Dual hypotube suture cutting device and methods

A tissue puncture closure device includes an anchor, a sealing pad, a compaction member, a suture, and a suture cutting member. The compaction member is configured to compress the sealing pad toward the anchor. The compaction member includes a sidewall and a first aperture defined in the sidewall. The suture cutting member is positioned in the compaction member and includes a suture cutting member sidewall and a second aperture defined in the suture cutting member sidewall. The suture is coupled to the sealing pad and anchor, and a portion of the suture extends through the first and second apertures. Relative movement between the compaction member and the suture cutting member severs the suture.

TECHNICAL FIELD

The present disclosure relates generally to medical devices and more particularly to tissue puncture closure devices.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly or intraluminally. For example, in the treatment of vascular disease, such as arteriosclerosis, it is a common practice to invade the artery and insert an instrument (e.g., a balloon or other type of catheter) to carry out a procedure within the artery. Such procedures usually involve the percutaneous puncture of the artery so that an insertion sheath may be placed in the artery and thereafter instruments (e.g., catheters) may pass through the sheath to an operative position within the artery. Intravascular and intraluminal procedures unavoidably present the problem of stopping the bleeding at the percutaneous puncture after the procedure has been completed and after the instruments (and any insertion sheaths used therewith) have been removed. Bleeding from puncture sites, particularly in the case of femoral arterial punctures, is typically stopped by utilizing tissue puncture closure devices, such as those described in U.S. Pat. Nos. 6,090,130 and 6,045,569, which are hereby incorporated in their entireties by this reference.

Prior closure devices, such as the ones described in the above-mentioned patents, place a sealing pad at the tissue puncture site. Deployment of the sealing pad involves ejecting the pad from within a device sheath and compacting the pad down to an outer surface of the tissue puncture using a compaction member. After the sealing pad has been compressed against the tissue puncture, the suture is manually cut by the operator at a location outside of the patient.

SUMMARY

One aspect of the present disclosure relates to a tissue puncture closure device that includes an anchor, a sealing pad, a compaction member, a suture, and a suture cutting member. The compaction member is configured to compress the sealing pad toward the anchor. The compaction member includes a sidewall and a first aperture defined in the sidewall. The suture cutting member is positioned in the compaction member and includes a suture cutting member sidewall and a second aperture defined in the suture cutting member sidewall. The suture is coupled to the sealing pad and anchor, and a portion of the suture extends through the first and second apertures. Relative movement between the compaction member and the suture cutting member severs the suture.

At least one of compaction member and the suture cutting member may define a cutting surface at the first and second apertures, respectively. The suture cutting member may be configured to cut the suture at a location within a percutaneous incision of a patient. One of the compaction member and the suture cutting member may include a channel feature extending axially from the first and second apertures, respectively. The compaction member may include a slot feature extending from the first aperture in a proximal direction. The suture cutting member may be rotatable relative to the compaction member to sever the suture.

At least one of the compaction member and the suture cutting member may include an overmold feature positioned between the compaction member and the suture cutting member. At least one of the compaction member and the suture cutting member may include a locking feature, wherein the locking feature is operable to releaseably connect the compaction member to the suture cutting member. At least one of the compaction member and the suture cutting member may include a circumferentially arranged channel feature configured to retain a wrapped portion of the suture.

Another aspect of the present disclosure relates to a suture cutting assembly adapted for use with a tissue puncture closure device. The suture cutting assembly includes a compaction member having a first aperture defined in a sidewall thereof, and a suture cutting member having a second apertures defined in a sidewall thereof. At least a portion of the suture cutting member is positioned in the compaction member. The first and second apertures are arranged to provide passage of a suture through the first and second apertures. Moving the suture cutting member relative to the compaction member cuts the suture.

Axially moving the suture cutting member in a first direction relative to the compaction member may apply a force to the suture to limit movement of the suture relative to the compaction member, and moving the suture in a second direction opposite the first direction cuts the suture. The first aperture may extend from a point proximal of a distal end of the compaction member to a proximal end of the compaction member. At least one of the compaction member and the suture cutting member may define a channel extending in a proximal direction from the first and second apertures, respectively. The first and second apertures may be at least partially radially aligned.

A further aspect of the present disclosure relates to a method of sealing a tissue puncture in an internal tissue wall that is accessible through a percutaneous incision. The method may include providing a tissue puncture closure device having an anchor, a sealing pad, a suture coupled to the anchor and the sealing pad, a compaction member, and a suture cutting device. The compaction member includes a first aperture defined in a sidewall thereof, the suture cutting member includes a second aperture defined in a sidewall thereof, and the suture extends through the first and second apertures. The method may also include inserting the tissue puncture closure device into the percutaneous incision, advancing the anchor through the tissue puncture, compressing the sealing member within the percutaneous incision, and moving the suture cutting device relative to the compaction member to cut the suture at a location within the percutaneous incision.

Moving the suture cutting device relative to the compaction member may include axially moving the suture cutting device relative to the compaction member. Moving the suture cutting device relative to the compaction tube may include rotating the suture cutting device relative to the compaction member. The method may also include positioning the suture in a channel defined between the compaction member and the suture cutting device. The method may further include maintaining tension in the suture by contacting the suture between a surface of the compaction member and a surface of the suture cutting device. The method still further may include providing at least one of the compaction member and the suture cutting device with an overmold feature that is positioned between the compaction member and the suture cutting device, wherein the overmold feature resists relative axial movement between the compaction member and the suture cutting device.

Additional advantages and novel features will be set forth in the description which follows or can be learned by those skilled in the art through reading these materials or practicing the examples disclosed herein.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are conducted throughout the world and require access to a vessel through a puncture. Often, the vessel is a femoral artery. To close the puncture following completion of the procedure, many times a closure device is used to sandwich the puncture between an anchor and a sealing pad. A suture may be used to couple together the anchor and sealing pad. A force may be applied along the suture to draw the anchor and sealing pad toward each other as the sealing pad is compressed against the puncture. Typically, the suture is manually cut at a location outside of the patient after confirmation that the puncture has been sealed. Cutting the suture releases the anchor and sealing pad from the remaining portions of the closure device. A free end of the suture may extend from the patient's skin. Leaving a length of suture protruding through the patient's skin surface may result in complications such as, for example, infections that may arise where the suture exits the patient's skin. Further, requiring the extra step of manually cutting the suture with an instrument separate from the closure device requires additional time and complexity to the procedure.

The present disclosure describes methods and apparatus that facilitate cutting of the suture using features that are integral with the closure device. The present disclosure further describes methods and apparatus that facilitate cutting of the suture within a percutaneous incision at a location below the patient's outer skin surface. While the vascular instruments shown and described below include procedure sheaths and puncture sealing devices, the application of principles described herein are not limited to the specific devices shown. The principles described herein may be used with any medical device. Therefore, while the description below is directed primarily to arterial procedures and certain embodiments of a tissue puncture closure device, the methods and apparatus are only limited by the appended claims.

As used in this specification and the appended claims, the term “compact” or “compacting” is used broadly to mean any type of tamping (i.e., packing down by one or a succession of blows or taps or smooth, steady pressure, but not by excessive force), compacting, or compressing. “Engage” and “engabable” are also used broadly to mean interlock, mesh, or contact between two structures or devices. Likewise “disengage” or “disengagable” means to remove or capable of being removed from interlock, mesh, or contact. A “tube” is an elongated device with a passageway. The passageway may be enclosed or open (e.g., a trough). A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel. The words “including” and “having,” as used in the specification, including the claims, have the same meaning as the word “comprising.”

Referring toFIGS. 1-5, a tissue puncture closure device100is shown according to the prior art. Some example closure devices in addition to tissue puncture closure device100that may be suited for use with the inventive principles described herein are disclosed in U.S. Published Patent Application No. 2005/0085851 and U.S. Pat. Nos. 7,618,438 and 7,618,436, which applications are hereby incorporated in their entireties by this reference. The tissue puncture closure device100includes a carrier tube102with a filament or suture104extending at least partially therethrough. The tissue puncture closure device100also includes a first or proximal end106and a second or distal end107. External to a second or distal end107of the carrier tube102is an anchor108. The anchor is an elongated, stiff, low profile member including an eye109formed at the middle. The anchor108is typically made of a biologically resorbable polymer.

The suture104is threaded through the anchor108and back to a collagen pad110. The collagen pad110may be comprised of randomly oriented fibrous material bound together by chemical means. The collagen pad110is slidingly attached to the suture104as the suture passes distally through the carrier tube102, but as the suture traverses the anchor108and reenters the carrier tube102, it is securely slip knotted proximal to the collagen pad110to facilitate cinching of the collagen pad110when the tissue puncture closure device100is properly placed and the anchor108deployed (seeFIG. 4).

The carrier tube102typically includes a compaction member112disposed therein. The compaction member112is slidingly mounted on the suture104and may be used by an operator to compact the collagen pad110toward the anchor108at an appropriate time to seal a percutaneous tissue puncture.

Prior to deployment of the anchor108within a vessel, the eye109of the anchor108rests outside the distal end107of the carrier tube102. The anchor108may be temporarily held in place flush with the carrier tube102by a bypass tube114disposed over the distal end107of the carrier tube102.

The flush arrangement of the anchor108and carrier tube102allows the anchor108to be inserted into a procedure sheath such as insertion sheath116as shown inFIGS. 2-4, and eventually through an arterial puncture118. The insertion sheath116is shown inFIGS. 2-4inserted through a percutaneous incision119and into a vessel128. However, the bypass tube114(seeFIG. 1) includes an oversized head120that prevents the bypass tube114from passing through an internal passage of the insertion sheath116. Therefore, as the tissue puncture closure device100is inserted into the insertion sheath116, the oversized head120bears against a surface122of insertion sheath116.

Further insertion of the tissue puncture closure device100results in sliding movement between the carrier tube102and the bypass tube114, and releases the anchor108from the bypass tube114(seeFIG. 1). However, the anchor108remains in the flush arrangement shown inFIG. 1following release from the bypass tube114, limited in movement by the insertion sheath116.

The insertion sheath116includes a monofold124at a second or distal end126thereof. The monofold124acts as a one-way valve to the anchor108. The monofold124is a plastic deformation in a portion of the insertion sheath116that elastically flexes as the anchor108is pushed out through the distal end126of the insertion sheath116. Typically, after the anchor108passes through the distal end126of the insertion sheath116and enters the vessel128, the anchor108is no longer constrained to the flush arrangement with respect to the carrier tube102and it deploys and rotates to the position shown inFIG. 2.

Referring next toFIGS. 3-4, with the anchor108deployed, the tissue puncture closure device100and the insertion sheath116are withdrawn together, ejecting the collagen pad110from the carrier tube102into the percutaneous incision119and exposing the compaction member112. With the compaction member112fully exposed as shown inFIG. 4, the collagen pad110is manually compacted, and the anchor108and collagen pad110are cinched together and held in place with the self-tightening slip-knot on the suture104. Thus, the tissue puncture is sandwiched between the anchor108and the collagen pad110, thereby sealing the arterial puncture118. The suture104is then cut and the percutaneous incision119may be closed. The suture104, anchor108, and collagen pad110are generally made of resorbable materials and therefore remain in place while the arterial puncture118heals.

It may be difficult to eject and compact the collagen pad110using the typical tissue puncture closure device100described above. The insertion sheath116resists deformation as the collagen pad110is ejected from the carrier tube and compacting cannot commence until the insertion sheath116has been removed so as to expose the compaction member112for manual grasping. Under certain conditions, removal of the insertion sheath116prior to compacting the collagen pad110causes the collagen pad110to retract or displace proximally from the arterial puncture118, creating an undesirable gap121between the collagen pad110and the arterial puncture118. The gap may remain even after compacting as shown inFIG. 4, and sometimes results in only a partial seal and bleeding from the arterial puncture118.

FIG. 5illustrates cutting of the suture104after compacting of the collagen pad110is completed. Typically, the suture104is cut using a cutting instrument115that is separate and distinct from the tissue puncture closure device100. A free or cut end105of the suture104is located outside of the percutaneous incision119. Thus, the suture104passes through an outer skin surface121.

The general structure and function of tissue closure devices used for sealing a tissue puncture in an internal tissue wall accessible through an incision in the skin are well known in the art. Applications of closure devices including those implementing principles described herein include closure of a percutaneous puncture or incision in tissue separating two internal portions of a living body, such as punctures or incisions in blood vessels, ducts or lumens, gall bladders, livers, hearts, etc.

Referring now toFIGS. 6 and 7, another example tissue puncture closure device200is shown and described. The tissue puncture closure device200includes a carrier tube202, an anchor208, a sealing pad210, a compaction member212, and a suture204. The suture204is coupled to the anchor208and sealing pad210. After compaction of the sealing pad210towards the anchor208with the compaction member212, the suture204may be cinched against the sealing pad210to maintain the sealing pad210in a compacted state.

During the operation of the tissue puncture closure device200, the anchor208, sealing pad210, suture204, and compaction member212are all positioned within the carrier tube202, such as the arrangement of similar components of tissue puncture closure device100shown inFIG. 1. Tissue puncture closure device200is inserted into the percutaneous incision119and the anchor208is advanced through the arterial puncture118into the vessel128. The tissue puncture closure device200is retracted proximally until the anchor208engages against an inner surface of the vessel128adjacent to the arterial puncture118. The carrier tube202is retracted to expose the sealing pad210within the percutaneous incision119. In some arrangements, the compaction member212is then advanced distally in the direction D to compact the sealing pad210toward the anchor208into the compacted state shown inFIG. 7. As mentioned above, the suture204may be cinched against the sealing pad210to help maintain the sealing pad210in a compacted state and coupled to the anchor208.

In at least some circumstances, it may be desirable to cut the suture204at a location within the percutaneous incision119and maintain a cut end of the suture204within the percutaneous incision119. It may also be desirable to cut the suture204using features of the tissue puncture closure device200as opposed to an additional cutting device such as the scissors shown inFIG. 5, a scalpel, or other cutting device that the operator must handle separate from the tissue puncture closure device.

Tissue puncture closure device200may further include a suture cutter device270, which alone or in combination with the compaction member212, is capable of cutting the suture204within the percutaneous incision119. In one arrangement, the suture cutter device270is sized and constructed to operate internal of the compaction member212. The compaction member212may include a lumen or cavity250, a distal end opening252, a distal end portion253, a first aperture254, a side wall256, and a proximal end portion258. The distal end opening252is positioned at the distal end portion253and faces in a generally axial direction toward the sealing pad210. The first aperture254is defined in the side wall256at a location spaced proximal of the distal end opening252. The first aperture254may include a distal end260and a proximal end262. A portion of the first aperture254may define a cutting surface. In at least one example, the distal end260defines a cutting surface configured to cut the suture204. The lumen250may be sized to receive at least portions of the suture cutter device270. In some arrangements, the lumen250may have a variable sized internal dimension along at least a portion of the length of the compaction member212. The lumen250may also be sized to receive portions of the suture204for at least the distal end opening252to the first aperture254.

A compaction member212may have a maximum outer dimension that is less than a minimum internal dimension of the carrier tube202. A space defined between an outer surface of the compaction member212and the inner surface of the carrier tube202may be sized great enough to permit passage of the suture204therebetween along at least a portion of the length of the compaction member212proximal of the first aperture254. In at least some arrangements, the suture204may extend proximally within the carrier tube202into a handle portion (not shown) in the tissue puncture closure device where an excess length of the suture is spooled or managed in other ways. The tissue puncture closure device200may apply tension to the suture204while compacting the sealing pad210.

The suture cutter device270includes a lumen272, a distal end opening274, a distal end portion276, a second aperture278and a proximal end portion277(seeFIGS. 8 and 9). The distal end opening274is defined in the distal end portion276and faces in a generally axial direction towards the sealing pad210. The second aperture278is defined in a side wall279of the suture cutter device270at a location proximal of the distal end opening274. The lumen272is sized to receive the suture204. The lumen272extends from at least the distal end opening274to the second aperture278to provide a pathway for the suture204to pass through the suture cutter device270.

The second aperture278includes a distal end280, a proximal end282, and a cutting surface288(seeFIGS. 8 and 9). The cutting surface288may be defined along any portion of the second aperture278. In at least the embodiment shown inFIGS. 8 and 9, the cutting surface288is defined at the distal end280. Referring toFIG. 9, the cutting surface288is shown having a pointed edge along the distal end280and the internal surface of the lumen272. In other arrangements, the cutting surface may be defined along the exterior surface of the suture cutter device270along an edge of the second aperture278. Many other shapes, sizes, and constructions for the second aperture278and the cutting surface associated with the second aperture are possible in other arrangements.

Referring again toFIG. 6, the first and second apertures,254,278may be aligned radially and axially to provide a pathway for the suture204to travel from within the lumen272to a position outside of the compaction member212. The path of the suture204extends from the anchor208, through the sealing pad210into the distal end opening252of the compaction member212, into the distal end opening274of the suture cutter device270, through the second aperture278, through the first aperture254, and into the space defined between the inner surface of the carrier tube202and the outer surface of the compaction member212.

The suture204may be cut by moving the compaction member212and suture cutter device270axially relative to each other. In one configuration in which the cutting surface288is positioned at the distal end280of the second aperture278, moving the suture cutter device270in the proximal direction P relative to the compaction member212captures the suture204between the cutting surface288and the proximal end262of the first aperture254, which results in cutting of the suture204. In arrangements where cutting surfaces are defined along the distal or proximal end260,262of the first aperture254or along the distal and proximal ends280,282of the second aperture278, relative axial movement (i.e., distal or proximal movement) between the compaction member212and suture cutter device270may result in cutting of the suture204.

Relative axial movement between the compaction member212and suture cutter device270may be initiated at a location proximal of the skin surface121of the patient at, for example, the handle assembly of the tissue puncture closure device (not shown). In some arrangements, the compaction member212is held stationary while the suture cutter device270is moved axially. In other arrangements, the suture cutter device279is held stationary and the compaction member212is moved axially (i.e., in a distal direction D when compacting the sealing pad210). It may be possible to move the compaction member212and suture cutter device279in opposite directions concurrently to cut the suture.

Referring now toFIGS. 10 and 11, another example suture cutter device370is shown and described. The suture cutter device370may include a lumen372, a distal end opening374, a distal end portion376, and a second aperture378that includes distal and proximal ends380,382, first and second sides384,386, and a cutting surface388. The cutting surface388extends around at least a portion of the second aperture378on at least one of the first and second sides384,386. The cutting surface388may be defined along other portions of the second aperture378such as along, for example, the proximal end382, or along one or both of the first and second sides384,386.

The cutting surface388may be constructed to provide cutting of the suture204, which is extending through the second aperture378and the first aperture254, by rotation of the suture cutter device370relative to the compaction member in the direction R (seeFIG. 10). The relative rotation between the suture cutter device370and the compaction member212may occur by maintaining the compaction member212in a fixed position while rotating the suture cutter device270in one of the directions R, or by maintaining the suture cutter device370in a fixed position while rotating the compaction member212in one of the rotation directions R. It may be possible to provide rotation of both of the compaction member212and suture cutter device370concurrently to cut the suture.

Referring now toFIGS. 12 and 13, another example suture cutter device470is shown and described with reference to another example compaction member412. The compaction member412includes a lumen450, a distal end portion453, a first aperture454having distal and proximal ends460,462, a proximal end portion458, a cutting surface464, and a locking opening466. The first aperture454is defined in the compaction member412at a location spaced between the distal and proximal end portions453,458. The cutting surface464is positioned along the proximal end462at the first aperture454. In other arrangements, the cutting surface464may be positioned along other portions of the first aperture454such as, for example, along the proximal end462or along opposing sides of the first aperture454.

The locking opening466(also referred to herein as a slot or locking slot) is positioned at the proximal end portion458. In the illustrated example, the locking opening466is open along a proximal open end459of the compaction member412. The locking opening466may include multiple sections that provide together relative locking between the compaction member412and the suture cutter device470. In at least one arrangement, the locking opening466is configured to provide a fixed axial orientation between the compaction member412and suture cutter device470when in a locked state, and when in an unlocked state permit relative axial movement between the compaction member412and suture cutter device470.

The suture cutter device470includes a distal end portion476, a second aperture478, a locking tab490, and a first overmold492. The second aperture478includes distal and proximal ends480,482, and a cutting surface488positioned along the distal end480. In other arrangements, the cutting surface488may be positioned along the proximal end482or along portions of opposing sides of the second aperture478.

The locking tab490may extend outward from an outer surface of the suture cutter device470. The locking tab490may be configured to travel through the locking opening466of the compaction member412. In at least one example, the locking tab490is a cylindrical shaped member having a circular cross section. Other shapes and constructions are possible for the locking tab490. In some arrangements, the locking tab490and locking opening466are exchanged with each other so that the suture cutter device470includes a locking opening and the compaction member412includes a locking tab. The locking tab in such an arrangement may extend radially inward from an inner surface of the lumen450of the compaction member412. Many other locking configurations are possible that provide at least some restriction to relative axial or rotational movement between the compaction member412and suture cutter device470when in a locked state, and permit relative axial or relative rotational movement between the compaction member412and suture cutter device470when in an unlocked state.

The first overmold492is positioned at the distal end portion476of the suture cutter device470. The first overmold492may comprise a moldable material such as a polymer-based material (e.g., silicone or similar material). The first overmold492may be interposed between an outer surface of the suture cutter device470and an inner surface along the lumen450of the compaction member412. The first overmold492may provide some frictional contact between the compaction member412and suture cutter device470that limits unintentional axial or rotational movement between the compaction member412and suture cutter device470. The first overmold492may be positioned at any location along the length of the suture cutter device470. In some arrangements, multiple overmolds are positioned at axially spaced apart locations along the length of the suture cutter device470. In other arrangements, the overmold may be divided into separate segments spaced around a circumference of the suture cutter device470. In still further arrangements, the first overmold492may be mounted to an interior surface of the compaction member412within the lumen450.

The arrangement of cutting surfaces464,488provides cutting of a suture that extends through the first and second apertures454,478when the suture cutter device470moves in a proximal direction relative to the compaction member412. Movement of the suture cutter device470in the distal direction relative to the compaction member412may bind the suture between the distal end460and proximal end482of the first and second apertures454,478to retain the suture in a fixed position. Such binding of the suture may also permit creation of tension in the suture during, for example, delivering the sealing pad into a percutaneous incision and compacting the sealing pad.

Referring now toFIG. 14, another example suture cutter device570is shown and described. The suture cutter device570may be configured for use with the compaction member412described above as referenced toFIGS. 12 and 13. The suture cutter device570includes a second aperture578, a locking tab590, a first overmold592, a second overmold594, and a suture retention area596. The first and second overmolds592,594may be spaced apart axially to define the suture retention area596. In some arrangements, the suture retention area596may be defined in one or both of the first and second overmolds592,594The suture retention area596may be configured to provide a space within which a length of suture may be wrapped. In some arrangements, a suture retention area may be provided on a portion of the compaction member412.

The first overmold592has a maximum outer dimension or diameter D1. Typically, the dimension D1is no greater than a minimum internal dimension of the lumen450of the compaction member412. The first overmold592may provide some resistance to unintentional axial or rotational movement between the suture cutter device570and the compaction member412when the suture cutter device570is inserted into the compaction member412(i.e., when the first aperture454is aligned with the second aperture578). In some arrangements, the second overmold594may have a maximum outer dimension or diameter D2. The diameter D2may be greater than diameter D1.

Referring now toFIGS. 15 and 16, another example arrangement of a compaction member612and a suture cutter device670is shown and described. The compaction member612may include a lumen650, a distal end portion653, and a first aperture654having distal and proximal ends660,662. The first aperture654may extend from a distal open end652in a proximal direction to the proximal end662. The first aperture654may have a variable width W that increases in size moving from the proximal end662to the distal end660. In at least one arrangement, portions of the first aperture654may define a cutting surface. The first aperture654may have different constructions in alternative embodiments. For example, the width W of the first aperture654may be relatively constant along its length. In another example, the proximal end662may have a curve or contoured construction rather than the generally linear construction shown inFIGS. 15 and 16.

The suture cutter device670includes a lumen672, a distal end portion676, and a second aperture678. The second aperture678may include a distal end680, a proximal end682, and a cutting surface688. The cutting surface688may extend along opposing sides of the second aperture678at locations between the distal and proximal ends680,682. In other arrangements, the cutting surface688may be defined along at least portions of the distal and proximal ends680,682.

The suture cutter device670may also include a channel feature698that extends along at least a portion of a length of the suture cutter device670. The channel698may be defined by a crescent cross-sectional shape that is formed in the suture cutter device670along at least a portion of its length. In the illustrated example, the crescent cross-sectional shape is defined at the distal end portion676and terminates at the second aperture678. Other constructions are possible for defining the channel698. In at least one example, the channel698is defined using a swaging, stamping or extruding techniques.

The channel698may be sized to retain a suture therein so that the suture may be positioned between an outer surface of the suture cutter device670and an internal surface of the compaction member612along the lumen650. The suture may extend within the channel698from the distal end portion653and then pass through the second aperture678into the lumen672. The sutures may extend proximally from the second aperture678to a location where the proximal end portion of the suture may be handled by another feature of the tissue puncture closure device or by the operator. With the suture extending from the channel698into the second aperture678, movement of the suture cutter device670in the proximal direction relative to the compaction member612will capture the suture between the cutting surfaces688and the proximal end662of the compaction member612, thereby cutting the suture.

Channel features such as the channel698may be defined in other portions of the suture cutter device or within portions of the compaction member. In at least one example, a channel is defined along an exterior surface of the compaction member. In another example, the channel is defined along an interior surface along an internal lumen of the compaction member. It a still further arrangement, the channel is defined in an outer surface of the suture cutter device in an arrangement wherein the channel is not exposed within a first aperture of the compaction member as in the embodiment illustrated inFIGS. 15 and 16. As described above, the channel feature, whether defined in one or both of the compaction member and suture cutter device, may be defined by any desired technique, such as, for example, swaging, extruding, stamping, or heat forming. The channel feature may extend along a portion or an entire length of either one of the compaction member and suture cutter device.

Referring now toFIGS. 17 and 18, another example arrangement of a compaction member712and a suture cutter device770are shown and described. The compaction member712includes a distal end portion753, a first aperture754having distal and proximal ends760,762, and a cutting surface764. The act of forming the first aperture754may define the cutting surface764along the proximal end762. In some arrangements, the cutting surface764is formed in a separate step from forming the remaining portions of first aperture754. The distal end760of the first aperture754may extend to a distal end of the compaction member712to, for example, improve ease of manufacturing or to provide sufficient space for a suture to pass along an exterior surface of the suture cutter device770and into a second aperture778of the suture cutter device.

The suture cutter device770may include a distal end portion776, a second aperture778, and a distal end780. The second aperture778may have any shape, size and construction, including, for example, a cutting surface along at least a portion of the second aperture778. As noted above, the arrangement of the first and second apertures754,778may provide for a pathway for the suture to pass along an exterior surface of the suture cutter device770and through the second aperture778into an internal lumen of the suture cutter device770, or along an internal lumen of the suture cutter device from a distal end of the suture cutter device and out through the second aperture778and first aperture754. In either one of these suture arrangements, proximal movement of the suture cutter device770relative to the compaction member712will capture the suture between the cutting surface764and the distal end780of the second aperture778to provide cutting of the suture.

In other arrangements, an aperture construction similar to first aperture754may be defined in the distal end portion of the suture cutter device770and an aperture of similar construction to the second aperture778may be defined in the compaction member712(i.e., reversal of the first and second apertures754,778). In this arrangement, the cutting surface may be defined along the aperture of the suture cutting device and cutting occurs by the suture cutter device moving in a distal direction relative to the compaction member712. Many other arrangements and constructions for the first and second apertures and the cutting surfaces associated with those apertures are possible.

The first and second apertures754,778may be formed using a variety of techniques such as, for example, laser cutting, machining, or electric discharge machining (EDM). These techniques may be especially useful when the compaction member and suture cutter device comprise a metal material, such as stainless steel. In all of the examples described herein, at least one of the compaction member and suture cutter device may comprise a metal material. In other examples, at least one of the compaction member and suture cutter device may comprise a polymer-based, rubber, ceramic, composite, or other type of material. Forming the apertures and cutting surfaces in the compaction members and suture cutter devices disclosed herein may be conducted using many different techniques, such as those described above relating to the various examples shown inFIGS. 6-18. Further, any of those features described with reference to the examples shown inFIGS. 6-18may be used interchangeably with each other.

The preceding description has been presented only to illustrate and describe exemplary embodiments of the present disclosure. It is not intended to be exhaustive or to limit the invention to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be defined by the following claims.