CN110809436A

CN110809436A - Crimping and suturing device apparatus and method

Info

Publication number: CN110809436A
Application number: CN201880042192.9A
Authority: CN
Inventors: 托马斯·萨尔温特
Original assignee: Intelligent Suture Co Ltd
Current assignee: Intelligent Suture Co Ltd
Priority date: 2017-08-17
Filing date: 2018-08-10
Publication date: 2020-02-18
Also published as: EP3547933A1; CA3049920A1; WO2019036301A1; BR112019021268A2; JP2020531054A; EP3547933A4; MX2019012168A

Abstract

The present invention provides a suturing device for minimizing interference and snagging during complex surgery. The crimped suturing device is significantly shorter than conventional suturing kits and is characterized by the attachment of a needle to a specialty thread that includes a stop mechanism before the angled semi-rigid portion of the thread, followed by a crimped portion of the thread arranged in a helical configuration. When the needle and the thread intermediate the needle and the stop mechanism are pulled through the suture spot, the stop mechanism stops the movement of the thread, thereby securing the remainder of the thread for access. Thus, the semi-rigid portion of the wire is used in conjunction with the coiled portion of the wire thereof to enable the user to access the helical configuration in an undeniable manner to form a ready knot, thereby minimizing interference and snagging during surgery. The wire may be manufactured to form additional semi-rigid portions of the wire and additional crimped portions of the wire when the knot is formed.

Description

Crimping and suturing device apparatus and method

[ Cross-reference to related applications ]

My priority application entitled "crimp seaming Apparatus and Method" filed on 8/17 2017, serial No. 15/679,978, the entire disclosure of which is incorporated herein by reference and the priority of which is claimed herein.

Technical Field

The present invention provides a suturing device for minimizing interference and snagging during complex surgery. Crimping a suturing device is significantly shorter than conventional suture kits by providing a needle attached to a specialty thread that includes a stopping mechanism (stopping mechanism) before the angled semi-rigid portion of the thread followed by a crimped portion of the thread arranged in a helical configuration (cockcroew configuration). When the needle and the wire intermediate the needle and the stop mechanism are pulled through the suture point (stitch point), the stop mechanism stops the movement of the wire, thereby securing the remainder of the wire for access by the user. Thus, the use of a semi-rigid portion of wire in combination with a coiled portion of its wire enables a user to access the helical configuration in an unreduced manner to form a ready-to-use knot (ready-male knot), thereby minimizing interference and snagging during surgery. The wire may be manufactured to form additional semi-rigid portions of the wire and additional crimped portions of the wire when the knot is formed.

Background

In laparoscopic surgery (laproscopic surgery) or other similar surgical procedures (procedure), a healthcare provider may be required to work within a particular cavity of a patient's body. While working in this lumen, instruments (e.g., a camera, instruments that hold the lumen open in a suitable manner, and multiple sutures (sutures) and associated wires that enable repair of internal tissue) may be inserted into the patient to enable a healthcare provider to perform the surgical procedure. The use of these instruments eventually crowds the healthcare provider's workspace and interferes with successful and effective surgical procedures.

By providing the crimped suturing device of the present invention with a special thread that enables the formation of a ready-made knot or ready-made knots, a healthcare provider can perform suturing with only one hand, while his or her second hand can secure a camera used during a surgical procedure, for example. Furthermore, by eliminating the need to manually form knots from standard sutures, the thread can be significantly shortened from the needle to the tip and thus free space within the surgical cavity. The angled semi-rigid portion of the wire, in combination with its corresponding crimped portion of the wire, concentrates the suture field in a convenient section of the surgical cavity, which enables the healthcare provider to operate within his or her field of view within the surgical cavity. The arrangement will also enable less adjustment of the position of the camera, which in turn reduces disruption (disraption) of both the surgical procedure and the patient's anatomy. The stop mechanism further contributes to these advantages as it enables the healthcare provider to more easily form the knot by ensuring that the crimped section of the suture remains in place during the suturing process. In addition, by enabling the healthcare provider to control both the suture and the tissue being sutured with a single hand, the healthcare provider is able to adjust the final suture location as necessary without causing additional damage to the tissue and the surgical cavity.

As summarized below, various references provide for crimping on sutures. However, the prior art does not provide a stop mechanism on the wire or any angled semi-rigid portion of the wire for more effectively suturing the desired area when used in conjunction with the crimped portion of the wire. Thus, the prior art does not effectively aid the healthcare provider during laparoscopic surgery. In addition, the prior art does not contemplate the various stop mechanisms that should be considered when customizing the suturing device for a particular surgical procedure.

For example, U.S. publication No. 2009/0216268, published by godien G pante (Gideon G. pater) on 27/8/2009, discloses a suture thread that includes a length of suture material secured to a needle to facilitate knotting. At least a portion of the length of suture material is resiliently biased into a coiled state (i.e., capable of being straightened under an applied stress), but returns to its coiled state when released. In use, a portion of the suture material is pulled through a tissue region such that portions of the suture material are located on opposite ends of the tissue. Next, a knot is formed in the suture material by passing one of the portions through at least one elastically shaped loop formed in the other of the portions and tensioning the suture material.

This discussion of a pander suture uses coiled wire to help form the knot, but does not provide a stop mechanism on the wire or on any angled semi-rigid portion of the wire that can be used in conjunction with the provided coil. Such a construction would be necessary to form a knot at the appropriate location of the suturing device, and would also help the healthcare provider draw the tissue regions together without damage while suturing.

United states patent No. 5,454,834 to manfrede bobayer et al, 10/3/1995 discloses a surgical suture material provided with a wire and, in some cases, a needle, to enable knots to be formed with the greatest possible safety with little effort, even in situations where space is limited, such as during endoscopic surgical procedures. The suture material has at least one inherently stable loop, loop or similar preformed feature in at least one initial preformed section (preformed section) of its length. To form the loop and/or knot, another section of wire or one end of the wire may be passed or guided through this preformed feature. For example, the preform segment may take the form of a preform feature having an approximately helical shape (helical shape).

However, like the pander suture disclosed above, this bobayer patent does not provide a stop mechanism on the thread or on any angled semi-rigid portion of the thread that can be combined with the provided loops for effective suturing. Moreover, the bobayer patent requires that multiple preformed sections of wire (i.e., coils) be present at the same time as each other, which would only further crowd the suture space, rather than simplify and streamline the suturing process as contemplated by the present invention.

Accordingly, there is a need for a crimping suturing device that helps reduce interference during a surgical procedure by providing a tailored suture that provides a ready knot or ready knots (including an angled semi-rigid portion of wire and a corresponding crimped portion of wire), and this is further facilitated in part by a stop mechanism in the wire that helps form the knot by securing the ready knot in a suitable area during the surgical procedure. Since the healthcare provider is enabled to suture suitable tissue with only one hand, the healthcare provider can also easily adjust the position of the suture and the knot to be formed within the surgical cavity, which enables to reduce the interference within the surgical cavity.

Disclosure of Invention

The present invention provides a suturing device for minimizing interference and snagging during complex surgery, such as laparoscopic surgery. The crimped suturing device is significantly shorter than other suture kits currently available because of the feature of attaching a suture needle to the end of a purpose-made suture that includes a specially placed stop mechanism immediately before and after the angled semi-rigid portion of the thread is a corresponding crimped portion of the thread arranged in a helical configuration that forms several loops before ending. The stop mechanism is used to stop the movement of the wire as the needle and the wire intermediate the needle and the stop mechanism are pulled through the suture site, thereby securing the remainder of the wire to the first side of the tissue being sutured. The angled semi-rigid portion of the wire immediately following the stop mechanism is used in conjunction with its corresponding crimped portion of the wire, thereby enabling the healthcare provider to access the helical formation (which enables a ready knot to be formed in the suturing device) in an undeniable manner to help minimize interference and snagging during surgery. The suture may be manufactured to automatically form additional angled semi-rigid portions of the thread and corresponding crimped portions of the thread when forming the previous knot, enabling the above process to be repeated to form additional knots as necessary for the requirements of the healthcare provider. The length of the entire device (from the tip of the suture needle to the end of the specialized suture) is significantly shorter than the length of a typical suture kit (which can extend up to several feet), which also helps to reduce interference and snagging during the surgical procedure.

The present invention solves the existing problems in the surgical field, namely provides a suturing device: the suturing device assists in suturing the block organization by enabling the formation of additional ready-made knots (including the angled semi-rigid portion of the thread and the corresponding crimped portion of the thread) by forming pre-existing knots, and also assists the healthcare provider in forming knots during the suturing process by providing additional features, such as different stop mechanisms and lengths of thread, to further refine and simplify the suturing process.

Drawings

Reference will now be made to the drawings, wherein like elements are designated by like numerals, and wherein:

fig. 1A is a diagram of a patient schematically depicting an operating area.

Fig. 1B is a patient diagram schematically depicting an operating field in which surgical instruments are inserted.

FIG. 1C is a view of a laparoscopic procedure being performed utilizing the crimping suturing device of the present invention.

FIG. 1D is a view of a laparoscopic procedure being performed to form a knot in the surgical field using the crimped stapling device of the present invention.

FIG. 2A is a schematic view of a crimping and suturing device according to one embodiment of the present invention.

FIG. 2B is a schematic view of a crimping and suturing device according to a second embodiment of the present invention.

FIG. 2C is a schematic view of a crimping and suturing device according to a third embodiment of the present invention.

FIG. 3A is a detailed view of a method of suturing two tissue masses starting from within a first tissue mass using the crimping suturing device of the present invention.

FIG. 3B is a detailed view of a method of suturing two pieces of tissue starting from the outside of the first piece of tissue using the crimping suturing device of the invention.

FIG. 4 is a detailed view of a method of suturing two pieces of tissue to thereby join the pieces of tissue using the crimping suturing device of the present invention.

FIG. 5 is a detailed view of a method of suturing two tissue masses using the crimping suturing device of the present invention to form a first knot joining the tissue masses.

FIG. 6 is a detailed view of a method of suturing two tissue blocks using the crimping suturing device of the present invention to form a second knot joining the tissue blocks.

FIG. 7 is a detail view of the resulting combination of the two knots used to engage a tissue mass using the crimping suturing device of the present invention.

FIG. 8 is a detail view of the resulting combination of the two knots used to engage a tissue mass using the crimping suturing device of the present invention that enables the formation of additional knots to engage the tissue mass with additional frictional force

Detailed Description

Referring to fig. 1A to 1D, there is shown a laparoscopic surgery using the crimping suture device 100 of the present invention. As shown in fig. 1A and 1B, a patient 200 may require a surgical procedure (e.g., laparoscopic surgery as depicted) and will have a particular surgical cavity 210 in which a healthcare provider will perform the surgical procedure, inserting various instruments 310 to perform their respective intended functions as needed during the course of the surgical procedure. For example, as shown in FIG. 1C, a patient 200 having a surgical cavity 210 can have

instruments

310A, 310B, and 310C inserted into the surgical cavity 210 in a suitable manner to set the surgical field, thereby enabling a healthcare provider to effectively perform the surgical procedure.

As shown in fig. 1C and 1D, which depict a typical laparoscopic surgical procedure, there is a camera 320 focused on a suitable area of the surgical cavity 210. This camera 320 enables the healthcare provider to view the appropriate area of the surgical cavity 210 on a screen 330, the screen 330 being formatted to depict the appropriate area of the surgical cavity 210. However, the camera 320 is inherently limited in scope and will only be able to draw a limited field of view of the surgical cavity 210 on the screen 330. Thus, if the healthcare provider needs to see additional areas within the surgical cavity 210, he or she will need to continually adjust the various instruments 310 and cameras 320 accordingly to view the appropriate areas of the surgical cavity 210 (which may be disruptive to the surgical procedure and the anatomy of the patient 200), or otherwise operate outside the viewing area of the cameras 320 (which may cause problems during the surgical procedure).

However, when using the crimping suturing device 100 of the present invention, the camera 320 is able to present the full extent of the surgical procedure area on the screen 330 with minimal movement of the camera 320 within the surgical cavity 210. For example, as depicted in fig. 1D, camera 320 may capture enough of the appropriate area of surgical cavity 210 so that screen 330 may depict the entire suturing method of crimping suturing device 100. It will be appreciated by those skilled in the art that this focusing of the camera 320 on a single area of the surgical cavity 210 is facilitated by providing a suturing device that provides a ready knot or a plurality of ready knots on a purpose-made thread as described herein, and thus eliminates the need for the healthcare provider to form his or her own knot in the suture thread in a conventional manner while performing the surgical procedure.

Referring now to fig. 2A-2C, an embodiment of the crimping suturing device 100 of the present invention features a needle 110 at one end of the crimping suturing device 100 and a crimped portion 150 having a thread at an end of the crimping suturing device 100 opposite the needle 110. The thread 120 may be any of several different lengths so that a healthcare provider or suturing professional may select a suitably sized crimping suturing device 100 as desired for a particular procedure. For example, it is known in the art that healthcare providers may use 36 inch (36 ") or 90 centimeter (cm) long suturing devices for one procedure, or shorter 6" or 15cm suturing devices for a different procedure. However, in all cases of the prior art, the suturing device must be several inches long to allow the healthcare provider sufficient space to thread and properly tie the sutures to ensure proper suture repair of the tissue during and at the completion of the surgical procedure. Thus, while the crimping suturing device 100 of the present invention may have wires 120 of different lengths, such that the exemplary gap 125 depicted in fig. 2A-2C may show several different lengths, the crimping suturing device 100 will almost always have wires 120 of a length shorter than the length of a corresponding suturing device without the set of crimps 150, which would require additional length to prepare and form a knot in the final step of suturing tissue.

The thread 120 may comprise any of a variety of materials that may be generally used as suture material. For example, the thread 120 may be a polypropylene suture of a non-absorbable surgical suture, such as PROLENE (PROLENE). Other examples of non-absorbable surgical sutures are polyester sutures (such as ETHIBOND) or nylon sutures (such as ETHILON or pronolon). Such non-absorbable sutures may be preferred during certain surgical procedures when a healthcare provider desires a stronger and more durable thread than other absorbable threads, such as during cardiovascular procedures. Alternatively, the thread 120 may be made of an absorbable thread such as, without limitation, a poligleron (poliglecaprone) suture, such as MONOCRYL (MONOCRYL), a polyglycolic acid (polyglactin) suture, such as VICRYL, or a polydioxanone (polydioxanone) suture, such as pds ii (pds ii). Such sutures may be preferred in certain surgical procedures when it is preferred that the suture ultimately disintegrate within the patient over a period of time. For example, certain absorbable threads may break down and be absorbed in a patient's body in as little as two weeks, or may last more than a year. However, such absorbable sutures are not preferred in surgical procedures where the suture is not only intended to repair but also to permanently join two tissues of the mass, such as for repair sutures for blood vessels, or for use in cardiovascular or neurological surgery. The crimping suturing device 100 of the present invention is not intended to be limited to one type of thread 120, but rather may be an absorbable or non-absorbable thread, such that a healthcare provider may select an appropriate type of crimping suturing device 100 based in part on the type of thread 120 that is unique in the crimping suturing device 100.

Additionally, the thread 120 may be of a woven or non-woven type. If the wire 120 is of the braided type, it may have a large number of strands (strand) interwoven together like a string. Such braided wires, which may be made of polyester, silk or other materials, will provide additional grip (grip) for the suture and may be stronger than non-braided wires. However, a non-woven wire may be preferred as the wire 120 of the crimping suture device 100 because it may be less susceptible to infection and may provide a more smooth surgical procedure in vivo. The wire 120 of the crimping suturing device 100 of the present invention may be of such a woven or non-woven variety such that a healthcare provider may select an appropriate type of crimping suturing device based in part on whether the wire 120 is of a woven or non-woven variety.

Crimping the needle 110 of the suturing device 100 may also be provided in various embodiments. Suture needles are generally of four types: a cutting needle (cutting needle), a reverse cutting needle (reverse cutting needle), a tapered needle (tapered needle), or a reverse tapered needle (reverse tapered needle). The needle 110 of the crimping suturing device can be cut, reverse cut, tapered, or reverse tapered such that a healthcare provider can select an appropriate type of crimping suturing device based in part on whether the needle 110 is a cut needle, a reverse cut needle, a tapered needle, or a reverse tapered needle.

Referring back to fig. 2A-2C, a feature of the crimping suturing device 100 is that the end section at the end opposite the needle 110 includes a set of crimped portions of wire 150, an angled semi-rigid portion of wire 140 immediately before the crimped portion of wire 150, and a stop mechanism 130 immediately before the semi-rigid portion of wire 140, such that the semi-rigid portion of wire 140 acts as an intermediate feature between the stop 130 and the crimped portion of wire 150. It can be appreciated that, given the surgical considerations discussed above, some of the wires may comprise a flexible type material, such as silk (silk). In this case, the semi-rigid portion 140 of the wire may have an additional coating of material with semi-rigid characteristics (such as, but not limited to, plastic or poliglen) to ensure that the semi-rigid portion 140 of the wire remains in a semi-rigid configuration.

As shown in fig. 2A, crimping suturing device 100 can have a stop mechanism 130, the stop mechanism 130 including an additional layer of material 130A directly overlying the suture and directly adjacent to the semi-rigid portion 140 of the angled line. When the crimping suturing device 100 is pulled through a tissue mass, the additional material layer 130A will act as a stop for the crimping suturing device because the suture thread area overlaid with the additional material layer 130A is correspondingly thicker than the main portion of the thread 120. Thus, it may not be pulled through tissue as easily as the thread 120, and would require significant additional effort to be pulled through the stapled tissue. Thus, when the needle 110 is pulled through a tissue mass, a major portion of the thread 120 up to the additional layer of material 130A will be pulled through the tissue mass, but the semi-rigid portion 140 of the thread and the crimped portion 150 of the thread will remain on the first side of the tissue due to the action of the additional layer of material 130A. As discussed above, it may be preferred that this additional layer of material 130A be located over the non-absorbable suture, as it may otherwise interfere with the absorbable suture, which is suitably broken down in vivo.

The stopper knot 130B depicted in fig. 2B functions in much the same manner as the additional layer of material 130A. Stop knot 130B is characterized by a semi-rigid portion 140 directly adjacent to the angled wire, such that semi-rigid portion 140 of the wire acts as an intermediate feature between stop knot 130B and crimped portion 150 of the wire. Stop knot 130B is configured such that when needle 110 and wire 120 are pulled through a tissue mass, stop knot 130B will stop wire 120 from advancing through the tissue mass. The stop knot 130B, semi-rigid portion of wire 140, and crimped portion of wire 150 will thus remain on the first side of the tissue in preparation for the formation of a suture knot, as will be discussed in more detail below. As discussed above, depending on the requirements of the absorbable suture chosen for the surgical procedure, it may be preferred that this stop knot 130B be located on the absorbable suture, as it will be formed of the same material as the absorbable suture and will therefore suitably disintegrate in vivo.

The barb construction 130C depicted in fig. 2C functions in much the same manner as the additional layer of material 130A and the stop knot 130B. The barb construction 130C is characterized by a semi-rigid portion 140 immediately adjacent the angled wire, such that the semi-rigid portion 140 of the wire acts as an intermediate feature between the barb construction 130C and the crimped portion 150 of the wire. The barb arrangement 130C is configured such that when the needle 110 and wire 120 are pulled through the tissue mass, the barb arrangement 130C will stop the advancement of the wire 120 through the tissue mass by grasping onto the tissue mass. The barb construction 130C, semi-rigid portion of wire 140, and crimped portion of wire 150 will thus remain on the first side of the tissue in preparation for the formation of a suture knot, as will be discussed in more detail below. As discussed above, depending on the requirements of the absorbable suture chosen for the surgical procedure, it may be preferred that this barb construction 130C be located on the absorbable suture, as it will be formed of the same material as the absorbable suture and will therefore suitably disintegrate in vivo.

It will be appreciated that the stop mechanism 130 can take a variety of forms and is not intended to be limited to the additional layer of material 130A, stop knot 130B, or barb configuration 130C discussed above. For example, the stop mechanism may be a portion of the thread configured with various serrated edges, knots or additional material that may stop the thread from advancing.

As shown in fig. 2A-2C, the coiled portion of wire 150 may include, but is not limited to, a first coiled portion 150A, a second coiled portion 150B, and a third coiled portion 150C. To suitably form the knot, the crimped portion of wire 150 should include at least a first crimp 150A and a second crimp 150B, and preferably also a third crimp 150C, as discussed below. However, it is to be understood that the crimped portion 150 of the wire may include additional crimps (e.g., a fourth crimp or a fifth crimp) to enable a larger or more secure knot to be formed, which may be preferred by healthcare providers in some procedures.

It can be further appreciated that the construction of the ready-to-use knot of the present invention comprising the angled semi-rigid portion of wire 140 and the crimped portion of wire 150 can be tailored such that the first combination of the semi-rigid portion of wire 140 and the crimped portion of wire 150 is pre-existing on the crimping suturing device 100 (as depicted in fig. 2A-2C), but automatically forms additional semi-rigid portions of wire and corresponding crimped portions of wire when the knot is formed from its previous combination, enabling the formation of multiple knots. The preferred embodiment of the present invention, which encompasses the construction of these additional ready-to-use knots, will be set forth below.

Referring now to fig. 3A and 3B, a method of suturing using the crimping suturing device 100 of the present invention is partially illustrated. As shown in fig. 3A, needle 110 may be inserted through first piece of tissue 220 from the inside to form a first hole 225 in first piece of tissue 220. Thereafter, the needle 110 is then inserted into the second tissue 230 such that a second aperture 235 is formed in the second tissue 230. Alternatively, as shown in FIG. 3B, depending on the location of the first and second pieces of

tissue

220, 230 relative to the healthcare provider, the needle 110 may be inserted through the first piece of tissue 220 from the outside to form a first aperture 225 in the first piece of tissue 220. Thereafter, the needle 110 is then inserted into the second tissue 230 such that a second aperture 235 is formed in the second tissue 230. However, the needle 110 of the crimping suturing device 100 thus connects the first piece of tissue with the second piece of tissue in a typical suturing fashion.

It will be appreciated that although fig. 3A and 3B depict two pieces of tissue in relative proximity to each other (which are close enough together that the needle 110 can be connected to both the first piece of tissue 220 and the second piece of tissue 230) the first piece of tissue 220 and the second piece of tissue 230 can be spaced apart from each other by a distance such that crimping the thread 120 of the suturing device can connect the first piece of tissue 220 and the second piece of tissue 230 together when the needle 110 is forming the first aperture 225 and the second aperture 235 at the beginning of suturing.

Referring now to FIG. 4, a method of suturing using the crimping suturing device 100 of the present invention is illustrated in continuing part in conjunction with the previous FIGS. 3A and 3B. As shown, upon penetration of the first and second pieces of

tissue

220, 230 by the needle 110 as described above (whether from the interior of the tissue or from the exterior of the tissue as described above), the suturing method will further comprise pulling the needle 110 with a first forceps 340A of the pair of forceps. The second pair of forceps 340B will simultaneously hold the opposite ends of the wire at a distance that allows the stopping mechanism 130 of the crimping suturing device 100 to be utilized. Thus, as previously shown in fig. 3A and 3B, any gaps 240 between the first and second pieces of

tissue

220, 230 are forced closer together at the connection region 250. It can be appreciated that when the stop mechanism 130 of crimping suturing device 100 is adjacent to the first aperture 225 in the first piece of tissue 220, the wire 120 will no longer be pulled through the first aperture 225 in the first piece of tissue 220. Instead, the first piece of tissue 220 will be pulled closer to the second piece of tissue 230, minimizing the gap 240 between the first piece of tissue 220 and the second piece of tissue 230 to form the connection region 250. In addition, any ready knot configuration of crimping suturing device 100 (such as the illustrated angled wire semi-rigid portion 140 and wire crimped portion 150) will not be pulled through first hole 225 in first piece of tissue 220, but will instead remain intact outside of first piece of tissue 220.

When the first piece of tissue 220 and the second piece of tissue 230 are drawn together, as shown in fig. 4 and described above, the angled semi-rigid portion 140 remains on the exterior of the first piece of tissue 220. Thus, the straight portion 140 of the wire provides space for the curled portion 150 of the wire to be more easily accessible to the healthcare provider when forming the desired knot.

As shown in fig. 3A, 3B and 4, a method of suturing using the crimping suturing device 100 of the present invention includes a healthcare provider directing a needle 110 from a second piece of tissue 230 through a crimped portion 150 of thread located on the exterior of the first piece of tissue 220. The healthcare provider first guides the needle 110 through the first crimp 150A (the crimp furthest from the semi-rigid portion of the thread 140), and then guides the needle 110 through the second crimp 150B, the third crimp 150C, and any additional crimps that may be in the crimped portion of the thread 150.

Referring now to FIG. 5, a method of suturing using the crimping suturing device 100 of the present invention is illustrated in continuation. Here, the first knot 155 in the crimping suturing device 100 is formed when the healthcare provider pulls the needle 110 using a first forceps 340A of the pair of forceps while pulling the opposite end of the thread 120 with a second forceps 340B of the pair of forceps after the needle 110 is guided through the crimped portion 150 of the thread (as depicted in fig. 4 and described above). Simultaneously with crimping the knot formed in the suturing device 100, pulling the needle 110 and correspondingly the wire 120 with the pair of forceps 340 will also effectively close the gap 240 between the first and second pieces of

tissue

220, 230. Thus, the first and second pieces of

tissue

220, 230 are drawn adjacent to one another to form the desired connection region 250 as required by the procedure, and thus, the first knot 155 holds the suture in place.

Referring now to FIG. 6, a method of suturing using the crimping suturing device 100 of the present invention is further illustrated. Here, upon forming the first knot 155, the healthcare provider may release the second forceps 340B of the pair of forceps to enable the wire 120 to automatically form a second ready-made knot comprised of the second angled wire semi-rigid portion 160 and the corresponding wire second curled portion 170 located outside the first piece of tissue 220. This additional ready knot configuration enables additional knots to be formed in the crimping suturing device 100 of the present invention in much the same manner as the first knot 155 is formed. Here, the second angled semi-rigid portion 160 provides space for the crimped portion 170 of the wire to be readily accessible to the healthcare provider when forming the desired knot. Thus, the healthcare provider may use the first forceps 340A of the pair of forceps to guide the needle 110 through the second curled portion 170 of the thread. Specifically, the healthcare provider first guides the needle 110 through the first crimp 170A (the crimp furthest from the semi-rigid portion 160 of the second angled wire), and then guides the needle 110 through the second crimp 170B, the third crimp 170C, and any additional crimps that may be in the second crimp 170 of the wire.

Thereafter, the healthcare provider may form the second knot 175 as shown in fig. 7 by pulling the needle 110 using the first forceps 340A of the pair of forceps while also pulling the opposite end of the thread 120 with the second forceps 340B of the pair of forceps, as depicted in fig. 5, after the needle 110 is guided through the second curled portion 170 of the thread. Forming this second knot 175 alongside the first knot 155 will create additional friction in the suture to further secure the connection region 250 between the first and second pieces of tissue 220, 230 (which may be required by the surgical procedure), and thus, the first and

second knots

155, 175 hold the suture securely in place.

Thus, if satisfactory results are achieved for the formed suture thread, the healthcare provider may cut off excess thread of the crimp suture device 100 as well as the needle. Otherwise, as shown in fig. 8, the healthcare provider may desire to create more friction between the first knot 155 and the second knot 175 of the suture by: another knot is formed in the crimping suturing device 100 of the present invention by again releasing the second forceps 340B of the pair of forceps so that the thread 120 is able to form a third ready made knot comprised of the third angled semi-rigid portion 180 of the thread and the corresponding third crimped portion 190 of the thread that is outside the first piece of tissue 220. This additional ready knot enables another knot to be formed in crimping suturing device 100 in the same manner as second knot 175.

It will be appreciated that, given that the healthcare provider is not required to form knots in the suture by other means, he can effectively suture the appropriate tissue with only one hand using the crimping suturing device 100 of the present invention. Thus, if the healthcare provider realizes that the knot to be formed is not in the proper location at the time of suturing, the healthcare provider can easily adjust the position of the suture and knot to be formed within the surgical cavity. This adjustment is facilitated by the use of crimping suturing device 100 and its ready knot, in part because the healthcare provider is able to control the movement of both crimping suturing device 100 and

tissue

220 or 230 with only one hand.

It will also be appreciated that crimping the stapling apparatus 100 reduces the instrumentation used and crowding that occurs during laparoscopic surgery using currently available stapling apparatus in the art, since the crimping stapling apparatus 100 is operated with only one hand to effectively staple suitable tissue. Furthermore, as discussed above and depicted in fig. 1C and 1D, crimping suturing device 100 also concentrates the surgical field of the surgical procedure on the area of

crimped portions

150, 160, and/or 170 having wires, thereby allowing a healthcare provider to more effectively utilize his or her available viewing area (which is typically limited during laparoscopic procedures).

Many changes and modifications may be made to the invention without departing from the spirit thereof. Accordingly, the applicant's right to the invention is limited only by the scope of the appended claims.

Claims

1. A suturing device, comprising:

(i) a needle; and

(ii) a wire operably attached to the needle, the wire further comprising:

(a) a crimped portion of the wire comprising at least a first crimp, a second crimp, and a third crimp, and wherein the crimps of the crimped portion of the wire have a helical configuration;

(b) a semi-rigid portion of the wire immediately preceding the crimped portion of the wire;

(c) a stop mechanism immediately preceding the semi-rigid portion of the wire, wherein the stop mechanism is angled with respect to the semi-rigid portion of the wire; and

(d) a middle portion of the thread intermediate the needle and the stop mechanism;

wherein the needle is a cutting needle, a reverse cutting needle, a tapered needle, or a reverse tapered needle;

wherein the thread is a non-absorbable suture thread or an absorbable suture thread;

wherein the coiled portion of the wire maintains the helical configuration until the coiled portion of the wire transitions into a knot in the wire; and is

Wherein the wire is capable of forming an additional curled portion of the wire and a corresponding semi-rigid portion of the wire when a knot is formed in the wire.

2. The suturing device of claim 1, wherein the stop mechanism comprises an additional layer of material directly overlying a portion of the thread immediately preceding the semi-rigid portion of the thread.

3. The suturing device of claim 1, wherein the stop mechanism includes a stop knot immediately preceding the semi-rigid portion of the thread.

4. The suturing device of claim 1, wherein the stop mechanism comprises at least one barb immediately preceding the semi-rigid portion of the thread.

5. The suturing device of claim 2, wherein the thread is a braided suture thread.

6. The suturing device of claim 2, wherein the thread is a non-woven suture thread.

7. The suturing device of claim 3, wherein the thread is a braided suture thread.

8. The suturing device of claim 3, wherein the thread is a non-woven suture thread.

9. The suturing device of claim 4, wherein the thread is a braided suture thread.

10. The suturing device of claim 4, wherein the thread is a non-woven suture thread.

11. A method of suturing, comprising:

(i) there is provided a suturing device comprising:

(a) a needle; and

(b) a wire operably attached to the needle, the wire further comprising:

(1) a crimped portion of the wire comprising at least a first crimp, a second crimp, and a third crimp, wherein the crimps of the crimped portion of the wire have a helical configuration;

(2) a semi-rigid portion of the wire immediately preceding the crimped portion of the wire;

(3) a stop mechanism immediately preceding the semi-rigid portion of the wire, wherein the stop mechanism is angled with respect to the semi-rigid portion of the wire; and

(4) a middle portion of the thread intermediate the needle and the stop mechanism;

Wherein the wire is capable of forming an additional curled portion of the wire and a corresponding semi-rigid portion of the wire when forming a knot;

(ii) inserting the needle through a first piece of tissue to form a first hole in the first piece of tissue;

(iii) pulling the needle a distance away from the first piece of tissue such that the middle portion of the thread is pulled through the first hole of the first piece of tissue and inserting the needle through a second piece of tissue to form a second hole in the second piece of tissue;

(iv) pulling the needle a distance away from the second tissue such that the middle portion of the thread is pulled through the second aperture of the second tissue until the stop mechanism is adjacent the first aperture of the first tissue;

(v) inserting the needle through the crimped portion of the thread and pulling the needle a distance away from the crimped portion of the thread such that the crimped portion of the thread forms a first knot in the thread; and

(vi) in forming the first knot, the needle and the thread are released to enable the thread to form the additional curled portion of the thread and the corresponding semi-rigid portion of the thread, the needle is inserted through the additional curled portion of the thread, and the needle is pulled away from the additional curled portion of the thread by a distance such that the additional curled portion of the thread forms an additional knot alongside the first knot in the thread.

12. The suturing method of claim 11, wherein the stop mechanism comprises an additional layer of material directly overlying a portion of the thread immediately preceding the semi-rigid portion of the thread.

13. The suturing method of claim 11, wherein the stop mechanism comprises a stop knot immediately preceding the semi-rigid portion of the thread.

14. The suturing method of claim 11, wherein the stop mechanism comprises at least one barb immediately preceding the semi-rigid portion of the thread.

15. The suturing method of claim 12, wherein the thread is a braided suture thread.

16. The suturing method of claim 12, wherein the thread is a non-woven suture thread.

17. The suturing method of claim 13, wherein the thread is a braided suture thread.

18. The suturing method of claim 13, wherein the thread is a non-woven suture thread.

19. The suturing method of claim 14, wherein the thread is a braided suture thread.

20. The suturing method of claim 14, wherein the thread is a non-woven suture thread.