Suture retention device

Abstract

The suture holding device includes a housing having one or more suture slots. The device also includes a plunger with suture slots. The plunger is slidably positioned within a channel in the housing, and when the housing suture slot is aligned with the plunger suture slot, the suture filament can be positioned within the slot. When the plunger is operated so that the housing suture slot is misaligned with the plunger suture slot, the suture filament is trapped between the plunger and the housing, preventing the movement of the suture filament.

Description

Background Art

[0001] (Claim of Priority) This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 453,020, filed Mar. 17, 2023, the entire contents of which are incorporated herein by reference.

[0002] (Background) Vascular access is generally used for percutaneous diagnostic and therapeutic procedures such as cardiac catheterization or peripheral vascular procedures. Vascular access can be obtained using surgical dissection exposure through tissue to expose the vessel, or more frequently, percutaneous access is obtained using techniques such as the Seldinger technique where a needle is introduced into the vessel and then a guidewire is advanced into the vessel. The guidewire can then serve as a rail over which other devices such as an introducer sheath can be advanced through the tissue into the vessel. The introducer sheath may be used to control hemostasis at the access point and facilitate the introduction of a diagnostic or therapeutic catheter into the vascular system. Upon completion of the diagnostic or therapeutic procedure, the guidewire, sheath, and any other devices are removed from the patient. Pressure is applied to the vascular access site to ensure that bleeding is prevented. In some situations, the access site may not be properly sealed, resulting in unwanted and potentially dangerous blood loss. In some cases, one or more sutures may be applied to the vascular access site to close the puncture site, or a plug such as a collagen plug may be used to help close the puncture site. These devices or closure systems can have issues associated with their use, including additional procedure time, adding cost, and requiring additional training.

Summary of the Invention

Means for Solving the Problems

[0003] Any of the devices disclosed herein may include a therapeutic agent that is delivered on the device and delivered to a patient. For example, a local anesthetic such as lidocaine may be delivered by any of the devices and delivered to a patient to relieve pain. A coagulation agent may be delivered by the device to help ensure that the wound coagulates and bleeding is avoided. The therapeutic agent may be an antibiotic to help prevent infection.

[0004] One of these devices may contain an adhesive backing to help temporarily attach the device to the patient's skin so that it does not fall or become detached from the patient.

[0005] One of these devices may include a foam backing that is placed between the device and the patient to provide cushioning between them.

[0006] Any of these devices may be used to close off any blood vessel in the body, including arteries such as the femoral artery, iliac artery, and radial artery, or the devices may be used to close off any vein in the body, such as the femoral vein. Other non-medical uses are also disclosed herein.

[0007] In drawings that are not necessarily drawn to scale, the same numbering may describe similar components in different drawings. The same numbering with different subscripts may represent different instances of similar components. Generally, the drawings illustrate various embodiments discussed herein as examples, not as limitations. [Brief explanation of the drawing]

[0008] The attached figures include several drawings illustrating embodiments of the suture retention device.

[0009] [Figure 1A] Figure 1A shows a perspective view of an embodiment of the suture holding device.

[0010] [Figure 1B] Figure 1B shows an exploded top view of the device in Figure 1A.

[0011] [Figure 1C] Figure 1C shows a top view of the device in Figure 1A.

[0012] [Figure 1D] Figures 1D-1E show top views of an example of the operation of the plunger release tab. [Figure 1E] Figures 1D-1E show top views of an example of the operation of the plunger release tab.

[0013] [Figure 2A] Figure 2A shows a perspective view of the housing in Figure 1A.

[0014] [Figure 2B] Figure 2B shows an end view of the housing in Figure 2A.

[0015] [Figure 2C] Figure 2C shows an end view of the end of the housing in Figure 2A opposite to Figure 2B.

[0016] [Figure 3] Figure 3 shows a perspective view of an example of a plunger that highlights the upper surface.

[0017] [Figure 4] Figure 4 shows a perspective view of the bottom surface of the plunger in Figure 3.

[0018] [Figure 5] Figures 5A-5B show perspective views of an example of a cutter element.

[0019] [Figure 6A] Figures 6A-6C show perspective views of an example of the operation of the release tab. [Figure 6B] Figures 6A-6C show perspective views of an example of the operation of the release tab. [Figure 6C] Figures 6A - 6C show perspective views of an embodiment of the operation of the release tab.

[0020] [Figure 6D] Figures 6D - 6F show perspective views of another embodiment of the operation of the release tab. [Figure 6E] Figures 6D - 6F show perspective views of another embodiment of the operation of the release tab. [Figure 6F] Figures 6D - 6F show perspective views of another embodiment of the operation of the release tab.

[0021] [Figure 7] Figure 7 shows a perspective view of an embodiment of the stop element.

[0022] <​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Figures 9A-9M show an example of a method for closing a wound using a suture retention device. [Figure 9J] Figures 9A-9M show an example of a method for closing a wound using a suture retention device. [Figure 9K] Figures 9A-9M show an example of a method for closing a wound using a suture retention device. [Figure 9L] Figures 9A-9M show an example of a method for closing a wound using a suture retention device. [Figure 9M] Figures 9A-9M show an example of a method for closing a wound using a suture retention device.

[0024] [Figure 10A] Figure 10A shows an example of a vascular access site.

[0025] [Figure 10B] Figure 10B shows an example of the figure-eight stitch pattern.

[0026] [Figure 10C] Figure 10C shows an example of an infinite stitch pattern.

[0027] [Figure 10D] Figure 10D shows examples of both suture patterns from Figures 10B-10C used to close a wound.

[0028] [Figure 11] Figure 11 shows a perspective view of another embodiment of the plunger.

[0029] [Figure 12] Figure 12 shows a perspective view of another embodiment of the suture holding device. [Modes for carrying out the invention]

[0030] (Detailed explanation) Vascular occlusion devices (VCDs) are medical devices used to achieve hemostasis of small holes in arteries or veins after cardiovascular or endovascular procedures requiring catheter placement. VCDs may be used on arteries or veins, and this is not intended to be limited.

[0031] Cardiovascular procedures requiring catheter placement include diagnostic procedures that help diagnose affected blood vessels or other tissues, and interventional procedures such as angioplasty, stent placement, and coronary thrombectomy that treat and repair affected or damaged tissues. Other diagnostic and therapeutic procedures are also considered.

[0032] During such procedures, a small incision is made within the inguinal area, and a hole is created in the femoral artery to obtain access to the artery. This hole is referred to as the access site or puncture site. Upon completion of the procedure, the hole needs to be closed. A VCD can be used to help achieve hemostasis, instead of manual compression. The VCD may include a collagen plug, a suture alone, or a suture in combination with a suture holding device, or other devices used to help close the wound. The suture may be applied to the tissue adjacent to the wound, and then the suture may be tied and tension maintained within the suture, which helps close the wound, or a suture holding device may be used to help hold the suture in the desired position with the desired tension. In other procedures, access is obtained from a vein, such as the femoral vein, in transseptal procedures, where a catheter is advanced from the right side of the heart across the septum into the left side of the heart. In both situations, namely venous or arterial access, the puncture site must be closed to prevent unwanted bleeding. Vascular closure devices may be used to facilitate the closure of the puncture site. While this disclosure will focus on suture retention devices, this is not intended to limit it, and those skilled in the art will understand that the embodiments disclosed herein may be used to hold or retain other filaments for medical or non-medical purposes. Thus, this disclosure is not limited to wound closure.

[0033] Examples of suture retention devices are disclosed herein. These examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0034] (Example of a suture retention device) Sutures may be used to help close the puncture site, and suture retention devices may be used to help maintain tension on the suture so that the vascular access remains closed until hemostasis is achieved. Since many of these patients may be able to go home on the day of the procedure, it may be desirable that the device have features to facilitate the patient cutting the suture and removing the device at home without having to return to the hospital or clinic. These embodiments are described as venous closure devices, suture retention devices, or vascular closure devices, but those skilled in the art will understand that their use is not limited to veins only, and that they may be used on arteries or other blood vessels and tissues. Any of the devices disclosed herein may be applied by a medical practitioner, removed by a medical practitioner, or removed by the patient at home. Other uses, including non-medical uses, are also discussed and disclosed herein.

[0035] Maintaining tension on the suture requires that the suture be captured either by friction or, if a knotless system is desired, through a secure locking engagement. Alternatively, a knot may be formed within the suture, if desired.

[0036] In one embodiment, interfacial contact between the suture and the body of the suture-holding device is made via a plunger and a housing that receives the plunger. The portion of the plunger that interacts with the suture can have a variable geometric shape (rectangular, tapered, serrated, etc.). The material of the interface between the plunger, the suture, and the body of the suture-holding device can be made from a material of variable hardness. A rigid material will accommodate sutures of variable diameter, depending on the yielding properties of the suture material and the flexibility of the suture-holding device. A flexible material will accommodate sutures of variable thickness, depending on the yielding properties of the material itself. The suture-holding force needs to be optimized to maximize the amount of force required for the suture to slide while minimizing vascular or tissue damage.

[0037] The cross-section of the plunger may be rectangular, circular, or any other shape to best fit the overall size of the suture retention device. While rectangular and cylindrical plungers are illustrated in the images disclosed herein, this is not intended to be limiting. The figures illustrate the optional use of “O-rings” of different durometer materials to optimize suture retention force.

[0038] In another embodiment, the "plunger" is spring-loaded and, in response to pressing the plunger downward into the housing, opens the channel and inserts the suture. In response to releasing the plunger, the plunger is reverse-pushed by the spring force, the channel space is reduced, and a holding force is generated on the suture.

[0039] In another embodiment, the suture thread is passed through the gap between the inner and outer components of the suture-holding device. Then, either the inner or outer body of the suture-holding device is twisted, which generates a secure locking force on the suture thread.

[0040] The plunger may have a locking feature to provide additional suture retention force and prevent the plunger from being pushed outward. This feature would also have a release option to allow the healthcare provider to release the plunger when required.

[0041] The cutting mechanism on the suture holding device can utilize any number of embodiments, and the cutter can be manually operated or spring-operated. In the manually operated version, the cutter holder is pressed by the patient or healthcare provider, which causes the blade attached to the holder to push through the suture and cut as close to the skin as possible. In the spring-loaded version, the removal of a brake or retaining pin will release the cutter holder from the spring under tension, causing it to pull / push towards the suture and perform the cut.

[0042] The interface between the suture retention device and the skin can be a soft foam or silicone substrate layer. The foam may be coated with a material doped with an antimicrobial agent, an antimicrobial analgesic, and / or coagulant to minimize the chance of infection and help with pain relief, etc.

[0043] The foam can also be coated with the above-mentioned combination of therapeutic agents to achieve enhanced effects.

[0044] In another embodiment, the cutter safety stop element is attached to an adhesive tape with a handle at one end, such that when the tape is peeled off, the cutter safety stop element is removed along with the tape.

[0045] Now, let us look at Figures 1A-1E, which show an embodiment of the suture retention device 102. The suture retention device may be supplied alone or in combination with other components such as one or more suture filaments. Figure 1A shows a perspective view of the device in the closed position, and Figure 1B shows an exploded view of the device from above. Figure 1C shows a top view of the device in the open position. Figures 1D-1E show a top view of the operation of the release tab for retracting the plunger from the closed configuration to the open configuration.

[0046] In Figure 1A, the suture holding device 100 includes a housing 102, a release tab 104, a plunger 106, one or more housing suture slots 108 (in this case, there are two housing suture slots), a cutter release tab 110, a stop element 112, and a cutter element 114. The plunger also has one or more plunger suture slots, which are best seen in Figure 1B. The number of suture slots in the plunger may match the number of suture slots in the housing.

[0047] The housing 102 may be clear so that the operator can see inside the housing and visualize the location of the plunger 106 inside the housing or the sutures (not shown in Figure 1) placed in the slot 108. To help visualize the plunger through the clear housing, the plunger may be colored off-white or any other desired color. The plunger also has plunger suture slots, which are invisible in the diagram in Figure 1A-1E and will be illustrated below. The housing 106 includes a channel for slidably receiving the plunger 106 and also includes a channel for slidably receiving the cutter element 114. The stop element 112 is releasably coupled to the housing 102 once the release tab 110 is released from the housing. The release tab 110 may be an adhesive tape which is coupled to the housing 102 and the stop element 112, or a pin in a recess may be used as discussed below.

[0048] Another release tab 104 may be used to help remove the plunger from the housing, either completely or partially. The release tab 104 may be pivoted upward away from the upper surface of the plunger and then rotated along a central axis, which may be perpendicular or lateral to the plane of the upper surface of the plunger. This action helps to retract the plunger out of the housing and realign the suture slot in the plunger with the suture slot in the housing, allowing the suture to be repositioned into the housing suture slot 108, when desired. A pin 130 may be used to couple the release tab 104 to the plunger. The pin may be T-shaped and allow rotation along two axes, as will be discussed and illustrated below.

[0049] Figure 1B shows the upper surface of the suture holding device in an exploded view, allowing observation of additional features of the device that are not normally visible in Figure 1A. For example, the housing 102 may include a projection 216, which is received in a recessed area at the bottom of the plunger, preventing the plunger from coming out of the housing and becoming disengaged. The opposite end of the housing also includes a recessed area 208, which may be used to receive a projection 120 on the bottom of the cutter element 114, preventing the cutter element from coming out of the housing and becoming disengaged. The cutter element 114 includes a blade with a sharp cutting edge 122 capable of cutting suture filaments. The cutting edge may be angled so that when the blade is pressed against the suture filament, the blade provides a shearing cutting action to the suture filament, cutting the filament more cleanly and easily than if the cutting blade were pressed straight into the filament. These features are described in more detail below. The plunger 106 also has an elongated slender body and an enlarged head region, as further described in Figure 3 below, and is molded to form a T-shaped plunger. The plunger optionally includes surface features or textures 308, which may help generate a greater interference fit between the plunger and the inner surface of the housing when the device is in the closed position. Here, the surface features include rows of raised surfaces, forming peaks and valleys. The plunger also has one or more plunger suture slots 306, which cooperate with housing suture slots to receive suture filaments when the device is in the open position and hold suture filaments when the device is in the closed position. These features will be described in more detail later in this specification. Other aspects of Figure 1B are identical to those of Figures 1A and 1C.

[0050] Figure 1C shows the device of Figures 1A-1B in an open configuration. Here, the housing suture slot 108 is aligned with the plunger suture slot 308, providing a path that opens from the bottom of the housing through the plunger to the top of the housing, allowing suture filaments to be received. Thus, in the open configuration, the J-shaped slots are aligned. Also shown is a crushed configuration in which the release tab 104 lies flat against the plunger when not in use. The release tab 104 may, if required, be grasped by the operator with the thumb and index finger, etc., and then rotated clockwise or counterclockwise to rotate vertically upward so that the plunger can be retracted out of the housing. Other aspects of Figure 1C are identical to Figures 1A-1B.

[0051] Figures 1D-1E illustrate the operation of the release tab 104. In Figures 1A-1C, the release tab 104 is in a closed configuration, and the release tab is positioned flat relative to the plunger. The release tab is therefore positioned on a plane that is flat and parallel to the upper surface of the plunger 106. When an operator desires to remove the plunger from the housing, the operator may grasp the enlarged head portion of the plunger and pull the plunger out of the housing. However, in some situations, the enlarged head may not provide sufficient grip to pull the plunger. Therefore, a release tab may be used to facilitate the release of the plunger from the housing. To use the release tab, the user will rotate or invert the release tab upward from its horizontal position so that it is in a vertical position. Here, the release tab is now positioned on a plane that is lateral to or perpendicular to the upper surface of the plunger, and the release tab may protrude outward and away from the upper surface of the plunger, as seen in Figure 1D. This provides a proper grip for the user to grasp. The release tab pivots upward around the T-shaped pin 130, which is inserted into an opening 310 in the plunger, allowing it to rotate or pivot along the horizontal or upper bar portion of the T-shaped pin, and also allowing it to rotate along the long axis or vertical portion of the T-shaped pin. Further details about the T-shaped pin are described below. Once the pin is in the vertical position, the user may then rotate the release tab about the vertical axis of the vertical portion of the T-shaped pin. Rotation along the vertical axis presses one end of the release tab against the housing, while the opposite end of the release tab moves away from the housing. This moves the plunger outward and away from the housing. The projection 312 prevents over-rotation of the release tab, so that when the release tab contacts the projection 312, further rotation is prevented. Three projections are shown here, but any number of projections, such as one, two, three, or more, may be used as stoppers. Figure 1E shows the rotation of the tab to release the plunger from the housing.

[0052] Figure 2A shows the housing 102 with all components removed, i.e., the plunger 106, stop element 112, and cutter element 114, etc. The release tabs 104 and 110 are also removed. Therefore, only the housing 102 is seen in Figure 2A. Here, a flat planar surface 212 extends from one end of the housing, and a channel 206 is located inside the housing and extends along the longitudinal axis toward the opposite end of the housing. In this figure, the channel is shown on the upper right side of the housing, but is invisible on the upper left side of the housing. The channel may extend all the way from left to right, or the channel may extend from left to right of the housing, but the channel does not have to be a through channel that extends all the way to the right side of the housing. The flat planar surface 212 provides a surface for supporting the plunger when the plunger is inserted into the channel 206. In addition, the flat planar surface 212 may include a projection 216, which is received in a cooperating recess within the bottom of the plunger. The protrusion prevents the plunger from coming out of the channel 206 once the plunger is inserted into the channel. In other embodiments, the protrusion and recess may be switched relative to each other, with the protrusion on the plunger and the recess inside the housing. Alternatively, one side of the protrusion may have an angled surface to facilitate the insertion of the plunger into the channel, while the opposite side of the protrusion may be a straight, vertical portion to prevent the protrusion from easily coming out of the recess.

[0053] The housing may be clear so that the user can visualize the position of the plunger inside the housing, and a clear housing allows the user to see the suture filaments when they are placed in the slots 108. Here, the housing has two housing suture slots 108. Each slot may be lateral to the longitudinal axis of the housing and perpendicular to the longitudinal axis of the housing. The slot may have a long linear portion and a curved and enlarged head region that form a J-shaped slot for receiving the suture filaments. The enlarged head region helps to hold the suture filaments and also helps to keep the suture filaments from coming out of the slot.

[0054] The opposite end of the housing 102 (the right side in Figure 2A) shows a channel 206 for the plunger to extend through the housing wall. However, as described above, the channel 206 does not need to extend through the housing wall, and the channel may be a blind channel.

[0055] The cutter channel 210 may be located within the housing, and may extend along the longitudinal axis of the housing. The cutter channel may open on the upper right side of the housing and extend all the way through the upper left wall of the housing to the housing, or it may be a blind channel that does not extend through the upper left wall of the housing. The cutter channel 210 is located below the plunger channel 206. The bottom surface 204 of the housing 102 may include a recessed area 208 that can receive a projection on the bottom of the cutter element (not shown in this figure). When the projection is received within the recessed area, this prevents the cutter from coming out of the cutter slot and becoming disconnected from the housing. In other embodiments, the projection on the cutter element and the recess in the housing may be reversed so that the projection is on the housing and the recess is on the cutter element.

[0056] The right side of the housing also includes a pair of walls 202, with a higher region and a lower region forming a shoulder region that can support a stop element (not shown in this figure). The stop element prevents the cutter element from moving through the cutter channel and thus prevents accidental cutting of suture filaments. The stop element is easily removed from the shoulder region, which then allows the cutter element to advance into the cutter channel and cut one or more of the suture filaments. A stop release tab 110 (shown in Figure 1) may be used to help keep the stop element in place, and when the stop release tab is removed, the stop element can be activated or easily removed as well.

[0057] Protrusions such as pins 220 may extend upward and outward from the upper surface of the housing 102. The pins may be received by openings 710 within the cutter release tab 110 (best seen in Figure 7). This helps prevent undesirable movement of the cutter release tab and thus helps keep the stop element 702 in place, preventing undesirable movement of the cutter blade. In other embodiments, the positions of the protrusions and openings may be interchangeable. In other embodiments, the cutter release tab may also have adhesive on its bottom surface, which adheres to the housing and helps prevent movement. The adhesive may be used alone or in conjunction with the protrusion and opening features.

[0058] The recessed area 222 on the upper surface of the housing 102 allows the user to insert a finger or other object under the cutter release tab, lift the tab, and disengage it from the protrusion, thereby allowing the user to remove the stop element so that the cutter can be operated to cut suture filaments.

[0059] The bottom surface 214 of the housing may be flat and planar so that it can be placed on the same plane as the patient's body during use. In addition, a substrate may be applied to the bottom surface. The substrate may be a foam material to prevent excessive pressure from being applied to the patient, or the substrate may carry therapeutic agents such as lidocaine or other pain relievers that leach from there, or antibiotics that help prevent infection. Other therapeutic agents may also be used.

[0060] Figure 2B shows an end view of the housing in Figure 2A. This figure illustrates the right end of the device in Figure 2A, which is the end with the cutter element. Figure 2B highlights the plunger channel 206, which may extend all the way through to the housing as described above, or it may be a blind channel that opens only on the left side of the housing and does not pass through the housing wall on the upper right side of the housing. The cutter channel 210 is also visible in this figure, and it is a channel that opens on the right side of the housing and extends through the housing at least to the housing suture slot so that the blade can be pushed sufficiently inward to cut the suture filament. The cutter channel may extend all the way through to the left side of the housing, or it may be a blind channel that extends only partially through the housing and does not exit from the left side of the housing. The other sides of the housing are the same as those described above in Figure 2A.

[0061] Figure 2C is also an end view of the housing in Figure 2A. This figure shows the left end of the device in Figure 2A, which is the end with the plunger. Figure 2C highlights the plunger channel 206, which recedes from the housing at this end to accommodate the plunger. The other sides of the housing are identical to those described above in Figures 2A and 2B.

[0062] Figure 3 shows the plunger 106 removed from the housing. Here, the plunger includes an elongated narrow region 302 and a wider, enlarged head region 304, forming a substantially T-shaped plunger. The narrow region 302 is received within the plunger channel in the housing, and the enlarged head region is used to push the plunger into the channel and to remove the plunger from the channel.

[0063] The plunger also includes plunger suture slots 306. Here, two such slots are present, but more or fewer slots may be present as required. The plunger suture slots include an elongation linear portion which is transverse to the longitudinal axis of the plunger and may be orthogonal. The plunger slots also include an expanding head region which is coupled to the elongation slots to form a J-shaped slot. The expanding head helps to hold the suture filament so that it is retained within the plunger slot and does not come loose. When the plunger is inserted into the channel in the housing, the plunger has an open position and a closed position. In the open position, the plunger suture slots 306 align and cooperate with the housing suture slots so that the suture filament can be easily inserted into or removed from the slot. In this configuration, the plunger is partially, but not fully, located within the channel in the housing. In the closed configuration, the plunger suture slots are axially offset from each other and therefore misaligned with the housing suture slots, which creates an interlocking fit between the plunger surface, the inner wall of the housing, and the suture filament, thereby preventing movement of the suture filament. In this configuration, the plunger is further advanced into the channel within the housing so that the slots are misaligned with each other.

[0064] Optionally, textured surfaces of the plunger (on the top surface, or on the bottom surface, or on both the top and bottom surfaces) may further improve and create a tight fit between the plunger, the housing, and the suture filament, helping to hold the suture filament and prevent movement. Here, the surface texture is shown as multiple ribs protruding outward from the surface of the plunger and extending laterally or perpendicularly to the longitudinal axis of the plunger.

[0065] The plunger 106 also includes an opening 310 for receiving a pin, which is coupled to a release tab 104 (shown in Figure 1). The pin allows the release tab to rotate around one, two, or more axes of the pin, depending on the pin used, which in this embodiment may be perpendicular to the flat planar surface of the plunger on the upper surface of the plunger. One or more projections 312 (in this embodiment, three projections) may also be included on the enlarged head portion of the plunger, and these projections may be used to limit rotation or prevent over-rotation of the release tab when pivoting around the axis of the opening 310.

[0066] Figure 4 shows a bottom view of the plunger 106. The bottom of the plunger may include a recessed area 316 which receives a projection 216 on the housing. Once the projection is received in the recess, this prevents the plunger from coming out of the channel in the housing and the two components from becoming disconnected from each other. As described above, the projection and the recess may be interchangeable such that the projection is on the plunger and the recess is on the housing. In this figure, the recess 316 may also have an angled or slanted portion which helps the projection on the housing slide into the recess but prevents the projection from moving out of the recess. The lower end of the slant may be in close proximity to the narrow portion of the plunger, and the higher end of the slant may be in close proximity to the enlarged head region of the plunger. Other sides of the bottom surface of the plunger are generally identical to the top surface; therefore, similar numbers indicate similar features with respect to the top and bottom surfaces, and detailed descriptions will not be repeated for the sake of brevity.

[0067] Figures 5A-5B show the upper and lower sides of the cutter element 114. The cutter element 114 is an L-shaped section comprising a vertical wall 504 and a horizontal wall 502, which together form an L-shaped component. The lower wall 502 is a flat planar section that slides in and out of the channel within the housing. The leading edge of the lower wall 502 is the portion of the lower wall that first enters the cutter channel within the housing and includes a blade 122 with a sharp cutting edge capable of cutting through suture filaments. The cutting edge may be straight and parallel to the leading edge of the lower wall, or, as seen in Figure 5A, the cutting edge may be angled with respect to the leading edge of the cutter element, providing a shear cutting action as the cutting element advances into the cutter channel and is pushed against the suture filaments. The vertical wall 504 is lateral to the lower wall and can be in a horizontal plane, while the vertical wall is placed in a vertical plane and can be lateral or perpendicular to the lower wall. The top of the vertical wall may be rounded and have sharp edges removed that could damage or cut a surgeon's gloves during use.

[0068] Figure 5B shows the lower surface of the cutter element 114, more clearly the cutting element 122, and also illustrates a projection on the cutter element, which is received in a recess within the housing and prevents the cutter element from coming out of the cutter channel within the housing. Other aspects of Figure 5B are generally identical to those in Figure 5A.

[0069] Figures 6A-6C show the release tab 104 and the pin 130 that connects the release tab to the plunger. The pin 130 is a T-shaped pin with a horizontal portion 602 and a vertical portion 604 that allow the tab to rotate in two directions.

[0070] Figure 6A shows a rectangular release tab 104, but this may also be any other desired shape, with a flat surface and optional textured surface 608, which may facilitate the operator's grip of the release tab. In this configuration, the release tab will be flat and horizontal when not in use, and will be flat with respect to the surface of the plunger. The horizontal portion 602 of the pin 130 has a pin with an enlarged end, and both ends of the pin are coupled to wings 610 on both sides of the release tab, thereby allowing rotation of the horizontal portion of the pin about a longitudinal axis. The coupling may be by snap fitting or by other techniques known in the art. The vertical portion of the pin 604 is coupled to the horizontal portion of the pin, allowing rotation of the vertical portion of the pin about a longitudinal axis. Thus, the pin can move along two axes. The two axes may be lateral to each other and orthogonal to each other. A return 606 on the vertical portion of the pin may be used to help ensure a tight interlocking fit with the receiving opening 310, as seen in the plunger example.

[0071] In Figure 6B, the release tab is rotated upward and away from its flat position, where it stands vertically upward. It may be rotated to any angle from 0 degrees (the tab is flat) to 90 degrees (the tab is vertical and perpendicular to the plunger). The release tab may be rotated further than 90 degrees so that the tab begins to lie flat again on the side of the plunger opposite to its original tab position. Thus, the tab may be rotated to any position from more than 90 degrees to a maximum of 180 degrees (where the tab is flat again). When the tab is rotated upward from the flat position (0 or 180 degrees), it provides a surface that can be easily grasped and then rotated by the user.

[0072] Figure 6C shows the rotation of the vertical portion of the T-shaped pin around its longitudinal axis. In this situation, one end of the release tab approaches the housing wall, while the opposite end of the release tab moves toward a projection within the plunger so as to move away from the plunger wall (best seen in Figure 1E). When the end of the release tab is pressed against the housing wall, the plunger is pushed outward and away from the housing, moving the plunger out of the channel within the housing. The position of the plunger may be adjusted as desired, such as to a position where the suture slot on the plunger aligns with the suture slot on the housing, releasing the suture and allowing the suture to move. Excessive rotation of the release tab is prevented by the projection 312 on the plunger.

[0073] Once the release tab and plunger have completed their operation, the release tab may be realigned and set back to a flat configuration so that it lies flat relative to the plunger.

[0074] Figures 6D-6F show the operation of another embodiment of the release tab 104a for retracting the plunger from the housing. The release tab 104a includes a pin 130a, similar to the pin 130 described above. In this embodiment, the pin 130a is a cylindrical pin having a vertically oriented portion 604a and a barbed end 606a that allows rotation about the longitudinal axis of the pin 130a when coupled with the plunger. The pin 130a does not have the horizontal portion seen in the previous embodiment. The pin 130a couples the release tab 104a to the plunger. The release tab 104a includes an integrated hinge 611, which is positioned between the release tab 104a and the pin 130a. The integrated hinge 611 allows the release tab 104a to pivot from a flattened closed position to an open, vertically oriented position that can be easily grasped by an operator. In the closed position, the release tab is generally in a flat planar configuration, approximately parallel to the upper surface of the plunger, and is positioned approximately flat with respect to the plunger. In the open position, the tab can be rotated or pivoted upward and away from the flat position to a vertical position, which may be lateral or perpendicular to the flat position. Thus, the tab may be rotated to any position between 0 degrees and a maximum of 90 degrees, where 0 degrees represents a release tab positioned flat with respect to the upper surface of the plunger, and 90 degrees represents a release tab extending perpendicular and perpendicular to the upper surface of the plunger. In addition, the release tab may also be rotated further beyond the 90-degree vertical position to move away from its original flattened position and towards the flattened position, and thus the tab may be rotated to any position between 90 degrees and 180 degrees, as desired, where 180 degrees represents a release tab positioned flat with respect to the upper surface of the plunger.

[0075] Figure 6D shows a rectangular release tab 104a, but this may also be any other desired shape, with a flat surface and optional textured surface 608a, which may facilitate the operator's gripping of the release tab 104a. In this configuration, the release tab will be laid flat and horizontal when not in use, and will be laid flat relative to the surface of the plunger. Here, the integrated hinge 611 is in the closed position. The integrated hinge may be a thin, elastic material piece, such as a polymer, which connects the release tab to another part 602a of the release tab, which is coupled to a pin 130a. The thin, elastic material can bend multiple times from the open position to the closed position and vice versa without fracture caused by fatigue, thereby forming the integrated hinge 611. The vertical portion 604a of the pin 130a is coupled to the bottom portion 602a of the release tab 104a, and the integrated hinge 611 allows the release tab to rotate or pivot along the longitudinal axis of the integrated hinge. Therefore, the rotation of the release tab occurs along two axes, the first being a rotation around the longitudinal axis of the integrated hinge, and the second being a rotation around the longitudinal axis of the pin. The two axes are transverse to each other and may be orthogonal to each other. A return 606a on the vertical portion of the pin may be used to help ensure a tight interlock with the receiving opening, as seen in the plunger examples described herein.

[0076] In Figure 6E, the release tab 104a is lifted and rotated from the closed position in Figure 6D to the open position. Here, the integrated hinge 611 is seen in the open position. The release tab is rotated along the longitudinal axis of the integrated hinge, as seen by the arrow, so as to be upward and away from its flat position, where it is erected vertically upward. It may be rotated to any angle from 0 degrees (the release tab is flat) to 90 degrees (the release tab is vertical and perpendicular to the plunger). The release tab may be rotated further than 90 degrees so that the tab begins to lie flat again on the side of the plunger opposite to its original tab position. Thus, the tab may be rotated to any position from more than 90 degrees to a maximum of 180 degrees (where the tab is flat again). When the tab is rotated upward from the flat position (0 or 180 degrees), it provides a surface that can be easily grasped by the user and then rotated about the longitudinal axis of the pin.

[0077] Figure 6F shows the rotation of the release tab 104a about the vertical axis of the vertical portion 604a of pin 130a, as indicated by the circular arrow. Here, the release tab 104a is coupled to the plunger 106a using pin 130a. In this situation, as the release tab 104a is rotated counterclockwise, one end of the release tab 104a approaches the wall of the housing 102, while the opposite end of the release tab moves away from the housing wall towards a projection in the plunger (not shown in this figure, but for example, seen in Figure 1E). Rotation in the opposing direction (clockwise) results in opposing motion of the release tab. When the end of the release tab is pressed against the housing wall, the plunger 106a is pushed outward and away from the housing, retracting the plunger away from the housing channel and away from the housing 102. The plunger's position may be adjusted, as desired, to a position where the suture slot on the plunger aligns with the suture slot on the housing, releasing the suture and allowing it to move. Excessive rotation of the release tab is prevented by a projection 312 on the plunger (not shown in Figure 6F, but illustrated in Figure 1E). Other aspects of the housing 102 and plunger 106a are generally the same as those described above with respect to the housing 102 and plunger 106a as described herein.

[0078] Once the release tab and plunger have been operated, the release tab may be realigned and set back to a flat configuration so that it lies flat against the plunger. The plunger may then be pressed and advanced to return to the housing channel, if desired, to close the device and lock the suture filament. The operation of the release tab to retract the plunger from the housing may be repeated as needed.

[0079] Figure 7 shows a stop element 112 and a release tab 110 coupled to the stop element 112. The stop element provides a stopper as described above, preventing the cutter element from being activated and inadvertently cutting suture filaments. When the stop element 112 is removed, the cutter element may be activated. The stop element has a rectangular body 702 with wings 704 extending outward from either of the upper corners. The wings 704 are wide enough to sit on shoulder portions 202 on the housing (see Figure 2A). The release tab 110 includes an extension arm 708 coupled to the stop element and with an enlarged head area 706 that provides a larger area for the operator to grip. When in use, the operator can hold the enlarged head area and lift it upward, thereby also lifting the stop element away from the housing, thereby removing the stop element and allowing the cutter element to be activated. The release tab may have adhesive on its bottom surface to adhere to the housing and help prevent unwanted movement. In this embodiment, the release tab 706 includes an opening 710 which receives a protrusion such as a pin (e.g., protrusion 220 in Figure 2A) and helps to keep the release tab and stop element in place until the user desires to operate the cutter blade. The adhesive may be used alone or in combination with the opening and protrusion embodiment, or the opening and protrusion may be used without adhesive. In other embodiments, the opening and protrusion positions may be interchanged such that the opening is on the housing and the protrusion is on the release tab. Other shapes may also be used for the stop element and release tab, and these are not intended to be limiting.

[0080] Figure 8 shows an optional substrate 802 that may be installed on the bottom surface of the housing. The substrate may be rectangular in shape and have the same area occupied as that of the bottom of the housing. The substrate may include cutouts 804 to prevent the substrate from interfering with the housing suture slots. The upper surface of the substrate may be adhesively bonded to the bottom surface of the housing, or the substrate may be attached using other techniques known in the art. The substrate may be a soft, resilient foam that provides cushioning and prevents trauma when the device is placed against the patient's skin and tension is applied to the suture filaments. The substrate may also have an adhesive layer on its bottom surface to help adhere the device to the patient's skin. In this embodiment, there may also be a backing layer 808 covering the adhesive, which can be removed by peeling it off the adhesive immediately before the device is applied to the patient's skin. In any embodiment, the substrate 802 may also carry a therapeutic agent 806 that can be eluted from the substrate into the patient. For example, analgesics such as lidocaine may be transported by the substrate and delivered to the patient to reduce local pain. Alternatively, antibiotics may be eluted from the substrate layer to prevent infection around the wound site. Or, a combination of therapeutic agents may be used.

[0081] Figures 9A–9M illustrate examples of methods of use for any of the devices illustrated herein. The examples primarily focus on using the devices disclosed herein to secure tension within a suture and to close a vascular access site into a blood vessel, such as a vein or artery. This is not intended to be limiting, and those skilled in the art will understand that the devices disclosed herein may be used in other applications. In addition, as described above, the devices may be provided alone or with one or more sutures. Several other examples will be disclosed below.

[0082] In Figure 9A, a suture retention device 902, which may be any of the devices disclosed herein, is used to help close a vascular access site 904 in a patient after a catheterization procedure or other medical procedure that accesses the vascular system. The device may be supplied in an open or closed configuration, but it should be noted that Figure 9A shows the device in an open configuration, where the plunger is pulled out of the housing so that the housing suture slot aligns with the plunger suture slot. This will be illustrated more clearly below. The vascular access site 904 may include a catheter or a sheath or other vascular device 906 or both, which is introduced percutaneously or by cutting into a blood vessel 910, such as a vein or artery, through the patient's skin 908. A suture 912 may be applied to the vascular access site after the procedure is completed to help facilitate wound closure. For example, the suture 812 may be applied using a figure-eight pattern, where the first loop is positioned on one side of the device 906, through the tissue, under the device 906, and exits the tissue on the opposite side of the device. The suture filament is then crossed at an angle to the first side of the device, either upstream or downstream of the first loop, across the tissue surface, and then inserted through the tissue to the opposite side of the device, returning into the tissue. The suture filament exits the tissue, leaving the second loop inside the tissue, with two free ends exposed to the outside of the tissue. The second loop may or may not be positioned under the device. Generally, both loops may also not loop subvascularly. The two free ends 912 are then bound together, forming an "X" shaped pattern on the upper surface of the skin, and may also form a figure-eight. This suture pattern is commonly used to close vascular access sites. However, in this embodiment, the free ends are not tied together, and a suture holding device will be used to secure the free ends. Therefore, this embodiment of the method is a knotless method or a knot-free method.When the filament is stretched and its free end is bound or otherwise secured, the resulting compressive force within the skin is appropriate for closing and sealing the wound within the skin and preventing blood leakage, applying compressive force to the access point in the blood vessel. Sutures are generally used when a wound site does not close using conventional pressure application, or to ensure that the wound remains closed even after pressure has been applied.

[0083] In Figure 9B, the figure-eight suture is sutured inside the patient, and the catheter, sheath, or other device has been removed. Both free ends 912 are not sutured and remain free ends. The suture retaining device 900 is advanced toward the free ends 912. The suture retaining device is in the open position, and the plunger is retracted from the housing so that the plunger suture slot is far enough away to align with the housing suture slot. Optionally, a base material layer may be included with the suture retaining device 900, and the backing layer 914 may be peeled away from the base material at this point or at a later stage of the process if desired.

[0084] In Figure 9C, one of the free ends 912 is positioned through the first plunger suture slot and the first housing suture slot (aligned with each other), and is advanced into the enlarged head region of the suture slot to help hold it in place.

[0085] Figure 9D shows a second free end 912 that is positioned through a second plunger suture slot and a second housing suture slot (aligned with each other), and then advances into the enlarged head region of the suture slot to help hold it in place.

[0086] Figure 9E shows a cross-section of Figure 9D obtained along the longitudinal axis of the device. The suture filaments 912 pass easily through both the housing suture slot 108 and the plunger suture slot 306 because they are aligned with each other. Other aspects of the suture holding device are identical to those described above.

[0087] Figure 9F shows that once both filaments are positioned within their respective suture slots, the suture retaining device 900 can then be slidably advanced toward the wound site 904 across both free ends until the suture retaining device contacts the patient's skin.

[0088] In Figure 9G, tension is applied to both free ends 912 of the suture filament, ensuring that the suture retaining device 900 is firmly in contact with the patient's skin, and that the figure-eight suture closes the wound, applies appropriate compressive force to the tissue, and closes the intravascular puncture site. Once the operator is satisfied with the tension in the suture filament, the operator may close the suture retaining device by pushing the plunger into the plunger channel in the housing so that the plunger suture slot is misaligned with the housing suture slot, thereby creating an interlocking fit between the suture filament, the plunger, and the housing that captures the suture filament, prevents movement, and maintains tension in the suture.

[0089] Figure 9H shows a cross-section of Figure 9G obtained along the longitudinal axis of the device. Once the plunger 106 is pushed into the housing 102 so that the device is in a closed configuration, the suture is trapped between the housing and the plunger surface, forming an interlocking fit, which prevents the movement of the suture filament 912. The interlocking fit is generated because the housing suture slot 108 is no longer aligned with the plunger suture slot 306.

[0090] Figure 9I shows the release of the plunger 106 from the housing 102. In some situations, the operator may want to return the device from a closed configuration to an open configuration. For example, the operator may want to reposition the device or adjust the tension in the suture filament 912. Thus, the release tab 104 may be actuated as described above in Figures 1D-1E and 6A-6C, in which the release tab is rotated upward from a flat position to a vertical position, and then one end of the release tab contacts the housing, thereby rotating around its vertical axis to retract the plunger 106 from the housing 102 and realign the plunger suture slot with the housing suture slot. The device may then be repositioned or the tension in the suture may be adjusted.

[0091] Figure 9J shows that once the device is repositioned and the suture tension is adjusted to the desired level, the device can be reclosed. Here, the plunger is pushed back into the housing so that the housing suture slot is misaligned with the plunger suture slot, as previously described in Figures 9G-9H above.

[0092] Figure 9K shows the removal of the stop element 702 from the housing 102. After the suture and suture retention device are properly repositioned and the suture tension is readjusted, the user closes the plunger as described above. The suture filament is trapped within the suture retention device, and the free end of the suture filament extends from the housing, allowing the vascular access site to close and healing to begin. After the wound site is closed and any blood leakage from the wound site is stopped, the user can remove the stop element from the housing by lifting the cutter release tab 110 away from the protrusion in the housing and lifting the stop element away from the housing. The cutter element 114 is no longer constrained so as not to be actuated by being pushed inward into the housing.

[0093] Figure 9L shows the advancement of the cutter element 114 into the housing cutter channel. Here, the user pushes the cutter element 114 along the cutter channel into the housing, which causes the cutter blade to push against one of the free ends 912 of the suture filament, thereby cutting it.

[0094] Figure 9M shows a cross-sectional view of Figure 9L obtained along the longitudinal axis of the device, more clearly illustrating the cutting of the free ends of the suture filaments. Here, the free end of the filament closest to the cutter blade is cut by the blade 122 when the user pushes it along the channel 210 (best seen in Figure 2A) within the cutter element 114. The other free end remains intact and is not cut. In other embodiments, both free ends may be cut by one or more cutting blades. The cut free end is still attached to the suture retaining device because it is caught between the plunger and the housing, but the remainder of the free end is left in the tissue. The blade 122 is positioned very close to the bottom of the suture retaining device housing, and therefore, when the free end is cut, the amount of suture extending out of the tissue on its side is minimal, and the suture is then substantially coplanar with the patient's skin, or only 1 mm or less or 2 mm or less extends out of the skin. The less suture material remains, the easier it is to pull the suture through the skin during suture removal, which is quicker and less painful. Any other free end of the suture is also still attached to the suture retaining device, so that when the device is pulled upward and away from the patient, the suture filament is pulled out of the patient, ensuring that no suture remains inside the patient. Thus, cutting the free end of the suture allows the user to remove the suture from the wound. The user may be a physician or other healthcare worker in a clinic or hospital, or the user may be a patient removing the suture at home.

[0095] (Example of a seam pattern) Figures 10A–10D illustrate several embodiments of suture patterns that may be used in conjunction with a wound and one of the suture retention devices disclosed herein to help close the wound. These suture patterns are not intended to be limiting, and other suture patterns may be used.

[0096] Figure 10A illustrates a blood vessel V, such as a vein or artery, with an access site A formed within the vessel. The access site is the location where a guidewire, insertion device sheath, catheter, or other device is inserted into the blood vessel.

[0097] Figure 10B illustrates an embodiment of the figure-eight suture discussed above, and more clearly, the suture pattern. Here, the suture filament has a first free end 1002. The suture enters the tissue at point 1004, which is laterally away from the edge of the vessel, or adjacent to the vessel, and longitudinally adjacent to access site A. The suture passes through the tissue above the vessel (the suture does not pass beneath the vessel, otherwise, if the suture were stretched, it would crush the vessel), crosses 1006 across the vessel, and exits from the tissue 1008 at a position laterally away from the opposite edge of the vessel, or otherwise adjacent to the vessel, and longitudinally adjacent to access site A. The filament then crosses in the opposite direction 1010 across the access site, forming a first loop in a figure eight, and re-enters the tissue at point 1012, similarly positioned away from the edge of the vessel or adjacent to the vessel, longitudinally adjacent to the access site but axially offset from the first loop. Again, the filament passes through the tissue above the vessel, traversing the vessel 1014, and similarly positions laterally away from the vessel or, in a different manner, adjacent to the vessel, while longitudinally spaced adjacent to the access site but axially offset from the first loop, and exits the tissue at point 1016. The second free end 1018 may then pass across and traverse the access site, forming a second loop in a figure eight. The two free ends can then be bound together to close the suture, or any of the suture-holding devices disclosed herein may be used to fix the free ends, thereby forming the two loops and the figure eight pattern. When tension is applied to the free end and the loop in the suture closes, a compressive force, indicated by an arrow pointing inward toward the blood vessel, tightens the tissue and closes the wound and access site. Therefore, in this embodiment, the compressive force is applied in a direction transverse or perpendicular to the longitudinal axis of the blood vessel, and thus the compressive force is applied inward toward the longitudinal axis of the blood vessel.

[0098] Figure 10C illustrates a transverse figure-eight suture, which may also be called an infinite suture pattern. This is substantially identical to the aforementioned figure-eight pattern, the main difference being that the figure-eight suture is rotated 90 degrees either clockwise or counterclockwise, and the compressive force provided by the figure-eight suture is also rotated 90 degrees, so that it is directed inward toward the center point of the suture, along the longitudinal axis of the blood vessel.

[0099] As described above, blood vessels V, such as veins or arteries, have an access site A formed within the vessel. The access site is the place where a guidewire, insertion device sheath, catheter, or other device is inserted into the vessel.

[0100] In this embodiment, an infinite suture pattern is used to close a wound. It may be used in conjunction with any of the suture retention devices disclosed herein, or it may be tied manually. The infinite pattern may be used alone or in combination with a figure-eight pattern or any other suture pattern. The suture filament has a first free end 1042 that crosses from one edge of a vessel to the opposite edge of a vessel across the access site. The suture enters the tissue at point 1044, which is laterally adjacent to the edge of a vessel, or laterally away from the edge of a vessel and longitudinally adjacent to the access site A. The suture passes through the tissue above the blood vessel (the suture does not pass beneath the blood vessel; otherwise, if the suture were stretched, it would crush the vessel), then extends substantially parallel to the longitudinal axis of the blood vessel 1046, is axially displaced away from the initial entry point 1044, and exits from the tissue 1048 at a position laterally adjacent to or laterally away from the edge of the blood vessel. The filament then reverses 1050 across the access site and similarly re-enters the tissue at point 1052, which is positioned laterally adjacent to or laterally away from the edge of the blood vessel and longitudinally adjacent to the access site. Again, the filament passes through the tissue above the vessel, extending substantially parallel to the longitudinal axis of the vessel 1054, and similarly positioned laterally away from the edge of the vessel, or laterally adjacent to the edge of the vessel, while longitudinally spaced adjacent to the access site, but axially displaced away from the second insertion point 1052, at point 1056, it exits from the tissue. The second free end 1058 may then pass across and traverse the access site. The two free ends can then be bound together to close the suture, or one of the suture retention devices disclosed herein may be used to fix the free ends, thereby forming a transverse figure-eight pattern, also referred to as an infinite pattern. Tension is applied to the free ends, and when the loop in the suture closes, a compressive force, indicated by an arrow, oriented inward toward the access site and substantially parallel to the longitudinal axis of the vessel, tightens the tissue and closes the wound and access site.Therefore, in this embodiment, the compressive force is applied in a direction substantially parallel to the longitudinal axis of the blood vessel, and thus the compressive force is applied inward along the longitudinal axis of the blood vessel.

[0101] Figure 10D illustrates a combination of the figure-eight suture pattern described in Figure 10B and the infinite suture pattern described in Figure 10C, used to close an access site A within a blood vessel V. Here, two suture filaments are used to form two suture patterns, resulting in four free ends which can then be bound together to close the suture, or two pairs of free ends can be fixed using one or two suture retention devices, such as those described herein. Here, the figure-eight suture pattern 1078 and the infinite suture pattern 1076 are identical to those described above, and the corresponding detailed descriptions are not repeated for brevity. The resulting suture patterns are then properly stretched and closed, providing compressive forces in both axial directions: inward along the longitudinal axis of the blood vessel and inward toward the access site in directions transverse or perpendicular to the longitudinal axis of the blood vessel, as indicated by the arrows.

[0102] (Other embodiments of suture retention devices) Figure 11 illustrates an embodiment of the alternative plunger 1102 design. Here, the plunger 1102 is generally identical to the plunger 104 described above (see, for example, Figures 1B, 3, and 4), the main difference being that the surface-textured ribs or protrusions 308 on the upper and bottom surfaces of the plunger have been removed and replaced with a circumferential ring 1104, which is circumferentially positioned around the plunger and provides an interlocking fit between the plunger, the housing, and the suture filament, helping to prevent movement of the suture filament. The circumferential ring may be an O-ring or other soft elastic ring wrapped around the plunger adjacent to one or both of the plunger suture slots 306. In this embodiment, two circumferential rings are used. Other aspects of the plunger 1102 are generally identical to the plunger 104 described above. Plunger 1102 is used in the same manner as plunger 104 is used with housing 102, and therefore the method of use described in Figures 9A-9M and the stitch pattern described in Figures 10A-10D are also applicable to the use of plunger 1102. The plunger in Figure 11 may be used with any of the housings disclosed herein.

[0103] Figure 12 illustrates another embodiment of the suture holding device, comprising a plunger 1202 and a housing 1220 that work together to secure the suture filaments.

[0104] In Figure 12, the plunger 1202 includes an enlarged head region 1208 and an elongated, thinner cylindrical shaft 1204, forming a T-shaped plunger. The shaft 1204 includes one or more plunger suture slots 1206, which have elongated portions that are coupled to the enlarged head portion for holding suture filaments. Thus, the main difference between this embodiment and the aforementioned plunger 104 is that, instead of the thin rectangular plunger portion of plunger 104, the plunger is modified to replace, here, the rectangular plunger portion and the cylindrical plunger shaft. The cylindrical plunger shaft is received by a corresponding cylindrical channel within the housing, as seen in Figure 12B. Other aspects of the plunger are generally identical to those of plunger 104 and are omitted here for brevity. The plunger also includes a release tab, which may help to retract the plunger from the housing.

[0105] Figure 12 also shows an embodiment of a housing 1220 cooperating with the plunger 1202 shown in Figure 12A. Here, the housing 1220 includes a cylindrical plunger channel 1222 that may extend all the way through the housing, or the channel may be open only at the plunger receiving end (left side in Figure 12) and closed at the opposite end, so the channel is a blind hole. The housing suture slot 1224 is aligned with the plunger when the device is in the open position for receiving suture filaments, and misaligned when the device is in the closed position for securing the filaments. Other aspects of the housing and use are generally the same as those described above with respect to housing 102, and are therefore omitted for brevity. For example, the housing may include a cutter, a cutter stopper, and a cutter release tab.

[0106] (Other uses of suture retention devices) In the embodiments described above, the suture retention devices and suture patterns are described in terms of closing wounds after medical procedures on humans. This is not intended to be limiting. Those skilled in the art will understand that the suture retention devices and suture patterns can also be used on animals, or on cadavers, or on humans who have otherwise died. In addition, the suture retention devices and suture patterns may be used on non-tissue materials, e.g., foams, plastics, fruits, or any other materials (e.g., synthetic materials) used during practice or training sessions, and therefore any number of materials may be sutured, and the devices and methods described herein may be used. In addition, the devices and methods described herein may also be used to fix the free ends of any filaments, whether sutures or non-sutures, e.g., metal filaments, other polymer filaments, tissue filaments, etc. Therefore, the devices and methods disclosed herein can be used in any medical or non-medical application.

[0107] (Notes and examples) The following non-limiting embodiments elaborate on certain aspects of the subject matter, in particular, to solve at least some of the problems and to provide at least some of the benefits discussed herein.

[0108] Embodiment 1 is a suture holding device comprising a housing having a channel extending through it, and one or more housing suture slots disposed within the housing, each housing suture slot configured to receive one or more suture filaments, and a plunger having one or more plunger suture slots disposed within it, each plunger suture slot configured to receive one or more suture filaments, the plunger being slidably disposed within the channel of the housing, and the plunger having an open position and a closed position, in the open position, the plunger is The suture holding device is partially positioned within a channel, with one or more housing suture slots aligned with one or more plunger suture slots, allowing one or more suture filaments to slide through the one or more housing suture slots and one or more plunger suture slots; in the closed position, the plungers are positioned within the channel in a different position than in the open position, with one or more housing suture slots misaligned with one or more plunger suture slots, preventing one or more suture filaments from sliding through the one or more housing suture slots and one or more plunger suture slots.

[0109] Example 2 is the device described in Example 1, wherein in the closed position, the plunger is sized and shaped to create an interlocking fit between the plunger and the housing wall defining at least a portion of the channel and one or more suture filaments, the interlocking fit preventing the movement of one or more suture filaments through one or more plunger suture slots and one or more housing suture slots.

[0110] Example 3 is the device described in any of Examples 1-2, further comprising a textured surface on the upper or lower surface of the plunger, wherein the textured surface improves the tight fit.

[0111] Example 4 is a device according to any of Examples 1-3, wherein the housing has a vertical axis and the channel is parallel to the vertical axis.

[0112] Example 5 is a device according to any of Examples 1-4, wherein the housing has a longitudinal axis, and one or more housing suture slots or one or more plunger suture slots are oriented transversely to the longitudinal axis.

[0113] Example 6 is a device according to any of Examples 1-5, wherein one or more housing suture slots or one or more plunger suture slots are J-shaped.

[0114] Example 7 is a device according to any of Examples 1-6, wherein the housing further comprises a cutter channel and a cutting element slidably disposed within the cutter channel, the cutting element being configured to cut at least one of one or more suture filaments.

[0115] Example 8 is a device according to any of Examples 1-7, wherein the cutting element comprises a sharp blade coupled to a cutting block, the sharp blade being positioned at a certain angle to apply a shear cutting force to at least one of one or more suture filaments.

[0116] Example 9 is a device according to any of Examples 1-8, further comprising a stop element that is removably coupled to the housing, wherein the stop element is configured to prevent axial movement of the cutting element into the cutter channel.

[0117] Example 10 is a device according to any of Examples 1-9, further comprising a protrusion and a recess, wherein one of the protrusion or recess is formed within the housing, and the other of the protrusion or recess is formed within the cutting element, and the protrusion is received within the recess to prevent the cutting element from becoming detached from the housing.

[0118] Example 11 is a device according to any of Examples 1-10, further comprising a release tab coupled to the plunger, wherein the operation of the release tab applies force to the housing and facilitates the removal of the plunger from the channel.

[0119] Example 12 is a device according to any of Examples 1-11, wherein the release tab pivots upward and away from the upper surface of the plunger, and the release tab rotates about a central axis substantially perpendicular to the upper surface of the plunger.

[0120] Example 13 is a device according to any of Examples 1-12, further comprising one or more projections extending from the plunger, the one or more projections being configured to limit the rotation of the release tab about a central axis.

[0121] Example 14 is the device described in any of Examples 1-13, wherein the housing is clear to facilitate observation of one or more suture filaments or a plunger in a channel.

[0122] Example 15 is a device according to any of Examples 1-14, further comprising a protrusion and a recess, wherein one of the protrusion or recess is formed within the plunger, and the other of the protrusion or recess is formed within the housing, and the protrusion is received within the recess to prevent the plunger from coming out of the channel.

[0123] Example 16 is a device according to any of Examples 1-15, further comprising a substrate layer bonded to the bottom surface of the housing.

[0124] Example 17 is a device according to any of Examples 1-16, wherein the substrate layer comprises an adhesive configured to bond the housing to the patient's skin, or the substrate layer comprises a therapeutic agent configured to leach from there into the patient, or the substrate comprises a foam configured to reduce or eliminate trauma to the patient's skin when the device is placed against it.

[0125] Example 18 is a device according to any of Examples 1-17, wherein the therapeutic agent is configured to reduce pain or to reduce or eliminate infection.

[0126] Example 19 is a method for fixing suture filaments, comprising: slidably positioning the suture filaments in one or more plunger suture slots located within a plunger; slidably positioning the suture filaments in one or more housing suture slots located within a housing; applying tension to the suture filaments; and moving the plunger into a channel within the housing such that one or more plunger suture slots are misaligned with one or more housing suture slots, thereby trapping the suture filaments between the plunger and the housing and preventing the suture filaments from moving relative to the plunger and the housing.

[0127] Example 20 is the method according to Example 19, further comprising applying tension to the suture filament, wherein the trapping of the suture filament maintains the tension within the suture filament.

[0128] Example 21 is a method according to any of Examples 19-20, further comprising cutting suture filaments using a cutter element slidably disposed within a cutter channel in a housing.

[0129] Example 22 is the method according to any of Examples 19-21, further comprising removing the catheter or sheath from the blood vessel before cutting the suture filaments.

[0130] Example 23 is a method according to any of Examples 19-22, wherein cutting the suture filament includes removing a stop element positioned between the cutter element and the housing, thereby allowing the cutter to advance toward the housing and cutting the suture filament.

[0131] Example 24 is a method according to any of Examples 19-23, wherein the suture filament comprises a first free end and a second free end, and cutting comprises cutting only one of the first free end and the second free end.

[0132] Example 25 is a method according to any of Examples 19-24, wherein the cutting includes cutting the suture filament such that it is substantially coplanar with the bottom wall of the cutter channel in the housing.

[0133] Example 26 is a method according to any of Examples 19-25, further comprising removing the plunger from the plunger channel in the housing, thereby aligning one or more housing suture slots with one or more plunger suture slots, thereby releasing the suture filaments from being trapped between the plunger and the housing, and allowing the suture filaments to move relative to the plunger and the housing.

[0134] Example 27 is a method according to any of Examples 19-26, wherein removing the plunger includes rotating a release tab on the plunger relative to the housing, thereby retracting the plunger from the housing.

[0135] Example 28 is the method according to any of Examples 19-27, further comprising inserting a suture filament into the tissue adjacent to the vascular access site.

[0136] Example 29 is a method according to any of Examples 19-28, wherein inserting a suture filament into the tissue includes forming a figure-eight suture using the suture filament.

[0137] Example 30 is a method according to any of Examples 19-29, wherein the suture filament, when formed in a figure-eight shape, comprises two loops and two free ends, one or more plunger suture slots comprising a first plunger suture slot located within the plunger and a second plunger suture slot located within the plunger, one or more housing suture slots comprising a first housing suture slot located within the housing and a second housing suture slot located within the housing, the first of the two free ends being located within the first plunger suture slot and the first housing suture slot, and the second of the two free ends being located within the second plunger suture slot and the second housing suture slot.

[0138] Example 31 is a method according to any of Examples 19-30, further comprising bonding the housing to the patient using a substrate bonded to the bottom surface of the housing.

[0139] Example 32 is a method according to any of Examples 19-31, wherein the base material is a soft, elastic material that prevents or reduces trauma to the patient when a housing is bonded thereto.

[0140] Example 33 is a method according to any of Examples 19-32, wherein the substrate comprises a therapeutic agent, and the method further includes eluting the therapeutic agent from the substrate into the patient.

[0141] Example 34 is a method according to any of Examples 19-33, wherein the therapeutic agent comprises an analgesic for reducing pain or an antibiotic for reducing infection.

[0142] In Example 35, any one or any combination of the devices, systems, or methods from Examples 1-34 may be configured such that all listed elements or options are available for use or selection from there.

[0143] The above detailed description includes references to accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention may be put into practice. These embodiments are also referred to herein as “Examples.” Such embodiments may include elements in addition to those illustrated or described. However, the inventors also envision embodiments in which only those elements illustrated or described are provided. Furthermore, the inventors also envision embodiments that use any combination or arrangement of those elements illustrated or described (or one or more aspects thereof), either relating to a particular embodiment (or one or more aspects thereof) illustrated or described herein, or to other embodiments (or one or more aspects thereof).

[0144] In the event of any conflict between usage in this book and any other document resulting from such incorporation, the usage in this book shall prevail.

[0145] In this text, the terms “a” or “an” are used to include “one or more than one,” independently of any other instance or usage of “at least one” or “one or more,” as is common in patent documents. In this text, the term “or” is used to mean “non-exclusive or,” such that “A or B” includes “A but not B,” “B but not A,” and “A and B.” In this text, the terms “including” and “in which” are used as plain English equivalents of the individual terms “comprising” and “wherein.” Furthermore, in the following claims, the terms “including” and “comprising” are non-restrictive; that is, systems, devices, articles, compositions, formulations, or processes that include elements in addition to those enumerated after such terms in the claim are still considered to fall within the scope of that claim. Also, in the following claims, the terms “first,” “second,” and “third,” etc., are used merely as labels and are not intended to impose numerical requirements on them.

[0146] The above description is intended to be illustrative, not restrictive. For example, the embodiments (or one or more aspects thereof) described above may be used in combination with one another. Other embodiments may also be used by those skilled in the art, subject to a scrutiny of the above description. The abstract is provided to enable the reader to quickly confirm the nature of the technical disclosure. It should be considered with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features may be grouped together for the sake of brevity of the disclosure. This should not be interpreted as meaning that any disclosed feature not claimed is essential to any claim. Rather, the subject matter of the invention may be less than all the features of a particular disclosed embodiment. Accordingly, the following claims are incorporated in this specification as examples or embodiments within the detailed description, and each claim stands independently as a separate embodiment, and it is assumed that such embodiments may be combined with one another in various combinations or rearrangements. The scope of the invention should be determined by reference to the appended claims, along with the full range of equivalents enjoyed by such claims.

Claims

1. A suture retention device, A housing, wherein the housing has a channel extending through it, One or more housing suture slots arranged within the housing, wherein each of the one or more housing suture slots is configured to receive one or more suture filaments, A plunger, wherein the plunger has one or more plunger suture slots disposed therein, the one or more plunger suture slots are configured to receive the one or more suture filaments, the plunger is slidably disposed within the channel of the housing, and the plunger has an open position and a closed position. Equipped with, In the open position, the plunger is partially positioned within the channel, and the one or more housing suture slots are aligned with the one or more plunger suture slots, allowing the one or more suture filaments to slide through the one or more housing suture slots and the one or more plunger suture slots. A device in which, in the closed position, the plunger is positioned in the channel differently from that in the open position, and one or more housing suture slots are misaligned with one or more plunger suture slots, thereby preventing one or more suture filaments from sliding through the one or more housing suture slots and the one or more plunger suture slots.

2. In the closed position, the plunger is sized and shaped to create an interlocking fit between the plunger, the wall of the housing defining at least a portion of the channel, and the one or more suture filaments, the interlocking fit preventing the movement of the one or more suture filaments through the one or more plunger suture slots and the one or more housing suture slots, according to claim 1.

3. The device according to claim 1, further comprising a textured surface on the upper or lower surface of the plunger, wherein the textured surface improves the interference fit.

4. The device according to claim 1, wherein the housing has a vertical axis and the channel is parallel to the vertical axis.

5. The device according to claim 1, wherein the housing has a vertical axis, and one or more housing suture slots or one or more plunger suture slots are oriented laterally with respect to the vertical axis.

6. The device according to claim 1, wherein the one or more housing suture slots or the one or more plunger suture slots are J-shaped.

7. The device according to claim 1, wherein the housing further comprises a cutter channel and a cutting element slidably disposed within the cutter channel, the cutting element being configured to cut at least one of the one or more suture filaments.

8. The device according to claim 7, wherein the cutting element comprises a sharp blade coupled to a cutting block, the sharp blade being positioned at a certain angle to apply a shear cutting force to at least one of the one or more suture filaments.

9. The device according to claim 7, further comprising a stop element detachably coupled to the housing, wherein the stop element is configured to prevent axial movement of the cutting element into the cutter channel.

10. The device according to claim 7, further comprising a protrusion and a recess, wherein one of the protrusion or the recess is formed within the housing, the other of the protrusion or the recess is formed within the cutting element, and the protrusion is received within the recess to prevent the cutting element from becoming detached from the housing.

11. The device according to claim 1, further comprising a release tab coupled to the plunger, wherein the operation of the release tab applies force to the housing and facilitates the removal of the plunger from the channel.

12. The device according to claim 11, wherein the release tab pivots upward and away from the upper surface of the plunger, and the release tab rotates about a central axis substantially perpendicular to the upper surface of the plunger.

13. The device according to claim 12, further comprising one or more protrusions extending from the plunger, wherein the one or more protrusions are configured to limit the rotation of the release tab about the central axis.

14. The device according to claim 1, wherein the housing is clear to facilitate observation of one or more suture filaments or observation of the plunger in the channel.

15. The device according to claim 1, further comprising a protrusion and a recess, wherein one of the protrusion or the recess is formed within the plunger, the other of the protrusion or the recess is formed within the housing, the protrusion is received within the recess, and the device prevents the plunger from coming out of the channel.

16. The device according to claim 1, further comprising a base material layer bonded to the bottom surface of the housing.

17. The device according to claim 16, wherein the base layer comprises an adhesive configured to bond the housing to the patient's skin, or the base layer comprises a therapeutic agent configured to leach therefrom into the patient, or the base comprises a foam configured to reduce or eliminate trauma to the patient's skin when the device is placed against it.

18. The device according to claim 17, wherein the therapeutic agent is configured to reduce pain or to reduce or eliminate infection.

19. A method for fixing suture filaments, The suture filament is slidably positioned in one or more plunger suture slots located within the plunger, The suture filament is slidably positioned in one or more suture slots located within the housing, Applying tension to the suture filament, The one or more plunger suture slots are misaligned with the one or more housing suture slots, thereby trapping the suture filament between the plunger and the housing, and moving the plunger into the channel within the housing to prevent the suture filament from moving relative to the plunger and the housing. Methods that include...

20. The method according to claim 19, further comprising applying tension to the suture filament, wherein the capture of the suture filament maintains the tension within the suture filament.

21. The method according to claim 19, further comprising cutting the suture filament using a cutter element slidably disposed within a cutter channel in the housing.

22. The method according to claim 21, further comprising removing the catheter or sheath from the blood vessel before cutting the suture filaments.

23. The method according to claim 21, wherein cutting the suture filament includes removing a stop element disposed between the cutter element and the housing, thereby allowing the cutter to advance toward the housing and cutting the suture filament.

24. The method according to claim 21, wherein the suture filament comprises a first free end and a second free end, and the cutting comprises cutting only one of the first free end and the second free end.

25. The method according to claim 21, wherein the cutting includes cutting the suture filament such that it is substantially coplanar with the bottom wall of the cutter channel in the housing.

26. The method according to claim 19, further comprising removing the plunger from the plunger channel in the housing, thereby aligning the one or more housing suture slots with the one or more plunger suture slots, thereby releasing the suture filament from being trapped between the plunger and the housing, and enabling the movement of the suture filament relative to the plunger and the housing.

27. The method according to claim 26, wherein removing the plunger includes rotating a release tab on the plunger relative to the housing, thereby retracting the plunger from the housing.

28. The method according to claim 19, further comprising inserting the suture filament into the tissue adjacent to the vascular access site.

29. The method according to claim 28, wherein inserting the suture filament into the tissue includes forming a figure-eight suture using the suture filament.

30. When the suture filament is formed in the figure-eight shape, it comprises two loops and two free ends. The one or more plunger suture slots comprise a first plunger suture slot located within the plunger and a second plunger suture slot located within the plunger. The one or more housing suture slots include a first housing suture slot located within the housing and a second housing suture slot located within the housing. The first of the two free ends is positioned in the first plunger suture slot and in the first housing suture slot. The method according to claim 29, wherein the second of the two free ends is positioned within the second plunger suture slot and within the second housing suture slot.

31. The method according to claim 19, further comprising bonding the housing to a patient using a substrate bonded to the bottom surface of the housing.

32. The method according to claim 31, wherein the base material is a soft elastic material, and the soft elastic material prevents or reduces trauma to the patient when the housing is bonded thereto.

33. The method according to claim 31, wherein the substrate comprises a therapeutic agent, and the method further comprises eluting the therapeutic agent from the substrate into the patient.

34. The method according to claim 33, wherein the therapeutic agent comprises an analgesic for reducing pain or an antibiotic for reducing infection.

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