Sequential tissue forceps for use in tissue fastening

A sequential surgical forceps is adapted to sequentially grasp tissue on opposed sides of a tissue interface and then present the tissue for capture and closure by a surgical fastening apparatus. The sequential tissue forceps comprises a first arm, a second arm and central arm wherein both the first arm and the second arm are sequentially closed with respect to the central arm. The first arm, second arm and central arm preferably comprise tips having a gripping structure to facilitate tissue capture and retention. The central arm includes structure that defines a mating interface to allow for selective positioning of the sequential tissue forceps and any captured tissue with respect to a surgical fastening apparatus. In this way, the tissue forceps is able to consistently manipulate and present wound tissue relative to the surgical fastening apparatus.

FIELD OF THE INVENTION

The present invention relates generally to the field of surgical instruments such as tissue forceps. More particularly, the present invention relates to a sequential tissue forceps capable of sequentially grasping and approximating opposed sides of a wound with a single instrument that also includes structure that mates with corresponding structure on a surgical fastening apparatus.

BACKGROUND OF THE INVENTION

When an opening in tissue is created either through an intentional incision or an accidental wound or laceration, biological healing of the opening commences through the proximity of the opposed living tissue surfaces. If the opening is very large or if its location subjects the wound to continual movement, a physician will seek to forcibly hold the sides of the opening in close proximity so as to promote the healing process.

A variety of surgical methods and devices are currently employed in forcibly closing and approximating tissue openings throughout the healing process. Examples include the use of elastic skin closures, sutures, staples, adhesive dressings and skin glue. Regardless of their construction or method of use, these wound closure modalities all seek to positively retain living tissue on opposed sides of the opening in closed relation throughout the healing process.

In general, use of the aforementioned wound closure modalities necessitates that a medical professional manipulate and/or approximate opposed sides of the tissue wound prior to and/or during deployment of the wound closure modality. In many situations, the medical professional uses one or more surgical forceps to grasp and retain the tissue during application of the wound closure modality. A typical surgical forceps can comprise a pair of grasping arms that are operably joined at an apex such that arm tips located distally from the apex can be brought into proximity by squeezing the grasping arm together. This typically requires two medical professionals to successfully achieve wound closure; one for tissue approximation and one for fastener deployment. In other alternative configurations such as, for example, configurations disclosed in U.S. Pat. No. 2,214,984 to Bachmann, U.S. Pat. No. 4,950,281 to Kirsch et al., U.S. Pat. No. 5,520,704 to Castro et al., U.S. Pat. No. 5,565,004 to Christoudias and U.S. Pat. No. 6,283,984 to Ray, a surgical forceps can comprise two grasping arms and a central arm such that both sides of tissue wound can be grasped and retained with a single forceps.

One recent advance in the field of wound closure comprises a bilateral wound closure method in which a bioabsorbable fastener is positioned for deployment within target tissue zones, defined within the dermal layers on opposed sides of a wound interface. Once deployed, the bioabsorbable fastener is not externally visible and no follow-up visit is required to remove the fastener once the wound has healed. This bilateral wound closure approach is commercially available as the Insorb® Subcuticular Skin Stapler manufactured by Incisive® Surgical, Inc. of Plymouth, Minn., and is described in U.S. Pat. No. 6,726,705, as well as in a series of pending U.S. patent applications Ser. Nos. 10/448,838 and 10/607,497, all of which are herein incorporated by reference to the extent not inconsistent with the present disclosure.

Through the development of the aforementioned bilateral wound closure approach, it has been discovered that the targeted dermal tissue can have a multitude of variables that effects the ability to effectively approximate tissue for purposes of effecting a wound closure. These variables can comprise thickness, stretch, and strength and can vary based upon the wound's location on the body, the patient's body type as well as the patient's age. As such, it would be advantageous to further improve on the ability to effectively close wounds by having an apparatus and method of implementing said apparatus so as to consistently manipulate and present a wound to a closure instrument.

SUMMARY OF THE INVENTION

The present invention pertains to a sequential surgical forceps adapted to sequentially grasp tissue on opposed sides of a tissue interface. Once grasped in a sequential manner, the tissue can then be presented for capture and closure by a surgical fastening apparatus. The complete procedure of approximation and closure of a tissue wound can be accomplished by a single operator. The sequential tissue forceps comprises a first arm, a second arm and central arm wherein both the first arm and the second arm are sequentially closed with respect to the central arm. The first arm, second arm and central arm preferably comprise tips having an improved gripping surface to facilitate tissue capture and retention. In some embodiments, the central arm comprises a pair of tips wherein a gap is presented between the tips that defines a mating interface to allow for selective positioning of the sequential tissue forceps and any captured tissue with respect to a surgical fastening apparatus. In this way, the present invention is able to consistently manipulate and present wound tissue to the surgical fastening apparatus. In another embodiment, the sequential tissue forceps does not include a defined mating interface on the center arm but still provides for bilateral tissue capture and retention in a sequential manner using the sequential tissue forceps.

In one aspect, the present invention comprises a surgical tissue forceps apparatus having a first arm, a second arm and a central arm. The first arm, second arm and central arm are operably joined at an apex. The first arm and second arm are oriented on opposed sides of the central arm such that a first spring constant with respect to the first arm and the central arm is different from a second spring constant with respect to the second arm and the central arm. By varying the spring constant between the first and second spring constant, the surgical tissue forceps apparatus can be adapted so as to sequentially close the first arm and then the second arm with respect to the central arm. Through such a sequential closure of the first arm and second arm relative to the central arm, tissue on opposed sides of a wound can be sequentially grasped, retained and approximated under selective control of the user operating the present invention.

In one embodiment, the central arm comprises a defined mating interface at the tip portion of the central arm. The interface cavity is adapted to interface with corresponding structure preferably defined on a head portion of a surgical closure instrument so as to present the opposed sides of the tissue wound for closure with the surgical closure instrument.

In another aspect, the present invention comprises a method of sequentially approximating opposed sides of a tissue wound in preparation and anticipation of closing the wound with a surgical fastener. Using a sequential tissue forceps, a first side of a tissue wound is operably grasped and retained. Next, a second side of a tissue wound is operably grasped and retained with the same tissue forceps. Once both the first and second sides of tissue have been captured, the sequential tissue forceps is matingly interfaced with a surgical closure instrument, such that the tissue forceps selectively positions both the first and second sides of tissue with respect to the surgical fastening instrument.

In another aspect, the present invention comprises a wound closure system. The wound closure system comprises a sequential tissue forceps and a surgical closure instrument wherein the sequential tissue forceps is operably adapted so as to interface with the surgical closure instrument such that opposed sides of a tissue wound are grasped, retained and manipulated for consistent presentation of the wound tissue for closure by the surgical closure instrument.

The above summary of the various embodiments of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. The figures in the detailed description that follow more particularly exemplify these embodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As illustrated inFIGS. 1,2,3and4, a sequential tissue forceps100of the present invention can comprise a first arm102, a second arm104and a central arm106. Sequential tissue forceps100can be fabricated of any material suitable for use in a surgical setting such as, for example, stainless steel, carbon fiber, medical grade polymers and combinations thereof. In one representative embodiment, sequential tissue forceps100can be fabricated of 400 series, high chromium stainless steel that has been annealed and tempered to provide desired performance characteristics as will be subsequently described. In some embodiments, sequential tissue forceps100is fabricated of a material capable of repeated sterilization with sterilization equipment such as, for example, an autoclave. Sequential tissue forceps100can be fabricated so as to comprise a unitary structure using a suitable molding or casting process. Alternatively, sequential tissue forceps100can be fabricated by operably joining two conventional forceps using a suitable joining process such as, for example, a welding process, wherein a first forceps comprises the first arm102and a first portion of the central arm106while a second forceps comprises the second arm104and a second portion of the central arm106.

Regardless of fabrication method or material, first arm102, second arm104and central arm106are operably connected at an apex108. First arm102and central arm106define a first grasping angle109awhile second arm104and central arm106define a second grasping angle109b. In one embodiment, sequential tissue forceps100is fabricated such that a first spring constant associated with first grasping angle109ais less than a second spring constant associated with second grasping angle109b. The first spring constant and second spring constant can be selectively chosen and varied during fabrication by varying the thickness of first arm102and second arm104or by varying the angles defined by first grasping angle109aand second grasping angle109bor by varying the material properties such as by selective hardening and tempering of metal. In one presently contemplated embodiment, the first spring constant and second spring constant are imparted to sequential tissue forceps100by casting the sequential tissue forceps from 400 series high-chromium stainless steel, stress relieving the forceps by application of heat up to about 2500° C., slowly cooling the forceps, tempering the forceps by application of heat to about 600° C. to restore hardness followed by an immediate quenching of the forceps in liquid nitrogen. In addition to providing for the first and second spring constants and material hardness, suitable fabrication techniques of the preferred embodiment impart a non-scissoring action on the first arm102, second arm104and central arm106such that the movement of the various arms preferably resides substantially within a common plane, thereby maintaining lateral stability during normal use and avoiding any significant overlap and/or misalignment of the arm tips when the arm tips are approximated.

Alternatively, or in addition to varying the first and second spring constants through selective fabrication, a compressible member110can be fixedly mounted, for example, between second arm104and central arm106such that it spans at least a portion of the second grasping angle109bas illustrated inFIGS. 5aand5b. Compressible member110can comprise any of a variety of alternative configurations such as, for example, a leaf spring111aas seen inFIG. 5aor a compressible polymer111bas seen inFIG. 5b. Compressible member100can further comprise other suitable configurations such as, for example, a compression spring, a torsion spring and the like. In some representative embodiments, compressible member110can comprise materials of construction capable of surviving a sterilization and/or autoclaving procedure such as, for example, stainless steel. While a single compressible member110is described and depicted inFIGS. 5aand5b, it will also be recognized that a pair of compressible members110possessing differing compression properties can be utilized, to achieve different effective spring constants associated with the grasping angles109aand109b. It will also be recognized that a plurality of compressible members110may be used within each of the grasping angles109a,109b, either longitudinally along the arms102,104or106or stacked there between.

First arm102is generally defined by a first tip112and a first interconnecting end114. First arm102can preferably include a first grip enhancement116on a first manipulation surface118. First grip enhancement116can comprise a variety of suitable surface treatments for promoting an operator's grip such as, for example, machined or molded ridges, grooves and other friction enhancers or the application of a grippable rubber or rubber-like polymer. First tip112similarly can include a first gripping member120on a first interior surface121selected to enhance the gripping capability of the first arm102with respect to tissue capture. First gripping member120can comprise any of a variety of gripping shapes and structures including a projecting member, a piercing member and/or surface treatments such as, for example, machined or molded ridges, grooves and other friction enhancers or the application of a grippable rubber or rubber-like polymer.

In another embodiment, second arm104is constructed to resemble first arm102such that the second arm104is defined by a second tip122and a second interconnecting end124. Second arm104preferably can include a second grip enhancement126on a second manipulation surface128. Second grip enhancement126can substantially resemble first grip enhancement116and may comprise suitable surface treatments such as, for example, machined or molded ridges, grooves and other friction enhancers or the application of a grippable rubber or rubber-like polymer, as previously described with respect to first grip enhancement116. Second tip122can include a second gripping member130on a second interior surface131substantially resembling first gripping member120wherein said second tip122is selected to enhance the gripping capability of the second arm104with respect to tissue capture. Second gripping member130can comprise any of a variety of gripping shapes and structures including a projecting member, a piercing member and/or surface treatments such as, for example, machined or molded ridges, grooves and other friction enhancers or the application of a grippable rubber or rubber-like polymer.

Central arm106is generally defined by a tip portion132and a central interconnecting end134. In one representative embodiment, tip portion132comprises a pair of dual tips136a,136bseparated by a mating interface138. Mating interface138is generally defined by an interface width140, an interface depth142and an interface wall143. Dual tips136a,136bpreferably each comprise a central tip gripping surface144a,144bsimilar to gripping surface120and second gripping surface130.

In operation, a medical professional preferably grasps and operates the sequential tissue forceps100with a single hand. During use and operation of sequential tissue forceps100, the medical professional generally squeezes and manipulates sequential tissue forceps100between an open disposition146as illustrated inFIG. 6, a partially-closed disposition148as illustrated inFIG. 7and a fully-closed disposition150as illustrated inFIG. 8.

With respect to the open disposition146shown generally inFIG. 7, the sequential tissue forceps100assumes and remains in open disposition146at all times in which a squeezing bias is not introduced on the first arm102and second arm104including times prior to and following use such as, for example, shipment, storage, sterilization and disposal. Generally, open disposition146is maintained through the selection of first and second spring constants having a minimum value so as to define minimum compression forces required to direct either the first arm102or second arm104into proximity with central arm106. In one presently preferred embodiment, a minimum compression force for directing either first arm102or second arm104into proximity with central arm106exceeds at least about 0.5 pounds and more preferably, exceeds about 0.6 pounds. By having a minimum compression force exceeding at least about 0.5 pounds, closure of either first arm102or second arm104into proximity with central arm106must be accomplished through a squeezing action by a user as opposed to collapsing or closing by itself.

With respect toFIG. 7depicting the partially-closed disposition148, first arm102is described as approaching central arm106in the following discussion though it will be understood that the discussion is relevant to second arm104as well as either first arm102or second arm104can approach central arm106depending upon which of the first and second spring constants is less. Squeezing first arm102and second arm104with a compression force exceeding the minimum compression force defined by the first spring constant, and assuming that the first spring constant is less than the second spring constant, results in first tip112approaching dual tip136asuch that first tip112and dual tip136aare either in contact or in close physical proximity. During this initial squeezing of first arm102and second arm104, second arm104remains generally stationary and set apart from central arm106as the initial compression force exceeds only the first spring constant. The initial compression force to achieve partially-closed disposition148preferably, exceeds about 0.5 pounds as previously discussed and preferably does not exceed about 1.0 pounds.

Once first arm102has been fully squeezed such that first tip112is in abutting contact and/or proximity with the dual tip136a, further squeezing on the first arm102and second arm104in excess of the second compression force defined by the second spring constant effectively causes second tip122to approach dual tip136bso as to assume fully-closed disposition150as illustrated inFIG. 8. The second spring constant preferably defines the second compression force so as to be accomplished with a squeezing force that can be easily accomplished by a medical professional. For example, a suitable second compression force can range from about 1.0 pounds to about 2.0 pounds, and more preferably ranges from about 1.5 pounds to about 1.85 pounds. In the embodiment in which second arm104includes compression member110, the further squeezing causes compression of the compressible member110as part of this process. Through such continued, further squeezing, second tip122approaches and ultimately contacts the dual tip136b. When fully squeezed, first tip112and second tip122preferably are maintained and spaced apart by at least the interface width140plus any additional thickness from captured tissue.

When selecting the first compression force and second compression forces, several factors must be considered. First, the required compression forces should be high enough that neither the first arm102nor second arm104close by themselves when not in use to grasp tissue. In addition, the required compression forces should be high enough that tissue can be retained between either the first arm102and central arm106or between the second arm104and central arm106such that the sequential forceps100can be repositioned to grasp tissue apart from and/or opposed to the tissue which is already grabbed. However, the required compression forces should not be so high as to require compression forces that would lead to tissue damage with captured tissue or to cause operator fatigue during use. Preferably, the compression forces selected for the second compression force and the first compression force are selectively chosen such that a ratio of the second compression force to the first compression force ranges from about 1.5:1 to about 3.5:1, and more preferably from about 2:1 to about 3:1.

In one embodiment, the sequential tissue forceps100can provide for unique advantages relative to wound closure methods such as, for example, bilateral wound closure methods performed utilizing the Insorb® Subcuticular Skin Stapler available from Incisive® Surgical, Inc., of Plymouth, Minn., and as described in U.S. Pat. No. 6,726,705 and U.S. Patent Publications Nos. 2002/0111641A1, 2003/0236551A1, 2004/0059377A1 and 2005/0085857A1, all of which are herein incorporated by reference in their entirety.

A representative skin fastening system200as illustrated inFIGS. 9 and 10can comprise sequential tissue forceps100and a skin stapler202. In one preferred embodiment, skin stapler202can comprise the afore referenced Insorb® Subcuticular Skin Stapler. As illustrated inFIG. 9, operation of skin fastening system200can be accomplished with a single medical professional with the medical professional manipulating the sequential tissue forceps100with a first hand204and the skin stapler202with a second hand206. With reference toFIGS. 9 and 10, skin stapler202can comprise an insertion head208having a nested capture region210adapted to receive the mating interface138for positioning the tip portion132relative to the insertion head208.

As shown inFIGS. 11,12,13and14, skin fastening system200can be utilized to close a skin tissue wound300. Initially, sequential tissue forceps100is positioned proximate to the tissue wound300. Tissue wound300is generally defined by a tissue opening302, a first tissue side304and a second tissue side306. As described and illustrated, skin tissue wound300is externally located with reference to the human body, i.e., the skin. However, it will be understood by one of skill in the art that use and operation of the skin fastening system200and sequential tissue forceps100is not limited to skin wounds, closed either with external or subcuticular closure modalities, but can be similarly utilized to close internal wounds or to position or maintain tissue and/or organ positions internal to the human body.

In a first operational step as shown inFIG. 11, sequential tissue forceps100is positioned in proximity to the first tissue side304such that tip portion132is located in the tissue opening302with the first tip112positioned external to the wound300, and more specifically, external to first tissue side304. An initial squeezing force exceeding at least about 0.5 pounds is applied to the first arm102and second arm104by first hand204such that the first tip112approaches or closes with respect to the dual tip136a. As described previously, second tip122does not at this time approach the dual tip136bdue to the increased spring constant of the second spring constant between the second arm104and the central arm106such that sequential tissue forceps100assumes partially-closed disposition148. As first tip112approaches dual tip136a, first tissue side304is captured and retained between first tip112and dual tip136a. First tip112, first gripping member120, dual tip136aand central tip gripping surface144acooperatively retain first tissue side304as long as the compression force applied to first arm102and second arm104exceeds about 0.5 pounds.

Following the capture of first tissue side304, tip portion132is positioned proximate the second tissue side306such that the second tip122is positioned external to second tissue side306as shown, while first tissue size304remains captured between first tip112and dual tip136a. As the tip portion132is repositioned with respect to the second tissue side306, the initial compression force used to capture the first tissue side304is maintained. Once the sequential tissue forceps100is properly positioned with respect to the second tissue side306, the compression force applied to first arm102and second arm104is increased to an amount sufficient to overcome the second spring constant, generally between about 1.0 to about 2.0 pounds, between the second arm104and central arm106. The increased compression force directs second tip122toward dual tip136b. As second tip122approaches dual tip136b, second tissue306is captured and retained as the sequential tissue forceps100assumes fully-closed disposition150as illustrated inFIG. 12. Second tip122, second gripping member130, dual tip136band central tip gripping surface144bcooperatively retain second tissue side306as long as the compression force applied to first arm102and second arm104exceeds about 1.0 pounds. When second tip122has been closed with respect to the dual tip136b, first tissue side304and second tissue side306are retainably captured on opposed sides of the tip portion132at a distance only slightly exceeding interface width140.

Upon retainable capture of the first tissue side304and second tissue side306by the sequential tissue forceps100, a medical professional is able to maintain the grip and positioning of first tissue side304and second tissue side306with a single hand, for example, first hand204. At this point, the medical professional may utilize second hand206to retainably join first side304and second side306with a surgical fastener such as, for example, a fastener, a staple, a suture, steri-strips, an adhesive bandage and skin glue, used either individually or in combination, to retainably close tissue opening302so as to promote healing of wound300. Alternatively, a second medical professional may assist in the surgical closure process.

As illustrated inFIGS. 13 and 14, the medical professional can utilize the skin stapler202, depicted as the Insorb® Subcuticular Skin Stapler, to close the wound300. The insertion head208is positioned generally within the tissue opening302. Insertion head208is positioned so as to reside generally below the captured first tissue side304and second tissue side306. In this embodiment, the medical professional orients and positions the sequential tissue forceps100, while still retaining first tissue side304and second tissue side306, such that the mating interface138is slidably positioned into the nested capture region210. When the mating interface138is positioned over the nested capture region210, the mating interface138preferably is in abutting relation to the nested capture region210along the length of interface depth142such that the interface wall143is in physical contact with the insertion head208. Through the interaction of nested capture region210and mating interface138including precise dimensioning of interface width140and interface depth142, a point of tissue presentation is adjustably variable with respect to where the first tip112, second tip122and dual tips136a,136b, are located with respect to the insertion head208when the sequential tissue forceps100and skin stapler202are fully nested as shown inFIG. 14.

Varying the point of tissue presentation with respect to the skin stapler202is especially advantageous due to differences in tissue thickness and stretch which can vary depending upon placement on the body such as, for example, the head region versus the stomach region, or based upon the body type of the patient such as, for example, male versus female, obese versus underweight, and the like.

Once first tissue side304and second tissue side306have been retainably positioned with respect to the insertion head208, a fastener such as, for example, a dynamic bioabsorbable fastener as taught by U.S. Patent Publications Nos. 2004/0059378A1 and 2005/0182444A1, both of which are herein incorporated by reference in their entirety, is deployed by the skin stapler202to capture first side304and second side306so as to at least partially close wound300. In addition or as an alternative, a complimentary fastener device such as, for example, a suture, an adhesive skin closure such as Steri-Strip™ brand closures available from Minnesota Mining and Manufacturing of Maplewood, Minn., an adhesive bandage such as Band-Aid® brand adhesive bandages available from Johnson & Johnson of New Brunswick, N.J., and skin glue such as Dermabond® brand liquid stitches available from Ethicon, Inc, a Johnson & Johnson company, can be applied to cooperatively maintain the closure of wound300.

In another aspect of the present invention, skin stapler202and more specifically, insertion head208can be further adapted to promote the ability to selectively vary the point of tissue presentation between the sequential tissue forceps100and skin stapler202. In one representative example shown inFIG. 15, insertion head208can be configured so as to provide a multiplicity of staged receiving portions212a,212b,212c, each capable of individually, slidably interfacing with mating interface138and interface wall143. Using sequential tissue forceps100, a medical professional can capture first tissue side304and second tissue side306as previously described. The medical professional can then position the skin stapler202such that the insertion head208resides within the tissue opening302as previously described. Based upon factors such as, for example, professional experience and tissue variables such as thickness and conditions, the medical professional can determine the desired depth of tissue presentation with respect to where the first tip112, second tip122and dual tips136a,136bposition the first tissue side304and second tissue side306with respect to the insertion head208. For example, abuttably positioning receiving portion212aagainst interface wall143results in first tissue side304and second tissue side306being positioned at a deepest position relative to the insertion head208. Similarly, abuttably positioning receiving portion212bagainst interface wall143results in first tissue side304and second tissue side306being positioned at an intermediate depth relative to the insertion head208while abuttably positioning receiving portion212cagainst interface wall143results in first tissue side304and second tissue side306being positioned at a shallowest position within the insertion head208. The medical professional can selectively choose the depth of tissue presentation within the insertion head208based upon personal experience and preference as well as a variety of application or tissue related factors such as, for example, placement on the body such as, for example, the head region versus the stomach region, skin versus organ, wound retention versus tissue positioning or based upon the body type of the patient such as, for example, young versus old, male versus female, obese versus underweight, and the like.

In another aspect of the invention, use of the skin fastening system200can be promoted through configuration of the skin stapler202for consistent placement and presentation of the first tip112, second tip122and dual tips136a,136brelative to the insertion head208. As illustrated inFIGS. 16aand16b, insertion head208can comprise a pair of positioning guides214a,214bon either side of a divider wall216. The positioning guides214a,214bcan each comprise a funnel-like receiving area218comprising a cut-away receiving portion220, a guiding portion222and an abutment portion224. Generally, the cut-away receiving portions220are positioned such that a top width of the divider wall216is less than the interface width140of the mating interface138so as to allow a medical professional to position the mating interface138, and corresponding any tissue captured by the first tip112, second tip122and dual tips136a,136bin the proper position and orientation with respect to the insertion head208. The medical professional can then direct the mating interface138such that the interface wall143comes into abutting contact with divider wall216to position the tissue and first tip112, second tip122and dual tips136a,136bat the proper fastening depth for skin stapler202along a Y plane defined through the midpoints of the positioning guides214a,214bas illustrated inFIG. 15. As the interface wall143approaches the divider wall216, the dual tips136a,136bcontact the guiding portion222and abutment portion224along the interface depth142wherein the guiding portion222and abutment portion224position the tissue captured by first tip112, second tip122and dual tips136a,136bat a proper spaced apart distance along a Z plane wherein the Z plane is transversely oriented to an X plane defined through the center of divider wall216. To further promote tissue positioning with respect to the insertion head208, a pair of capture arms226a,226bcan be attached to the skin stapler202for capturing, gripping and positioning tissue with respect to the insertion head208. As illustrated inFIG. 17, each of the capture arms226a,226bcan comprise an access region228and a gripping region229having a plurality of gripping member230shown inFIG. 17, or alternatively, ridges and other similar gripping arrangements to assist with maintaining tissue position relative to the positioning guides214a,214b. As illustrated inFIG. 18, another alternative embodiment of gripping head208can comprise an interface shelf231on divider wall216wherein the mating interface138is positionable over the interface shelf231for positioning tissue captured by first tip112, second tip122and dual tips136a,136bin the proper position and orientation with respect to the insertion head208.

Although the present invention has been described with respect to the various embodiments, it will be understood that numerous insubstantial changes in configuration, arrangement or appearance of the elements of the present invention can be made without departing from the intended scope of the present invention. Accordingly, it is intended that the scope of the present invention be determined by the claims as set forth.