that interaction between the male component and female component provides for multiple locations of securement for the suture by the tissue anchor. For instance, the interaction between the male and female components may provide suture securement by providing for a compression length of a portion of the suture, a tortuous passageway through the anchor housing, and a wedged or compressed entry point forcing the suture between the male and female components.
Moreover, the tissue anchors are further designed to provide for increased strength for ensuring suture securement without the anchor housing failing. The ability of the anchor housing to compress the suture within the anchor body may be due in part to the preservation of a uniform structure of the anchor housing. The anchor housing into which the male component is inserted may be designed to preserve a uniform structure along the different planes of the anchor body. That is, no part of the anchor housing may be formed with an opening which extends through the entire structure of the anchor housing thus providing for increased strength of the anchor when secured to the suture.
Furthermore, the tissue anchor may be formed to be biodegradable or bioabsorbable such that the tissue anchor may dissolve or become absorbed by the patient's body over a predetermined period of time. The ability of the anchors to be biodegraded or bioabsorbed may provide particular challenges because of the need to hold or secure approximated tissue portions for extended periods of time. Typically, biodegradable or bioabsorbable materials may not provide the sufficient material properties for securing a suture length. However, because of the configuration of the male and female components and the relative interaction between the two, various biodegradable materials may be used to fabricate the tissue anchor, e.g., polylactic acid (PLA), poly-DL-lactide (MLA), polyglycolic acid (PGA), Poly (Î-caprolactone) (PCL), polyether sulfone (PES), polydioxanone (PDS), co-polymers of the materials, etc.
As shown in the top views of
The anchor housing 12 may also define a notch or shoulder 18 extending at least partially along the periphery over the opening 16. The securement member 14 may be configured as a planar member having a width sized to correspond to the receiving channel 26 and having a height which is slightly less than a height of the channel 26 to accommodate a length of suture, as described in further detail herein. The securement member 14 may be slidingly introduced through the opening 16 and into the receiving channel 26 such that a notch 20 at a distal end of the securement member 14 interfits with a member 20′ within the housing 12 in a corresponding manner to provide for added stability between the two structures.
The securement member 14 may further define a suture receiving notch 22 extending towards a central portion of the member 14 and having an optional retaining arm 24 extending over the notch 22 to facilitate side-loading insertion of a suture length into the notch 22 prior to locking insertion of the member 14 into the receiving channel 26.
The anchor housing 12 may be sized into various dimensions so long as the anchor assembly 10 is suitably tolerable for placement within the patient's body, such as within the patient's mouth where the patient is continually exposed to interaction with the anchor housing 12. Moreover, the anchor housing 12 may be configured into various shapes which may present an atraumatic surface to the surrounding tissue of the patient. In one configuration, the anchor housing may be configured into a circular shape having, e.g., a diameter of 3.5 mm or up to 5.0 mm and a height of 1.5 mm or up to 3.0 mm, although other suitable sizes may be used so long as the anchor housing 12 is able to provide the securement force for the suture.
As further shown in the top view of
To lock or secure a length of suture to the anchor assembly 10, a length of suture 30 may be initially inserted into the suture receiving notch 22 defined along the securement member 14. Securement member 14 may then be inserted into the receiving channel 16 of anchor housing 12. As the suture 30 is urged into the anchor housing 12, a first portion 32 of the suture may be squeezed between the apposed surfaces of the securement member 14 and the receiving channel 16 forming a suture compression interface 42 such that the first portion 32 of suture is compressed along a plane, e.g., parallel to a plane defined by the anchor housing 12, as shown in the perspective view of
Moreover, the height of the suture compression interface 42 between the securement member 14 and the receiving channel 16 may be varied by altering the respective dimensions depending upon the desired degree of compression along the suture and the diameter of the suture used. With the variability, the height may be dimensioned to be no greater than 75% of the uncompressed diameter of the first portion 32 of suture in one variation or no greater than 90% of the uncompressed diameter of the first portion 32 in another variation. Additionally, the length of the suture compression interface 42 may also be varied through the anchor housing 12 to range from, e.g., 0.5 mm to 1.75 mm.
Different suture types may react differently to the compressive force imparted upon the first portion 32 of suture. For instance, braided sutures may splay out when compressed. Hence, given the native diameter of the suture used, the suture compression interface 42 height may be generally undersized but having the height improperly sized could potentially bulge or split the anchor housing 12 given the mechanical properties of the biodegradable or bioabsorbable materials used in forming the anchor assembly 10.
With the first portion 32 extending from the opening 16 about the periphery of the anchor housing 12 and along the securement member 16, the first portion 32 of suture 30 may then curve or bend through the suture receiving notch 22 within the anchor housing 12 such that a second portion of suture 34 passes through the first surface 36 of the anchor housing 12. The first portion 32 of suture may accordingly be orthogonal to or form an angle with the second portion 34 of suture, e.g., 60 degrees and up to 135 degrees. The suture 30 passes through the first surface 36 along a longitudinal axis of the anchor housing 12, forms a tortuous passageway around notch 22, is compressed along the suture compression interface 42, and then exits along the periphery of the anchor assembly 10.
To accommodate the second portion 34 of suture passing through the first surface 36, the anchor housing 12 may define a slot 40 along the first surface 36 which extends from the opening 16 towards a center portion of the anchor housing 12. The slot 40 may have a width ranging from, e.g., 40% to 50%, of a width or diameter of the anchor housing 12. When the securement member 14 is urged entirely into the receiving channel 26, the slot 40 may form an additional compression point with the notch 22 of the securement member 14 against the suture 30. The resulting compression and pinching of the suture 30 through the anchor housing 12 may result in a resistive pull force upon the suture of 0.125 lb and up to 3.5 lb. Moreover, even with the use of the biodegradable or bioabsorbable materials used in fabricating the anchor assembly 10, having the second surface 38 present a uniform and continuous surface helps to prevent or inhibit deformation of the anchor housing 12 upon application of the load to the suture 30 which also may help to enable a significant compression locking force at the interface. Additionally, the distal portion of the receiving channel 26 is also configured to limit expansion of the anchor housing 12 upon application of the load upon the suture 30.
As shown in the cross-sectional side view of
In deploying one or more of the tissue anchors described herein, a deployment instrument 60, as illustrated in the perspective view of
As the cartridge 70 may generally hold one or two tissue anchors, multiple cartridges 82 may be utilized with the deployment instrument 60, e.g., when suturing a portion of tissue with multiple interrupted sutures. One variation for facilitating the deployment of multiple tissue anchors may be seen in the perspective view of
The individual cartridges positioned upon the assembly may be specially marked or have some visual indicator to optionally indicate the first cartridge to be used and/or a terminal cartridge to be used, if so desired, where the initial cartridge or terminal cartridge may contain a single tissue anchor or specialized tissue anchor. The individual tissue anchors within the initial and/or terminal cartridge may also optionally incorporate some visual indicator, such as coloring, to indicate the initial tissue anchor (e.g., colored green) used in a procedure and/or a terminal tissue anchor (e.g., colored red) used in the procedure.
With the suture 30 optionally passed through a tissue region T to be approximated, the second tissue anchor 96 may be secured against the length of suture 30 by actuating the plunger 64 such that an actuation member 102 is urged through the engagement housing 68 and into contact against a second sliding member 104. The distal end of actuation member 102 may be angled or tapered and the proximal end of second sliding member 104 may also be angled in a corresponding manner such that when the angled end of member 104 is pressed by actuation member 102, member 104 may slide distally into contact against the first anchor housing 98 to drive the anchor housing 98 and securement member 100 into securement upon the suture 30, as shown in
With the second anchor 96 secured upon the suture 30, anchor 96 may be removed from the retaining stage 76 of cartridge 70, as shown in
In another variation, the cartridge 70 may optionally incorporate a cutting element (not shown for clarity) configured manually or automatically to cut the length of suture 108 extending between each of the anchors 90, 96. Such a cutting element may incorporate any number of severing mechanisms, e.g., blade, wire, energized element, etc., which may be actuated by the actuation member 102 or a separate actuation mechanism.
Another variation of the tissue anchor is illustrated in the perspective and top views of
The length of suture 30 may be initially loaded through the suture receiving slot 122 of securement member 114, as shown in
As the securement member 114 is further rotated into peripheral opening 118, the first portion 32 of suture may become compressed along the suture compression interface 130 formed between the upper surface of securement member 114 and the inner surface of the opening 118, as shown in the perspective and top views of
Moreover, with the securement member 114 fully rotated into engagement within peripheral opening 118, the first portion 32 of suture compressed along the suture compression interface 130 may be further compressed or pinched along the second portion 34 of suture between the interface of slot 122 and slot 120 to provide for further securement to the suture 30, as shown in the perspective views of
These tissue anchors may also have the same or similar dimensions and anchoring characteristics as described herein for other tissue anchor variations. Additionally, the tissue anchors may be fabricated from any of the materials as also described herein.
An example of how multiple tissue anchors may be deployed as illustrated in the perspective view of
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
