Apparatus and method for minimally invasive suturing

[0001] This application is related to U.S. patent application Ser. No. 11/231,135, filed Sep. 20, 2005, which claims the benefit of priority to U.S. Provisional Application Ser. No. 60/611,362, filed Sep. 20, 2004. This application is also related to U.S. Provisional Application Ser. No. 60/939,887, filed May 24, 2007. Each of these applications is incorporated by reference herein in its entirety.

[0002] Minimally invasive surgery (MIS) has allowed physicians to carry out many surgical procedures with less pain and disability than conventional, open surgery. Unlike conventional open surgery, where the surgical site is readily accessible through a large incision, enabling the surgeon to easily visualize and manipulate both tissue and instruments, MIS requires the surgeon to operate remotely by inserting and manipulating instruments through small punctures (“keyhole surgery”) or through natural orifices, including the vagina, the esophagus, or the anus.

[0003] In MIS, a small puncture is typically made in the body. Medical instruments are then inserted through a cannula. A cannula has a small inside diameter, typically 5-10 millimeters (mm), and sometimes up to 20 millimeters (mm) or more. A number of such cannulas are inserted into the body for any given operation. Minimally invasive surgical instruments are necessarily smaller, and are also generally longer and therefore are more difficult to manipulate with precision.

[0004] Perhaps the most problematic surgical task in MIS is suturing. Suturing requires coordinated manipulation with both hands of small needles and sutures that are difficult to visualize (particularly when only indirect, two-dimensional video imaging is available) as well as the several instruments (including needle-drivers and pick-up forceps) ordinarily used to suture by hand. In an environment characterized by limited space, limited visualization, and limited mobility, many surgeons find minimally invasive suturing by hand an extremely difficult, often virtually impossible, surgical task.

[0005] In the preferred method of suturing by hand, a grasping forceps (“needle driver”) is held by the surgeon and is used to grip a curved needle near the needle's tail. Pronation of the surgeon's wrist drives the needle into the tissue. When the point of the curved needle emerges from the tissue, the surgeon releases the needle from the grip of the needle driver and grasps the point with another forceps (“pick-ups”). The surgeon then pulls the curved needle by the needle point, preferably in a circular path following the arc of the needle's curvature to follow the most atraumatic path through the tissue, until the entire length of the needle has exited the tissue. Each time a stitch is placed, the curved needle is thus driven around in a complete circular arc. Individual (interrupted) stitches are placed by tying off the suture following the placement of each stitch. Running (continuous) stitches are placed by repeatedly driving the curved needle in a complete circular arc repeatedly until the desired length of suture and number of stitches has been placed. In order to place additional interrupted or continuous stitches, the surgeon must let go of the point of the needle and re-grasp the needle near the needle's tail.

[0006] In the manual suturing technique described above, the direct handling of the needle can result in accidental needle pricks through a surgeon or nurse's gloves, posing a potential risk of infection for the surgeon, nurse, staff, and patient, or cause the needle to become contaminated with pathogenic bacteria that can cause onset of infection at the site of the sutures. There is also a risk of the needle penetrating internal organs or vessels and causing a serious, and often fatal infection.

[0007] Various devices for suturing for MIS are described in U.S. Pat. No. 5,643,295 entitled “Methods and Apparatus for Suturing Tissue”; U.S. Pat. No. 5,665,096 entitled “Needle Driving Apparatus and Methods of Suturing Tissue”; U.S. Pat. No. 5,665,109 entitled “Methods and Apparatus for Suturing Tissue”; U.S. Pat. No. 5,759,188 entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 5,860,992 entitled “Endoscopic Suturing Devices and Methods”; U.S. Pat. No. 5,954,733 entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 6,719,763 entitled “Endoscopic Suturing Device”; and U.S. Pat. No. 6,755,843 entitled “Endoscopic Suturing Device”, all of which are incorporated by reference in their entireties for the teachings therein.

[0008] Assignees' U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705 and U.S. Pat. No. 6,923,819 disclose a suturing device with thread management comprising a protective cartridge, suturing needle and needle rotation drive, the disclosures of which are hereby incorporated by reference. The devices described in the above-mentioned patents and patent application comprise a mechanism for driving a protected needle however, the needle is rotated about an axis that is parallel to the axis of the device. In addition, the orientation and size of the suturing device makes it difficult to visualize and cumbersome to use for MIS.

[0009] Therefore, there remains a need in the art for a minimally invasive suturing device that is easily manipulated within the small diameter of the cannula; functions in an environment characterized by limited space, limited visualization, and limited mobility; mimics the preferred method of suturing used by surgeons; permits the surgeon to secure and tie knots quickly and with controlled tension; places continuous stitches; and protects user's from accidental needle sticks during needle handling, as well as internal organs and vessels, from inadvertent needle-pricks.

[0010] Advantages of the present invention will be set forth in and become apparent from the description that follows. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

[0011] To achieve these and other advantages and in accordance with the purpose of the invention, as embodied herein, the invention includes a needle loader. The needle loader includes a generally planar needle supporting surface, a hub configured and adapted for receiving a generally toroidally shaped suturing needle around the hub, and means for retaining a suturing needle in a fixed toroidal rotational position with respect to the hub about a center axis of needle rotation. Generally, a needle mounted around the hub is selectively disposable on and removable from the hub.

[0012] In accordance with a further aspect, the loader may further include an opening for retaining suture material attached to a suturing needle. The opening may include a groove defined through the needle supporting surface. The needle loader may further include a guard for preventing access to the point of a suturing needle to protect the needle and/or to prevent accidental needle sticks. The needle loader may further include a generally toroid-shaped needle disposed on the needle loader. The needle may include suture material attached thereto. In accordance with one embodiment, the loader, needle and suture may be disposed in sterilizable packaging. In accordance with a preferred embodiment, the hub may be adapted and configured to be received by a portion of a suturing device. The needle loader preferably includes medical grade sterilizable polymeric material.

[0013] The invention also provides a system. The system includes a suturing device. The suturing device includes an elongate body having a suturing head at a distal end thereof, the suturing head defining a tissue receiving gap, wherein the suturing device is adapted and configured to direct a generally toroid-shaped needle in a circular track around the tissue receiving gap. The system also includes a needle loader. The needle loader includes a generally planar needle supporting surface, a hub configured and adapted for receiving a generally toroidally shaped suturing needle around the hub, means for retaining a suturing needle in a fixed toroidal rotational position with respect to the hub, wherein a needle mounted around the hub is selectively disposable on and removable from the hub, and a generally toroid-shaped needle disposed on the needle loader.

[0014] In accordance with one embodiment of the system, the hub is preferably adapted and configured to be received by the tissue receiving gap of the suturing device to facilitate transfer of the needle from the needle loader to the suturing device. The loader and needle may be disposed in sterilizable packaging. Furthermore, a portion of the suturing device may be adapted to be received by a gap defined between the needle and the loader.

[0015] The invention also provides a method. In accordance with one embodiment, the method includes the step of providing a suturing device as described above. The method further includes providing a needle loader having a needle mounted thereon, as described herein. The method also includes the step of transferring the needle from the needle holder to the suturing device. If desired, the hub of the needle loader may be inserted into the tissue receiving gap of the suturing device, and a portion of the suturing device may be displaced to retain the needle to facilitate transfer of the needle to the suturing device.

[0016] It is to be understood that the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed. The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the drawings serve to explain principles of the invention.

[0022] Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the invention will be described in conjunction with the detailed description of the system.

[0023] Devices made in accordance with the related patent applications as incorporated by reference herein require the use of suturing needles that are advanced about a circular track. While these needles (having sutures attached) can be installed manually either before or during a surgical procedure, it is advantageous to provide devices and methods to make installation of these needles into the suturing devices both easier and safer. Accordingly, the instant disclosure provides exemplary devices and techniques for loading needles into such suturing devices.

[0024] For purposes of illustration and not limitation, as illustrated in FIGS. 1-2, in accordance with one embodiment, a needle loader 100 is provided that is adapted and configured to load a suturing needle into a suturing device such as that described in U.S. patent application Ser. No. 11/231,135.

[0025] As depicted, needle loader 100 includes a generally planar proximal region 110 and a distal region 120. Proximal region includes a proximal end 112, a distal end 114 and generally planar opposed faces 116, 118. An operating room technician or nurse can grip loader 100 by the opposing faces 116, 118 to facilitate loading a needle 200 into a suturing device. If desired, faces 116, 118 may be textured to enhance gripping. As will be appreciated by those of skill in the art, proximal region 110 can be any suitable shape (e.g., having a round, elliptical, rectangular or other cross-section) and need not be generally planar. However, use of a generally planar proximal region is preferred for ease of manufacturing and use.

[0026] As depicted, distal region 120 of needle loader includes a needle supporting surface 130 a retainer block 140 and hub 150 for holding a needle 200 in position. The needle defines a center axis of rotation of needle C that passes through hub 150. As depicted, block 140 and hub 150 cooperate to define a needle retention channel 152 for receiving needle 200. If desired, a further extended bearing surface 142 may be included. In accordance with a preferred embodiment, needle 200 is installed into loader 100 by an interference fit between hub 150 and bearing surface 142. The interference fit retains suturing needle 200 in a fixed toroidal rotational position with respect to hub 150. The tolerance between needle 200 and loader 100 is preferably sufficient to prevent needle 200 from falling out if the loader is inverted, but still sufficient to permit needle 200 to be removed with relative ease during installation. As further depicted in FIG. 2, a suture retention groove 160 is defined in the distal end 122 of the distal region 120 of the loader 100 groove 160 is adapted and configured to receive a suture 250 therein to maintain the orientation of suture 250 (and of needle 200) when installing needle in a suturing device using loader 100.

[0027] With further reference to FIG. 2, if desired, inclined surfaces 170 may be provided to facilitate mating of the loader with a suturing device 10 (as depicted in FIGS. 3 and 4). As further depicted in FIG. 2, a guard may be provided to protect the point of needle 200 from damage, and to prevent accidental needle sticks while handling loader 100. Needle 200 is thus preferably placed in a rotational orientation with respect to loader 100 that places the point of the needle 200 behind the guard.

[0028] FIGS. 3(a)-3(f) and 4(a)-4(f) depict exemplary use of loader 100 with respect to a suturing device 10. FIGS. 3(a)-3(f) depict exploded views of loader 100 with respect separated from suturing device 10. By way of contrast, FIGS. 4(a)-4(f) depict views of loader 100 inserted into suturing device 10. In order to install a needle, retractable cover portion 12 of suturing device 10 is retracted proximally in order to expose a circular track into which needle 200 is to be installed. Next, loader 100 is inverted and aligned with a tissue receiving gap 150 defined in the distal end of the suturing device. Specifically, block 140 and hub 150 are received by the tissue receiving gap 150, such that the needle 200 is aligned with and received by the semicircular needle track of the suturing device 10. Next, the cover 12 is advanced distally to cover at least a portion of the needle 200, preventing the needle from being withdrawn with the loader 100. If desired, distal portions 12a, 12b of cover 12 can engage surfaces 170 of loader to help drive needle off of loader 100. Stated another way, distal portions 12a, 12b can be received by the gap 175 defined between needle 200 and surfaces 170. The loader 100 is then withdrawn, leaving the generally toroidal suturing needle 200 installed in the suturing device 10. Suture 250 is removed from groove 160, cover 12 is advanced into its distal position, and suturing device 10 is ready for use.

[0029] It will be appreciated that loader 100 can operate in a variety of manners. For example, it will be appreciated by those of skill in the art that loader 100 can be configured to selectively release needle 200 into a needle track, such as by configuring loader 100 to be flexed by an operator to cause channel 152 to widen, thereby releasing needle. Similarly, a pusher can be provided (such as in the form of a pin terminating in a button) disposed in an opening defined through loader 100 into track 152 (not depicted).

[0030] It will be further appreciated by those of skill in the art that loader can take on a variety of other configurations to accomplish a similar result. For example, instead of a groove 160, a hole (not depicted) can be provided to guide suture 250. However, it will be recognized that a groove 160 is preferred for ease of use, since the entire length of suture 250 need not pass through groove 160 after installing needle 200 in a suturing device 10. However, use of a hole instead of a groove would require that the entire length of suture 250 be pulled through the hole. By way of further example, if desired, planar portion 110 of loader can be provided with a layer of resilient material (e.g., foam or elastomeric material) to receive a used suturing needle to facilitate disposal and to reduce risk of needle sticks from used needles.

[0031] Loader 100 is preferably made from a resilient material (e.g., a polymeric material) that permits a suitable interference fit for needle 200. In accordance with one embodiment, loader is made from medical grade sterilizable polymeric material. However, it will be appreciated that any suitable material may be used to make loader 100. Loader 100 may be made with any known manufacturing techniques known by those of skill in the art, such as injection molding, stamping and the like. Needle 200 may be installed in loader 100 in a variety of ways. For example, needle 200 may be installed manually. In accordance with another embodiment, needle 200 may be installed automatically by a suitably machine adapted and configured for such a particular purpose.

[0032] For purposes of further illustration and not limitation, as embodied herein, in accordance with a further embodiment, a packaged medical device is provided including a loader, a needle, and suture material. As depicted in FIG. 5, the loader 100, needle 200 and suture material 250 can form the components of a sterile kit 300, packaged in appropriate plastic/reinforced paper material 310, 320, which preferably can be peeled open to lay out the components onto a sterile field. The top web 310 of the package can be thermoformable transparent plastic film, such as polyamide/polyethylene or polypropylene/polyethylene. This allows the contents of the sealed package to be visible. The bottom web 320 can be sterilizable paper or similar material, such as Tyvek® material, with a basic weight of about 60 gm/m² or more, allowing it to be permeable to sterilizing gas, so that the loader 100, needle 200 and suture material 250 can be sterilized from within the package. The top and bottom webs 310, 320 are sealed along the periphery of the package using a suitable adhesive or other means. The package 300 preferably can be opened by hand, using peel-open corners and peelable seams 330. It will be recognized by those of skill in the art that proximal portion 110 of loader 100 may be shortened to facilitate packaging loader as described herein.

[0033] The methods and systems of the present invention, as described above and shown in the drawings, provide for improved techniques for loading suturing needles into suturing devices. It will be apparent to those skilled in the art that various modifications and variations can be made in the device and method of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the subject disclosure and equivalents.