# Patent

## Title
Vascular suturing device

## Abstract

A surgical device for suturing vascular vessels is described, as well as methods for suturing tissue employing the surgical device. The device includes a distal member for insertion into a vascular vessel puncture wound. The distal member contains a suture and needle engaging fitting. At least one needle is advanced through tissue adjacent the puncture wound and into the needle engaging fitting to draw lengths of suture material which can then be used to close the puncture wound.

## Background
BACKGROUND OF THE INVENTION
The present invention generally relates to surgical instruments and methods of suturing tissue.
A number of diagnostic and treatment procedures are conducted intravascularly. Typically, a catheter is introduced into the vascular system at a convenient access location and is then guided to the target treatment site. The Seldinger Technique is one of the well-known early examples of this type of procedure which can include catheterization and angioplasty techniques. Procedures such as this require a vascular access. Typically an introducer sheath with or without a guide wire is inserted through a puncture wound in a vessel such as the femoral artery at a location near the groin. A catheter and other instrumentation can then be inserted through the sheath and guided to the targeted treatment site. After the diagnostic and/or treatment procedure has been completed, the puncture wound must be closed. Closing the wound can be difficult because of the substantial bleeding that can occur through an open wound in the vascular vessel. One technique for hemostasis includes applying pressure near or upstream of the puncture site. This approach suffers from many deleterious effects, not the least of which are that it can be time consuming and extremely uncomfortable—even painful—for the patient because the pressure is applied directly on or adjacent to the traumatized site. Frequently anticoagulants are employed for the original diagnostic/treatment procedures. This delays clot formation during the procedure, and this effect lasts through the initial recovery period, lengthening the time during which pressure must be applied to the wound for up to twelve hours or more. During this initial recovery period, it is imperative that the patient remain still, further adding to the patient's discomfort.
Alternatively, the puncture wound can be closed with sutures. This can be extremely difficult because the vascular vessel with the puncture lies underneath the patient's outer skin. Some vascular vessels, notably the femoral artery, appear to be relatively large; however, in practice, even the largest arteries cannot be readily sutured. Therefore, devices have been developed to facilitate subcutaneous suturing of arteries and veins. These devices can extend through the outer tissue to the puncture wound in the vascular vessel. Needles are then deployed from the device to suture the tissue adjacent the puncture wound.
Certain devices are inserted subcutaneously into the puncture wound. One or more needles are deployed to pierce the tissue in a direction from the exterior to the interior of the vascular vessel. The needles continue to be advanced into a depository in the portion of the device located within the lumen of the vessel. The suturing device can be removed from the vessel (and the patient) by withdrawing the needles and suture material at the same time. These devices leave an inverted suture path after completion of the closure. The suture material runs from the exterior tissue surrounding the puncture wound back up through the wound itself which is then tied off. Some complications may arise resulting from this type of closure, including oozing, excessive bleeding, and, on rare occasions, knot loosening. It would be preferred to provide a suturing device that allows the suture path to extend across the puncture opening internal of the vessel membrane with the suture knot overlying the exterior of the closed wound.
In view of the above background, there remains a need for improved and/or alternative methods and devices for closing the vascular opening or punctures. The present invention is addressed to these needs.
SUMMARY OF THE INVENTION
The present invention relates to suturing devices and the use thereof. Various aspects of the invention are novel, nonobvious, and provide various advantages. While the actual nature of the invention covered herein can only be determined with reference to the claims appended hereto, certain forms and features, which are characteristic of the preferred embodiments disclosed herein, are described briefly as follows.
In one form, the present invention provides a suturing device for suturing an opening in a vascular vessel. The device comprises a proximal member that can be configured as an elongate body with a needle channel extending at least partway therethrough and sized to receive at least one needle; a distal member configured to be inserted within a lumen of a vascular vessel, where the distal member has a receptacle located therein and a length of suture material with a needle engaging fitting positioned in the receptacle; and an intermediate member disposed between the proximal member and the distal member. In one embodiment, the intermediate member defines a tissue receiving area and has a first opening providing a passageway to the channel and a second opening providing a passageway into the receptacle. In other embodiments, the distal member defines a substantially linear longitudinal axis and the intermediate member can deviate from that longitudinal axis. In other embodiments, the intermediate defines a tissue receiving area that provides a linear needle pathway through the tissue receiving area.
In another form, the present invention provides a suturing device for suturing an opening in a vascular vessel. The suturing device comprises: a proximal member including an elongate body having a needle channel therethrough sized to receive at least one needle and including a needle cartridge slidably mounted thereon configured to contain two or more needles; a distal member configured to be inserted within a lumen of a vascular vessel and having a receptacle located therein and a length of suture material with a needle engaging fitting positioned in the receptacle; an intermediate member disposed between the proximal member and the distal member, where the intermediate member defines a tissue receiving area and has a first opening providing a passageway to the channel and a second opening providing a passageway into the receptacle. and a length of suture material comprising a needle engaging fitting positioned in the receptacle to engage a needle entering from the second opening.
In yet another form, the present invention provides A method of suturing an opening in a vascular vessel, said method comprising: inserting a vascular suturing device through the opening in the vascular vessel, said suturing device comprising a proximal member having a needle channel and a needle therein; a distal member configured to be inserted into the lumen of the vascular vessel, the distal member having a cavity therein and a length of suture material disposed in the cavity; and a connecting member between the proximal and distal members, the connecting member angled or curved to offset the channel and the cavity from the opening in the vascular vessel and having a first opening into the needle channel and a second opening into the cavity; sufficiently advancing the needle through the needle channel to pierce a portion of tissue adjacent the opening in the vessel and extend into the cavity of the distal member; and capturing the suture within the cavity with the needle; and retracting the needle carrying a first portion of the suture back through the tissue and the channel.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded view of one embodiment of a suturing device in accordance with the present invention.
FIG. 1A is an illustration of suture material suitable for use in the suturing device of FIG. 1 accordance with the present invention.
FIG. 2 is a cross-sectional view of the suturing device of FIG. 1 including the suture material of FIG. 1A.
FIG. 3 is a perspective view of a ferrule and a needle for use with the suturing device in accordance with the present invention.
FIG. 4 is a cross-sectional view of the ferrule engaged with the needle of FIG. 3.
FIG. 5 is an enlarged, cross-sectional view of the intermediate member of the suturing device of FIG. 1 with the suture material of FIG. 1A.
FIG. 6 is a radial cross-sectional view taken along section line 6-6 of the intermediate member illustrated in FIG. 5.
FIG. 7 is an enlarged cross-sectional view of an alternative embodiment of a connector member with suture material and two laterally disposed ferrules in accordance with the present invention.
FIG. 8 is a perspective view of an alternative embodiment of a suturing device with a needle cartridge for use in accordance with the present invention.
FIGS. 9-16 illustrate the use of the suturing device of FIG. 1 to suture vascular tissue.
FIG. 17 is a perspective view of a hollow needle for use in the suturing devices described herein.
FIGS. 18-20 illustrate the use of the suturing device of FIG. 1 with a hollow needle of FIG. 17.
FIG. 21 is a perspective view of one embodiment of a suture securing device for use in the present invention.
FIG. 22 is a perspective view of an alterative embodiment of a suture securing device for use in the present invention.



DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is an exploded view of one embodiment of a suturing device 10 for suturing vascular vessels in accordance with the present invention. Device 10 includes a proximal member 12, a distal member 14, and an intermediate member 16 located therebetween. Device 10 includes one or more needles 18 advanceable through a portion of the proximal and distal members. A needle pusher 26 can either push or engage needle 18 to advance it through a channel 24 in the proximal member and through vascular tissue adjacent the puncture wound. In one form, suture material can be attached to needle 18 which is then advanced in a distal direction through tissue. In other forms, suture material can be located within distal member to be snared by a needle to be withdrawn in a proximal direction through tissue. A second needle and subsequent needles can be similarly configured and manipulated to place sutures through tissue adjacent a puncture wound in a vascular vessel. The suture material(s) threaded through the vascular tissue can be drawn taut closing the puncture wound. A surgical knot or other suture securing device can complete the wound closure.
As used herein, the term “proximal” refers to a direction toward the surgeon and away from the patient or a location closer to the surgeon, while the term “distal” refers to a direction towards the patient and away from the surgeon or a location closer to the patient.
Proximal member 12 is provided as an elongated portion with a substantially cylindrical or oval radial cross section. Member 12 includes a first end of sufficient dimensions to be readily grasped by the surgeon to manipulate the device during the procedures. Proximal member 12 can also include a gripping portion to facilitate handling during the surgical procedure. Needle channel 24 runs longitudinally along at least a portion of proximal member. In one embodiment, channel 24 extends along the entire length of proximal member from a first end positioned proximal to the surgeon to a second end adjacent to intermediate member 16. In this embodiment, one or more needle(s) 18 and needle pusher(s) 26 can be inserted into and retrieved from channel 24 at the first end. In other embodiments, channel 24 extends only partly through the proximal member 12. Needle channel 24 can be centrally located along proximal member 12. In preferred embodiments, proximal member 12 includes a single needle channel 24 through which one, two, three, or more needles can be advanced. Alleviating multiple needle channels within the suturing device provides a more compact member, which can be particularly advantageous for subcutaneous procedures.
Channel 24 is sized and dimensioned to allow one or more needles 18 to be advanceable therethrough and into vascular tissue around the puncture wound. Furthermore, channel 24 can be either partly or completely encased within the body of proximal member 12. However, in a preferred embodiment, channel 24 is not encased within the body of proximal member 12. Rather, channel 24 is provided as a slot formed into the surface of proximal member 12. Preferably the slot is configured to retain one or more needles within the slot. For example, the slot can be formed to have an opening at the exterior surface of proximal member that is narrower than the diameter of the needles (and optionally the pusher) while the internal portion or diameter of the slot can be dimensioned to permit facile movement of the needle therethrough. An exit opening is located at the distal end of channel 24.
Proximal member 12 includes a blood return line or lumen 25 that terminates in a fitting 27, for example, a luer lock that can be mated to a syringe. Alternatively, blood return lumen 25 can terminate in a valve or shunt to control and stop blood flow therethrough. It is preferable that blood return lumen 25 be transparent to allow visible observation of blood originating from inside the vascular vessel. This can facilitate proper placement of the device for suturing.
Distal member 14 is sized and/or configured to be received within an opening or wound leading to a lumen of a patient's vascular vessel. Therefore, it is preferable that at least distal member 14 be formed of a flexible or elastomeric material that is biocompatible—particularly with blood. In a preferred embodiment, proximal member 12 and distal member 14 define a longitudinal axis. In additional embodiments, distal member 14 can be coated or impregnated with a lubricant, bioactive agent, such as an anticoagulant material, and the like. In certain embodiments, distal member 14 is composed of a biocompatible polymeric material commonly used for catheters, such as silicone rubber, polyolefin polyurethane, polytetrafluoroethylene, and the like.
FIG. 1A illustrates one or more lengths of suture material 20 that can be included in receptacle 22 of distal member 14 in accordance with one embodiment of the present invention. The lengths of suture material 20 can include one or more fittings 21, 23, for example, a ferrule or cuff of porous or mesh material, to engage the needle.
Distal member 14 includes a receptacle 22. Receptacle 22 is sized to receive at least one length of suture material 20 with a corresponding fitting 21, as specifically shown in FIG. 2. Preferably receptacle 22 is sized to hold one, two, or more separate lengths of suture material. Each length of suture material can include either a single fitting 21 or two fittings—one on each end. In a preferred embodiment, receptacle 22 is provided as a multi-stage or tapered recess. Each fitting is positioned within a receptacle to allow for ready deployment and subsequent engagement with needle 18 advancing from channel 24 in proximal member 12. Preferably the fittings are releasably retained so that needles advancing into receptacle 22 can sequentially engage the fittings without forcing that fitting distally further or deeper into the receptacle. In one form, this can include a shoulder or abutment 30 extending from the internal wall of receptacle 22 to abut a distal end of a fitting. In other embodiments, this can include configuring the internal dimensions of receptacle 22 to taper or decrease in diameter in the distal direction. In other embodiments, a multi-stage receptacle 22 or stepped internal walls receptacle 22 can prevent movement of the fittings in the distal direction. In still other embodiments, the fittings are loaded within the receptacle 22 to bear against the suture material which is packed within the end of receptacle 22. In this embodiment, the bulk of suture material in receptacle 22 can inhibit or prevent distal movement of the fittings upon initial engagement with needle 18.
FIGS. 3 and 4 illustrate a portion of needle 18 and fitting 21 in the form of a ferrule 44. Needle 18 includes a distal tip 32 and a proximal end 34. Distal tip 32 is configured as a tissue piercing point or a barbed tip. Needle 18 is configured to grab suture material located in the lumen of the vessel and withdraw the suture material through vascular tissue. In the preferred embodiment, distal tip 32 is configured to securely engage with ferrule 44 which, in turn, is attached to a length of suture. Ferrule 44 can be extremely small, having roughly a diameter similar to or slightly larger than that of the suture material 20. Alternatively, ferrule 44 can have approximately the same diameter as the diameter of needle shaft 35. In this embodiment, distal tip 32 has a smaller diameter to allow it to be received inside ferrule 44. Distal needle tip 32 includes at least one recessed engagement surface or shoulder 37 configured to matingly engage with a corresponding engagement surface 38 provided on or in ferrule 44. In one form, the engagement surface is a tab extending into the interior of ferrule 44. In other embodiments, the engagement surface is a shoulder extending radially inward in ferrule 44 or a groove partly or completely encircling an interior wall of ferrule 44. Fitting 23 also may be in the form of a ferrule 46 shown in FIGS. 5 and 6. Ferrule 46 may have similar needle retention features.
FIGS. 5 and 6 show that the ferrules 44 and 46 need not be the same size—particularly the same diameter. In this regard certain advantages can be gained by providing the proximally located ferrule 44 with a diameter greater than that of the distally located ferrule 46. For example, this will allow sufficient room for the suture material extending from ferrule 44 to extend along side of ferrule 46—between ferrule 46 and an internal wall section of receptacle 22. In other considerations, the suture material from the proximally located ferrule 44 can be disposed between that ferrule and the next distally located ferrule 46. Ferrules 44 and 46 can also be tapered or “streamlined” to allow them to be readily pulled through a small needle puncture site in tissue as described below.
In one embodiment, the length of suture material which is attached to the different ferrules on each end can include different color codings for the different ends. This allows a surgeon to differentiate which sutures are attached to which ferrules to facilitate tying suitable knots to close puncture 96 in the vessel.
One or more of needles 18 and ferrules 44, 46 for use in the present invention can be provided as substantially described in U.S. Pat. No. 6,136,010 issued to Modesitt et al. and/or U.S. Pat. No. 6,368,334 issued to Sauer, which are incorporated herein by reference in their entirety.
Proximal end 34 of needle 18 can be free and configured to be handled by a surgeon. Alternatively, proximal end 34 can be engageable or secured to a needle pusher 26 shown in FIG. 2. In yet another embodiment, proximal end 34 can be integral or formed as a single unit with needle pusher 26. In either embodiment, needle pusher 26 is sized to be positioned within channel 24 and can further include a projection 36 to allow the surgeon to advance the needle pusher/needle combination along channel 24. In a preferred embodiment, needle pusher 26 is configured such that the surgeon can sequentially advance needle 18 in a proximal direction towards the patient and in a distal direction away from the patient.
Referring back to FIG. 2, distal member 14 can also include a lumen 39 extending at least partially therethrough. Preferably, lumen 39 is separate from receptacle 22. Lumen 39 can be provided to receive or follow a guide wire left in place after a particular diagnostic or treatment procedure. This can allow the facile insertion of distal member 14 into the patient's vascular vessel. In a preferred embodiment, an opening 40 receives a guide wire (not shown) that extends through lumen 39 and exits through a side opening 41 of distal member 14 to permit the guide wire to extend out without interfering with the needles, needle path, or suture material. The guide wire can be removed after placement of the suture device or left in as desired or considered medically prudent by the surgeon.
Intermediate member 16 is located between proximal member 12 and distal member 14. Intermediate member 16 defines a tissue-receiving area 45. In the illustrated embodiment, intermediate member is configured to include an arcuate portion or a crooked section. The arcuate portion or crook thus defines a concave interior surface 47 and a convex exterior surface 48. Intermediate member 16 includes a first opening 50 providing access from the channel 24 to the tissue receiving area 45 and a second opening 52 from the receptacle 22 providing to the tissue receiving area 45. Preferably, first and second openings 50 and 52 are linearly or axially aligned. Intermediate member 16 can be composed of a biocompatible material that is substantially resistant to deformation and therefore can maintain the linearity between channel 24 and receptacle/chamber 22 and the respective first and second openings 50 and 52. Examples of suitable materials include TEFLON, NYLON, polyamids, and the like.
Intermediate member 16 also includes means and structure for reliable positioning of the device during surgery to facilitate closing the vascular puncture wound with sutures. Part of the positioning structure includes an opening 54 providing fluid communication to blood return lumen 25 in proximal member 12. In a preferred embodiment, opening 54 is located on a portion of the convex surface of the crook opposite the tissue receiving area 45. When the distal member 14 of the device is suitably positioned within the lumen of a vascular vessel, opening 54 is also located in the interior of the lumen. This permits blood from the vessel to enter blood return lumen 25, which can then be visibly observed by the surgeon. If blood is not observed in blood return lumen 25, then the distal member may not have been inserted to a sufficient depth into the lumen of the vascular vessel.
Additionally, a ridge or stop 56 extends from the concave surface into the tissue receiving region. Stop 56 is configured to bear against vascular tissue adjacent the puncture wound. In a preferred embodiment, first opening 50 is adjacent stop 56 permitting needle 18 to pierce tissue adjacent thereto. Stop 56 is sized to bear against the vascular tissue and avert further insertion of the device 10 into the vascular vessel. When provided together, stop 56 and opening 50 with blood return lumen 25 cooperate to ensure accurate placement of the suturing device in the patient's vascular vessel. Ridge or stop 56 can also extend radially about the entire circumference of intermediate member 16.
FIG. 7 is a cross-sectional view of an intermediate member 70 of an alternative embodiment of a suture device. In this embodiment, fittings 72 and 73 are positioned radially or laterally displaced from each other in receptacle 74. A first fitting 72 is positioned axially aligned with second opening 75 in the distal member 76. A biasing element such as a leaf spring 77 can also be positioned in receptacle 74 to urge second fitting 73 into axial alignment with opening 75 once first fitting 72 has been displaced. Biasing element 77 can be a leaf spring as illustrated, an elastomeric projection, or other known biasing material suitable to urge fitting 72 into alignment as desired. FIG. 8 is a perspective view of another embodiment of a suturing device 80 with a needle cartridge in accordance with the present invention. Device 80 includes a proximal member 81, a distal member 82, and an intermediate member 83 therebetween. Proximal member 81 includes a needle cartridge 84 slidably mounted in body 85. Needle cartridge 84 can include a plurality of needle slots, for example one, two, three, or more slots 86a. 86b, 86c . . . , each for a separate needle. Typically, the number of needles in needle cartridge 84 will coincide with the number of fittings with suture material in the receptacle in distal member 82. Each needle in needle cartridge 84 is individually advanceable through a central needle channel 87 along a length of proximal member 81. Needle cartridge 84 is laterally displacable within body 85 to axially align the selected needle slot 86a. 86b, 86c . . . with a single needle channel. If desired, needle cartridge can be biased to automatically align the successive needle slots with the needle channel after the preceding needle has been advanced along the channel. Alternatively, suturing device 80, body 120, and/or cartridge 118 can include one or more of ratchetings, positive stops, or locks to individually align the desired needle slot with the channel. In other embodiments, needle cartridge 84 can be provided as a revolving barrel that can hold two, three, or more needles in respective needle slots radially disposed about the barrel. The barrel can be rotatably mounted on or about proximal member 81. Distal member 82 and intermediate member 83 can be configured substantially as described above for members 14 and 16, respectively.
Referring to FIGS. 9 through 14, use of the suturing device 10, will now be described. A puncture wound in a vascular vessel can be sutured closed using the suturing device 10. Suturing device 10 can be inserted distally into the vascular vessel. This can be accomplished with or without the use of a guide wire. In a procedure where a guide wire has been previously used, suturing device 10 can be threaded onto a guide wire 92 which extends from internal vessel lumen 94 through a puncture wound 96 in vessel 93 and through a portion of the overlying tissue 95 to be exposed to the surgeon. In that regard, side opening 41 of lumen 39 can be threaded onto guide wire 92 which then extends out through opening 40. Thus, the flexible portion of distal member 14 can be gingerly threaded into the lumen 94 of vessel 93. The distal member 14 of device 10 can be positioned within lumen 94 such that intermediate member 16 engages with a portion of the tissue surrounding puncture 96. Distal member 14 is advanced in a distal direction until blood is observed in blood return lumen 25. Additionally, when provided, stop 56 abuts or bears against the external surface of the vascular vessel. This can be detected by the increased resistance to further advancement of the device in the distal direction. Both blood return lumen 25 and stop 56 can be used to ascertain that the device has been correctly positioned within the lumen 94 of the vascular vessel 93 to allow suturing of puncture 96. It should be noted that observance of blood in needle channel 24 is an indication that device 10 has been inserted too far into the lumen such that first opening 50 is exposed to the interior or blood side of vessel 93. If desired, guide wire 92 can then be withdrawn from lumen 39 and out of vascular vessel 93—if it is no longer needed for subsequent procedures.
After the distal member 14 is positioned as desired, the vascular tissue adjacent the puncture wound is received within the tissue receiving area 45. As noted above, intermediate member 16 provides an essentially linear needle pathway between channel 24, receptacle 22, and the vascular tissue in the tissue receiving area 45. Consequently, when needle 18 is advanced through channel 24, it pierces the vascular tissue at a first suture site 97 adjacent the puncture wound 96.
FIG. 10 illustrates suturing device 10 at a first suture position with needle 18a advancing distally through channel 24 and piercing the vascular tissue of vessel 93 at a first suture site 97 on a first side of wound 96. From there, needle tip 32 advances into to receptacle 22 to engage in a first ferrule 44. Once engaged with ferrule 44, first needle 18a can then be withdrawn back through opening 52 in distal member 14 and through first suture site 97, drawing a length of suture material 20 through the vascular tissue in a proximal direction as illustrated in FIG. 11. Preferably the needle path in the proximal direction is the same as in the distal direction—provided that the suturing device has not been moved or dislocated. Needle 18a, including a length of suture material 20 can then be removed from suture device 10. Alternatively, needle 18a and/or a length of suture material can be retained with suture device 10 for subsequent retrieval and use in securing the wound closure.
Thereafter, suture device 10 is rotated into a second suture position as illustrated in FIG. 12. For example, suture device 10 may be rotated approximately 180° so that in the second suture position, suture device 10 is positioned to operate on a second side of puncture 96 diametrically opposite first suture site 97. After ensuring that the suturing device is correctly positioned, the procedure described above for needle 18a can be followed. At the second suture position, a second needle 18b is distally advanced using a needle pusher, either the same needle pusher or a second, different needle pusher, through channel 24 to engage in and pierce the vascular tissue 93 received within tissue receiving area 45 at second suture site 99. Again, needle 18b is advanced to enter receptacle 22 and there engage with second ferrule 46 as shown in FIG. 13. Withdrawal of the needle pusher concomitantly withdraws ferrule 46, and a length of suture 20 through second suture site 99 as shown in FIG. 14. Needle 18b and the attached ferrule 46 and length of suture material can be retrieved by the surgeon either by hand or received within a slot in the proximal member. Thereafter, if desired, the process can be repeated, rotating suturing device 10 through about 90° and again, advancing a needle to engage in a subsequent ferrule located in receptacle 22. This process can be repeated as desired and as provided with a number of needles and/or suture materials with ferrules in receptacle 22. It will be understood that in one embodiment, first and second lengths of suture materials are two ends of the same suture. In other embodiments, lengths of suture material are separate pieces of suture. Thereafter, device 10 can be withdrawn from the body as illustrated in FIG. 15.
As illustrated in FIGS. 16 the lengths of suture material 20 can be gathered. The length of suture material can be separated from the needles. Pulling the lengths of suture material taut closes the wound 96 in the vessel 93. In this embodiment, the path of the suture material passes through vascular tissue on a first side of the wound into the lumen 94 of the vessel 93, across the wound 96—again in the lumen 94—and then out through the vascular tissue 93 on a second or opposite side of the wound. A surgical knot can be tied securing the wound closure. A knot pusher, for example, the knot pushers described in U.S. Pat. No. 5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755 issued to Wood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be used to advance the loosely tied knot to the exterior surface of the vascular vessel. In selected embodiments, the surgeon can then tie a suitable surgical knot using the respective lengths of suture material to close the puncture wound 96. In other embodiments, the suture material can be secured using a variety of knot replacement technologies such as that disclosed in U.S. patent application Ser. No. 10/164,606 (U.S. Patent Publication No. 2003/0229377) and in Ser. No. 10/305,923 (U.S. Patent Publication No. 2004/0102809) and depicted in FIGS. 21 and 22. Each of the above-noted references are incorporated by reference in their entirety.
FIG. 17 is a perspective view of one embodiment of a hollow needle 88 for use in accordance with the present invention. Needle 88 includes a detachable tip 89, a hollow shaft 90, and a length of suture material 91. The length of suture material 91 extends out the proximal end of hollow needle 88. In one embodiment, one end of the suture material 91 is attached to needle tip 89. In this embodiment, the needle tip 89 can be used to pull suture material 91 through a portion of a suturing device or through vascular tissue as discussed more fully below. FIGS. 18 through 20 illustrate the use of hollow needles with the suturing device 10. The suturing device 10 is inserted into the vascular vessel as described above and illustrated in FIG. 9. After suturing device 10 has been positioned within the lumen 94 as desired, needle 88 is advanced in the distal direction through needle channel 24 to pierce vascular tissue 93 adjacent the wound 96 in the vessel and then into recess 22 to engage with a first ferrule 44. Needle 88, the attached ferrule 44, and a length of suture material 20 are withdrawn in the proximal direction back through the needle path through a first suture site.
Suturing device 10 can be rotated about its longitudinal axis while maintaining the distal member within the vascular lumen to a second suturing position. FIG. 19 illustrates the advancement of hollow needle 88 along channel 24. Hollow needle 88 can pierce vascular tissue 93 at a second suture site. Needle tip 89 can then engage with the second ferrule 46 located in receptacle 22. Once engaged to second ferrule 46, needle tip 89 can be separated from shaft 90 by withdrawal of the needle shaft 90 back through the second suture site. The needle shaft can be received in or through channel 24. Suture material 91 is then connected to suture material 20 via ferrule 46 and needle tip 89. Suturing device 10 can then be removed from the vascular vessel and eventually from the patient.
Referring now FIG. 20, suture material 20 and 91 are connected together using second ferrule 46 and needle tip 89. The connected suture material can be pulled in either direction by 1) pulling on suture material 20 in the distal direction to draw ferrule 46, needle tip 89, and a portion of suture material 91 through the second suture site, or 2) pulling on suture material 91 in the distal direction to draw ferrule 46, needle tip 89, and a portion of suture material 20 through the second suture site. In yet other embodiments, the free ends of suture material 20 and 91 can be pulled taut to close the vascular wound. Preferably in this embodiment both of needle tip 89 and ferrule 46 (as well as the suture materials) are composed of a biodegradable material to biodegrade. Biodegradable materials for the ferrule, needle tips, and suture material are well known in the art and these materials are useful to prepare the components of the present invention.
FIG. 21 is a perspective view of a suture securing device 102 for use in the present invention. Suture clamping device 102 is described and illustrated in U.S. Patent Publication No. 2004/0102809 which is incorporated herein by reference. In use, device 102 can secure ends of one, two, three or more lengths of suture material. Two lengths of suture material 104a and 104b are illustrated with device 102. The lengths of suture material are threaded into the flexible elements 105a and 105b which are then locked or fixed together clamping the suture material therein. FIG. 22 shows another embodiment of suture clamping devices 106a and 106b for use in the present invention. Devices 106a and 106b are described in U.S. Patent Publication No. 2003/0229377 which is incorporated herein by reference in its entirety. Devices 106a and 106b cooperate by separately clipping onto a selected length of suture material 104a or 104b which have previously pulled taut to close the wound 96 or complete the surgical procedure. The devices prevent the suture material from regressing back through the sutured tissue.
The present invention provides a variety of means, devices and methods for closing wounds in tissue and is particularly, but not exclusively, suitable for vascular tissue. It will be understood that the present invention contemplates modifications as would occur to those skilled in the art without departing from the spirit of the present invention. In addition, where the various structures, elements, and procedural steps or stages have been described with reference to a specified embodiment and device. Each of the individual or a combination of the structures, elements, and procedural steps or stages are contemplated to be combinable with each of the other embodiments and devices described herein and as such are contemplated to be within the scope of the present invention.
Further, all publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and set forth in its entirety herein. Further, any theory of operation, proof, or finding stated herein is meant to further enhance understanding of the present invention and is not intended to make the scope of the present invention dependent upon such theory, proof, or finding.

## Claims

1. A suturing device for suturing an opening in a vascular vessel, said device comprising: a proximal member including an elongate body having a needle channel therethrough sized to receive at least two hollow needles; a distal member configured to be inserted within a lumen of a vascular vessel, said member having a receptacle, wherein the receptacle is elongate, located therein; an intermediate member disposed between the proximal member and the distal member, said intermediate member defining a tissue receiving area and having a first opening providing a passageway to the needle channel and a second opening providing a passageway into the receptacle; a length of suture material having two needle engaging fittings, each of the two needle engaging fittings being positioned in the receptacle to engage at least one of the at least two hollow needles entering from the second opening, one of the two needle engaging fittings being disposed proximal to the other needle engaging fitting within the receptacle, wherein the two needle engaging fittings in the receptacle have differing cross-sectional diameters and are axially displaced from each other, a distal-most needle engaging fitting being smaller in cross-sectional diameter than a proximal-most needle engaging fitting, the receptacle in said distal member is being substantially in line with the longitudinal axis of said needle channel and the intermediate member deviates from the longitudinal axis.

2. The device of claim 1 wherein the needle engaging fitting comprises ferrule having a needle engaging tab.

3. The device of claim 2 wherein the ferrule comprises a cylindrical housing having a plurality of tabs extending radially into the cylindrical housing.

4. The device of claim 2 wherein each of the at least two hollow needles comprises a recessed engaging surface configured to engage with the needle engaging tab.

5. The device of claim 1 wherein the length of suture material comprises a first needle engaging fitting on a first end and a second needle engaging fitting on a second end.

6. The device of claim 1 wherein the receptacle is substantially circular or oval in cross section and the two needle engaging fittings are radially displaced from each other.

7. The device of claim 1 wherein the proximal member contains a single needle channel extending therethrough.

8. The device of claim 1 wherein said receptacle has an abutment to limit the distal movement of said needle engaging fitting.

9. The device of claim 1 wherein the proximal member comprises a needle cartridge having a plurality of slots configured to slidably receive the at least two hollow needles.

10. The device of claim 9 wherein the cartridge is slidably mounted on the proximal member to sequentially align one of the slots with the needle channel.

11. The device of claim 1 further comprising a needle pusher slidably mounted in alignment with the needle channel to advance the at least two hollow needles along the channel in a direction toward the first opening in the connecting member.

12. The device of claim 1 wherein the at least two hollow needles further comprise a length of suture material extending at least partly therethrough.

13. The device of claim 1 wherein the connecting member is curved or angled to define a tissue receiving recess configured to receive a portion of vascular tissue adjacent the opening in the vascular vessel.

14. The device of claim 1 wherein at least a portion of the distal member is flexible.

15. The device of claim 1 wherein the connecting member is rigid.

16. A suturing device for suturing an opening in a vascular vessel, said device comprising:
a proximal member including an elongate body having a needle channel therethrough sized to receive at least one hollow needle and including a needle cartridge slidably mounted thereon configured to contain a plurality of hollow needles;
a distal member configured to be inserted within a lumen of a vascular vessel, said member having a receptacle located therein;
an intermediate member disposed between the proximal member and the distal member, said intermediate member defining a tissue receiving area and having a first opening providing a passageway to the channel and a second opening providing a passageway into the receptacle;
a length of suture material having two needle engaging fittings, each of the two needle engaging fittings being positioned in the receptacle to engage the at least one hollow needle of the plurality of hollow needles entering from the second opening, a first needle engaging fitting of the two needle engaging fittings being disposed proximal to the other needle engaging fitting within the receptacle, the first needle engaging fitting having a cross-sectional diameter greater than that of the other needle engaging fitting.

17. The device of claim 16 wherein each needle engaging fitting comprises a ferrule having a needle engaging tab.

18. The device of claim 17 wherein the ferrule comprises a cylindrical housing having a plurality of tabs extending radially inward.

19. The device of claim 16 wherein the at least one hollow needle comprises a recessed engaging surface configured to engage with the needle engaging tabs.

20. The device of claim 16 wherein the proximal member contains a single needle channel extending therethrough.

21. The device of claim 16 wherein the connecting member is curved or angled to define a tissue receiving recess configured to receive a portion of vascular tissue adjacent the opening in the vascular vessel.

22. The device of claim 16 comprising a needle pusher slidably mounted in alignment with the needle channel to advance the at least one hollow needle of the plurality of needles along the needle channel in a direction toward the first opening in the connecting member.