JP2011509784A - Suture instrument and suture system - Google Patents

Abstract

  The needle storage / disposal cartridge is loaded with a needle receiver, a suture thread, and a needle. By inserting the inside of the cartridge into the forceps arm, the needle holder can be attached to the arm of the forceps and similarly can be removed after use. Forceps can be conventionally used to grasp and hold the needle during suturing. A number of alternative suturing forceps and needle holders are disclosed.

Description

  This application is based on US Provisional Application No. 61 / 023,401, filed January 24, 2008, and International Application No. PCT / EP2008 / 053584, filed March 26, 2008 (currently abandoned). All of which are hereby incorporated by reference in their entirety.

  The present invention relates to surgical instruments and systems that are used for tissue suturing while reducing the likelihood of needle perforation accidents before, during and after a suturing procedure.

  Standard suturing instruments and suturing techniques present a significant risk to both the patient and the surgeon due to possible glove piercing accidents where the suturing needle penetrates the surgeon's gloves. Such needlestick accidents include, but are not limited to, pathogenic organisms such as hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV) transmitted from patients to field workers. May be forgiven.

  Conversely, perforation accidents can cause the collapse of the sterile barrier between the field worker and the patient, which increases the risk of injury to the infected patient. In the context of surgery, accidental penetration of a part of a patient's organism during suturing is sometimes referred to as a perforation event. In the following, references to needle stick accidents and drilling accidents will be used interchangeably.

  One approach that helps to circumvent this problem involves the use of surgical forceps of the same type as those described in US 2003/0045833. The surgical forceps described in the application have a flexible material on the outer surface of the forceps arm near the distal end that can be used to handle the surgical needle during suturing to attempt to prevent needle drilling accidents. Have.

  Among the disadvantages of these and other surgical forceps are that tissue can be damaged during suturing using a surgical needle and a suture attached to the surgical needle. This is a particular disadvantage associated with delicate tissue that is difficult to pass through a surgical needle without causing tissue damage. The tip of the surgical needle first pushes the tissue forward and advances in order to substantially incise the tissue, causing damage to the tissue. Further, in the surgical forceps described in the above application, placing the flexible material on the outer surface of the arm at a location remote from the distal end of the arm requires the tissue to be released to accept the needle. To do. Instead, the instrument may be pushed further into the wound, resulting in an increased likelihood of damaging the tissue and / or an already sutured seam.

  Other approaches to this problem are described in WO 2005/094698 (International Application No. PCT / EP2005 / 003476), U.S. Patent Application No. 11 / 025,727 and U.S. Patent Application No. 10/599, No. 503, the entire contents of which are incorporated herein by reference.

  Another scenario where a needle perforation accident can occur is during minimally invasive surgery where the exposed sharp tip of the needle can inadvertently puncture or cut tissue in the patient.

  Thus, for suturing forceps and suturing systems that minimize the risk of glove perforation accidents and other types of needle perforation accidents, and preferably tissue damage before, during and after suturing procedures. The request still remains.

  The present invention provides a surgical instrument and a surgical system that can avoid a needle drilling accident, reduce tissue damage during suturing, and perform suturing more easily. Is directed.

  The following description is made by way of example and is not intended to limit the invention as recited in the appended claims.

  For purposes of this application, the terms “needle holder”, “NR” or “bullet” apply to the portion of the suture instrument of the present invention that receives and attaches a surgical needle. In a preferred embodiment, a needle receiver (NR) is placed at the distal end of the differently structured suture forceps described herein.

  In one embodiment, the present invention comprises at least first and second arms connected at the base end and capable of being biased, for example by spring means, in the open position, said first and second arms being said first and second arms. And a space that can be reduced and increased between the second arm and the present invention, in combination with a cartridge for storage and / or disposal of NR, to receive and attach a needle NR is further provided. The NR is preferably positioned at the distal end of the forceps arm. The term “open” in connection with the present invention applies to the position where the distal ends of the two arms are separated. The term “closed” applies to a position where the distal ends of the two arms are in close proximity or contact.

  In certain embodiments, the NR may be removable from the suture instrument when the NR can be disposable. In this regard, it will be understood that reference to NR may also include a mounting portion that allows coupling of the NR to a surgical instrument such as a forceps or needle holder.

  In one embodiment, the NR is disposed on the outer surface of the arm end at the distal end of the forceps arm. In another embodiment, the NR is located on the inner surface of the end of the arm at the distal end of the forceps arm. In other embodiments, the NR is located on either side of the end of the arm at the distal end of the forceps arm. In yet another embodiment, the NR is integrated into the distal end of the forceps arm. In yet another embodiment, the NR may be located at the distal end of the arm, either on the inner surface, the outer surface, or the side surface of the end of the arm, and extends beyond the distal end of the arm.

  In other embodiments, the NR may form part of the tissue grasping surface of the suture instrument. In these embodiments, the NR is positioned to simultaneously support the tissue to be pierced with the surgical needle and after receiving the needle so that the needle can be manipulated with the instrument. It is possible to attach. This allows the surgical needle to be safely manipulated during suturing without touching the needle with the hand, thus reducing the possibility of a needle drilling accident. In these embodiments, the NR may be located anywhere on the distal end of the forceps arm that allows the NR to simultaneously grasp tissue and receive and attach a surgical needle, but far from the forceps arm. It is suitably positioned on at least one of the inner surface and the side surface of the end portion of the arm at the rear end.

  In other embodiments, the NR does not form part of the tissue grasping surface of the suturing instrument. However, the NR is positioned so that the forceps arm can receive and attach the needle while grasping the tissue. In these embodiments, the NR may be disposed on the outer surface of the end of the arm at the distal end of the forceps arm.

  When suturing tissue with a surgical needle, the forceps and suturing system of the present invention completes suturing, primarily for an additional suturing step, immediately after the surgical needle tip has pierced the tissue. For the safe and efficient disposal of the sharp needle and NR until and afterwards, the use of a needle storage and disposal cartridge allows the surgical needle tip to enter the NR which is held until removal by the surgeon. It makes it possible to control the suturing procedure as it is possible. This allows the surgical needle to be safely manipulated during suturing without touching the needle by hand, which allows the forceps and needle to be safely handed between users by protecting the tip of the needle. And that allows safe and easy disposal of the NR and needle, thus reducing the possibility of needle drilling accidents throughout all steps of the suturing procedure. Such also prevents needle drilling accidents that can occur during minimally invasive surgery and when manipulating the needle within the patient when the needle is removed from the patient. The term “needle mounting material” as referred to herein means a material capable of receiving a surgical needle and removably mounting or holding the surgical needle. For example, the needle attachment material can be, but is not limited to, a soft plastic material or a synthetic rubber material.

  The present invention will be further described herein by way of illustrative embodiments that do not limit the scope of the appended claims and by reference to the following drawings.

It is a figure which shows the needle accommodation and disposal cartridge (left division) loaded with NR (or bullet-like body), and insertion of the forceps arm into the cartridge (right division). FIG. 5 shows a suturing system component comprising a needle storage / disposal cartridge, a mounting or attachment mechanism, eg, a rail for storing the cartridge, an NR, a needle holder, and a suture forceps. It is a figure which shows the continuous step which loads NR into a needle | hook storage / waste cartridge. The NR in the needle storage / disposal cartridge is transferred to the distal end of the forceps arm (upper compartment), and the forceps arm is inserted into the chamber-type NR embodiment optionally attached with a needle with suture (lower). (Compartment) It is a figure which shows a continuous step. FIG. 5 shows a cartridge suitable for both NR release and disposal of NR with needle and optional suture. FIG. 4 shows an embodiment of a chamber-type NR that grips an inserted needle for safe storage and through which the needle passes while the tip of the needle is fully protected. It is a bottom view (upper left section), a top view (upper right section), and a side view (lower section, attached to a forceps arm) showing the sandwich type NR. FIG. 5 is a side view of an embodiment of a sandwich NR with a needle attached to a forceps arm and inserted into a hole in the top of the NR. It is a figure which shows the NR-lift part type forceps which concern on this invention. FIG. 6 shows an NR-lift forceps in a continuous stage for receiving and attaching a surgical needle. FIG. 6 shows further embodiments of the NR-lift forceps. It is explanatory drawing of the fork-shaped tip type forceps which concerns on this invention. It is a figure which shows another forceps embodiment of this invention. It is explanatory drawing of further several embodiment of the forceps of this invention. It is explanatory drawing of further several embodiment of the forceps of this invention. FIG. 6 is an illustration of further embodiments of the NR-bulge. FIG. 6 is an illustration of a “micro” forceps suitable for cardiovascular surgery with a relatively small NR provided on a removable holder.

  In one aspect, the present invention provides a cartridge for safe storage and disposal of needles and NRs. The cartridge can contain NR and may also contain a needle or needle with suture. The NR can be the NR of any of the embodiments described herein. The cartridge can be mounted on, for example, a rail in the operating room or other suitable mounting surface. The cartridge includes a housing having an opening through which a user can insert forceps. Once the forceps are inserted into the cartridge, the NR is attached to the forceps. In one embodiment, rotation of the forceps within the cartridge by the user will attach the NR to the forceps. When the forceps are withdrawn, the NR is accurately positioned on the forceps and the sharp tip of the needle is inserted into the NR so that the forceps can be safely delivered from, for example, a nurse to the surgeon. Preferably, the NR can be removed from the cartridge only upon correct forceps insertion and correct forceps connection.

  After use of the NR, a forceps with a dirty NR suture is inserted into the cartridge. By rotating the forceps, the NR is pulled away from the forceps and the NR and dirty suture remain in the cartridge. Preferably, the cartridge comprises means for indicating to the user that the cartridge is “loaded”, for example by a colored indicator or by the housing of the cartridge being transparent. Specific examples of the needle storage and disposal cartridge are shown in FIGS. The housing is preferably a rigid housing, such as a hard plastic, and substantially encloses the NR in all respects. In this way, access to the NR, needle and suture in the housing is prevented until the NR, needle and suture are removed in the correct manner through the opening. It will thus be appreciated that in a preferred embodiment, insertion of the user's finger through the opening and into the interior of the cartridge is prevented. Access to the interior of the cartridge housing is also prevented by the presence of the NR or its presence.

  In one embodiment, a cartridge is provided that is configured to accommodate two or more NRs. Such a cartridge is particularly advantageous for combination with two-armed suturing (i.e., needles are placed at both ends of the suture) and / or with relatively small needles. For example, cardiovascular sutures are usually two arms and the needles attached to each end of the suture are relatively small. Relatively small needles may be used in combination with a relatively small NR, so that the cartridge may be configured to hold a number of these relatively small NRs.

  The cartridge and NR may be integrally molded as one part. For example, a cartridge having a hard plastic housing may be integrally molded simultaneously with NR. The NR may comprise a soft needle attachment material, such as soft plastic, that can be partially covered by a hard plastic support material. The NR should be easily separated from the cartridge once attached to the forceps arm and should remain attached to the forceps arm when the user pulls the forceps out of the cartridge. Alternatively, the cartridge may be manufactured separately from the NR.

  In various embodiments of the present invention, the cartridge is used in combination with forceps, the forceps comprising a first arm and a second arm connected at a proximal end, wherein the first arm and the second arm are: A space that can be reduced or increased is formed between the first arm and the second arm, and the forceps are disclosed in US patent application Ser. No. 11 / 025,727 and US patent application Ser. It further comprises any of the needle guards (NR) of the embodiments described in the 599,503 specification. In such embodiments, the NR is attached to the inner surface, the outer surface, or the side surface of the arm at the distal end of the forceps arm.

  In certain embodiments, the cartridge is used in combination with a forceps with an NR that can be penetrated with a surgical needle. In a preferred embodiment, the NR is composed of an elastomeric material such as synthetic rubber. In a related embodiment, the NR is composed of an elastomeric material having a hollow core, the NR being cross-sectionally configured with the first layer, the space, and the NR being shaped lock by the form lock. And a second layer for attaching the needle. In another related embodiment, the NR consists of a wire network. In yet another related embodiment, the NR comprises a soft plastic material.

  In other embodiments, the cartridge is used in combination with a forceps comprising an NR constructed from a magnetic material.

  In other embodiments, the cartridge is used in combination with a forceps comprising an NR constructed from an adhesive material.

  In other embodiments, the cartridge is used in combination with a forceps comprising an NR with a guiding gripping mechanism selected from a plunger and a clamp. Some suturing procedures require the use of relatively large needles to pierce hard tissue such as fascia and other tissues, and to grasp the needle to pull the suture through the tissue. To do. An NR suitable for grasping a relatively large needle must exert sufficient pressure on the needle to maintain the grasp of the needle while pulling the suture through hard tissue. Accordingly, an NR suitable for gripping relatively large needles preferably includes a guide gripping mechanism such as a plunger mechanism or a clamp to accept and removably attach a large surgical needle. For example, there is no friction in the NR so that when the distal ends of the arms are separated, a plunger mechanism that is dependent on the distance between the distal ends of the arms is activated to push a portion of the needle into the opening. The NR may be configured to have an opening that allows a surgical needle to be inserted. The plunger pressing force acts to catch the needle, resulting in gripping the needle, thereby attaching the needle to the NR. Conversely, when the distal ends of the arms are in close proximity, the plunger mechanism removes pressure on the needle in response to retracting the plunger and the needle is released. Alternatively, the plunger mechanism may be independent of the distance between the distal ends of the forceps and may be moved manually by a surgeon, nurse or specialist.

  In other embodiments, the cartridge is used in combination with a forceps comprising an NR comprising a needle-receiving attachment layer (eg, soft plastic) that is at least partially surrounded by a needle-impervious layer (eg, hard plastic). The needle receiving attachment layer is directly accessible to the surgical needle through a break in the needle impenetrable layer. The NR may comprise means at its proximal end for removably attaching to the end of the forceps arm. The tip of the needle may be inserted so that the needle is parallel to the longitudinal axis of the NR, or may be inserted at an angle (ie, inclined) with respect to the longitudinal axis of the NR. Thus, the sharp needle tip will be covered during handling, disposal and even possible storage. Examples of this embodiment include a chamber type NR shown in FIGS. 6 and 15 and a sandwich type NR shown in FIGS. 7 and 8.

  In yet another embodiment, the cartridge is used in combination with a forceps comprising a first arm and a second arm, the first arm penetrating with a surgical needle into the inner surface of the end of the arm at the distal end of the arm. An NR suitable for being provided, the NR further comprising a groove along a longitudinal axis of the forceps arm, the second forceps arm being a raised portion on the inner surface of the arm at the distal end of the arm The raised portion is positioned so as to fit in the groove when the forceps is in the closed position. When the forceps are in the closed position, the raised portion applies a force to the needle inserted into the NR at the distal end of the first forceps arm, catches the needle against the inner surface of the first forceps arm, and Increase gripping force. The needle can be released by opening the forceps and pulling the needle in the opposite direction. Since the force on the needle can be adjusted by hand, gripping of such a needle can be guided. The needle attachment portion and / or the raised portion of the NR may be disposable or may form a permanent part of the forceps. Examples of this embodiment are shown in FIGS.

  In another embodiment, the present invention provides a forceps suitable for gripping a large surgical needle, the forceps comprising: (A) a first arm and a second arm connected at a proximal end; (B) a pair of claws extending substantially perpendicular to the longitudinal axis of the forceps at the distal end of each forceps arm; and (C) first needle guiding means adjacent to the pair of claws on the second arm. And (D) optionally, second needle guide means proximate to the first needle guide means of the second arm, and the pair of claws of the second arm, Opposite the pair of claws of the first arm and are distal to the pair of claws of the first arm when the forceps are in the closed position. The purpose of this device is to hold a large needle between the claws of the first and second arms and hold the large needle tightly without exposing the tip of the needle (and without protruding the needle) It is to be. The locking means may comprise a fastener that does not act on the forceps until the forceps are tightly closed and grasped, the fasteners locking the forceps in the closed position. The forceps may be disposable or reusable. Such an embodiment may be referred to as a “fork-tip forceps” embodiment. An example of this embodiment is shown in FIG.

  In another embodiment, the present invention provides a method for preventing needle stick accidents or needle penetration accidents during a suturing procedure, the method comprising (A) inserting a forceps arm into a needle disposal and storage cartridge. The cartridge includes a needle and a suture, thereby loading the forceps with NR, the needle and the suture, and (B) removing the forceps arm from the cartridge; And (D) removing the forceps from the cartridge by later reinserting the forceps arm into the cartridge, thereby discarding the NR, needle and suture. Preferably, the cartridge is in the cartridge state (ie, whether the cartridge is loaded with new NR, needle, suture or whether the cartridge contains used NR, needle, suture). Or a means for displaying. Thus, unwrap the suture, place the needle by hand in the needle holder, hand the needle and needle holder to the surgeon, and discard the unprotected, dirty sharp needled instrument. Instead, the method allows the suturing procedure to be performed without the need for direct human contact with a sharp surgical needle, thus reducing injury due to needle stick during surgery, or , Preferably excluded.

  In another embodiment, the present invention provides a suturing system, wherein the suturing system is (A) at least one cartridge, (B) at least one NR, and (C) said cartridge. A mounting mechanism such as a rail or other mounting surface for holding the clamp, (D) forceps, and (E) a clamp.

  In yet another embodiment, the present invention provides a forceps suitable for gripping a large needle comprising a first arm and a second arm. A first NR is disposed at the distal end of at least one arm of the composite forceps, and a second NR is disposed proximate to the first NR. The first NR is integrated into at least one arm, and the first NR includes an opening disposed at a distal end of the arm through which a needle can be inserted and a needle attachment material that grips the needle after insertion. The purpose of the first NR is to hold the needle as the user ties a knot to the suture, and to cover the tip of the needle during forceps transport. The second NR may be any of the NRs of the embodiments described herein. The composite forceps may be disposable or reusable. The second NR can be used, for example, during successive stitches. Such an embodiment may be referred to as a “composite forceps”. An illustration of this embodiment is provided in FIG.

  A forceps comprising an NR having any combination of features of any of the previously described embodiments of NR can also be used in combination with the cartridge of the present invention and as part of the suturing system of the present invention. It will be understood that it can be used. An illustration of a forceps comprising an NR having features of both the NR ridge embodiment and the sandwich NR embodiment is provided in FIGS. 14A and 14B.

  The same reference numerals used in the drawings apply to similar parts.

  Referring to FIG. 1, reference numeral 1 denotes a needle storage / disposal cartridge according to the present invention. The needle storage / disposal cartridge 1 includes an NR 2 and a housing 3 having an opening 4 that can guide a forceps arm. FIG. 1 further shows that the waste cartridge comprises means 5 for indicating to the user that the cartridge is “loaded” with NR and optional suture. The NR may be comprised of any needle receiving and retaining material suitable for being penetrated with a surgical needle, or the NR is releasably retained until removed by a surgeon as further described below. As long as it does, you may provide a guidance grasping mechanism.

  FIG. 2 shows a suturing system including a plurality of needle storage / disposal cartridges 1, cartridge holding rails 6, suturing forceps 7, a needle holder 8, and NR 2.

  FIG. 3 illustrates the loading of a new NR 2 into the cartridge 1. Means 5 to indicate to the user that the cartridge has been loaded is provided by a color indicator, which is green when the cartridge is loaded and red when the cartridge is not loaded.

  FIG. 4 (upper compartment) describes an embodiment of a cartridge that allows the user to attach or remove the disposable NR from the reusable forceps. The cartridge is composed of two joined parts, thus forming a small box. When the user inserts the forceps arm 9 into the loaded cartridge 1 through the first opening 4 and then rotates the forceps clockwise until the forceps is substantially parallel to the cartridge, the NR 2 moves the forceps arm 9 at that position. Attached (ie, snapped). Thereafter, when the user pulls out the forceps (with NR) from the cartridge through the second opening 4 ′, the forceps can be used. At the end of the surgery, the dirty forceps with NR is inserted into the box through the second opening 4 'and rotated counterclockwise. The NR remains horizontal to the cartridge (eg, via snap fingers) and forceps (without NR) can be removed from the cartridge via the first opening 4.

  FIG. 4 (lower compartment) further illustrates cartridge 1 loaded with NR2 and suture 10 attached to NR2. The forceps arm 9 is inserted into the cartridge, and the NR2 is attached to the forceps arm 9.

  FIG. 5 illustrates a cartridge 1 suitable for both releasing NR2 and optional suture 10 and discarding NR2 with suture 10. FIG. Opening 4 along with a needle attached to NR2 guides NR2 into cartridge 1 for safe disposal.

  FIG. 6 illustrates an embodiment of a chamber type NR. In this embodiment, the NR preferably comprises a housing 11 made of hard plastic. The housing includes a chamber 12 filled with a soft needle mounting material (eg, soft plastic). The chamber 12 is accessible through a hole 13 in the housing 11. The distal end of the suture needle 14 is inserted into the housing 11 through the hole 13 and penetrates the soft material in the chamber 12. The housing further comprises a snap finger 15 for attaching the NR to the distal end of the forceps arm. Although it is considered that the opening can face in any direction, when the snap fingers 15 are attached to the forceps arm, the hole 13 preferably faces the inner surface of the other forceps arm. The sharp needle tip will be covered during handling, disposal, and potential further storage.

  FIG. 7 depicts an embodiment of a disposable sandwich NR. In this embodiment, the NR includes a housing 11 that includes a snap finger 15 that extends along the longitudinal axis of the housing at a lower portion 16 of the housing. The distal portion of the housing comprises a needle attachment material 17 sandwiched between the upper and lower surfaces 18 and 19 of the housing. The distal portion of the housing is arranged to provide uninterrupted access to the needle mounting material 17 at the distal end of the housing along the side of the distal portion of the housing, and the needle mounting The needle attachment material 17 is also arranged so as to contact the forceps arm when the material 17 is attached to the forceps. The needle was inserted into the needle attachment material and was due to the material specifications of the material and the fact that the material was pressed between the forceps arm and the inner surface of the housing when the NR was attached to the forceps arm. Held in place. A bottom view (upper left section), a top view (upper right section), and a side view (lower section) are shown. The side view depicts a housing with needle attachment material (lower left compartment) and a housing without needle attachment material (lower right compartment).

  FIG. 8 depicts an embodiment of a disposable sandwich NR (shown attached to the forceps arm 10), which includes a hole 21 in the upper portion 22 of the housing, the hole 21 being The needle 40 inserted through the hole is arranged to allow the needle mounting material 17 to penetrate.

  9 and 10 illustrate an embodiment of a raised NR. In this embodiment, a needle attachment material 17 (eg, soft plastic) is disposed on the inner surface of the arm at the distal end of the first forceps arm 20. The needle attachment material 17 includes a groove or slot 23 along the longitudinal axis of the forceps arm. In other words, the needle mounting material 17 is locally composed of two thin walls. The second forceps arm 24 terminates at the distal end with a pair of claws 25 that are substantially perpendicular and inward from the longitudinal axis of the forceps. On the inner distal surface of the second forceps arm 24, there is disposed a ridge 26 (formed from a hard material such as metal or hard plastic) that is close to the nail and is close to the nail. When the forceps are in the closed position, the forceps are positioned so as to fit in the slot 23 of the first forceps arm 20. The needle 14 is inserted through both walls of the needle attachment material 17 or through one wall and intersects the slot. The forceps are then closed and the raised portion 26 contacts the needle 14 and presses the raised portion 26 toward the inner surface of the first forceps arm, thus increasing the gripping force of the needle. Since the force on the needle is adjustable by hand, this way of gripping the needle is inducible.

  FIG. 11 is a side view of an additional embodiment of forceps. The explanatory diagram explains that the position of the raised portion 26 may change on the inner surface of the second forceps arm 24. Accordingly, the position of the slot 23 (formed from a soft needle mounting material) on the first arm 20 may change. The illustration also explains that the position of the needle inserted into the slot 23 on the first arm 20 may change. For example, the needle 14 may be inserted into the outer surface of the first arm (upper left section, lower left section and lower right section), or may be inserted into the inner surface of the first arm (upper right section). Alternatively, the needle 14 may be inserted at the distal end of the first arm. Regardless of the insertion position of the needle, in each embodiment, the inserted needle is in the slot on the first arm. When the forceps are closed, the slot is occupied by the ridges and presses and grabs the needle inserted into the slot. Importantly, in each embodiment (including embodiments where the needle insertion point is located outside the forceps arm), the needle may be inserted into the forceps arm while the forceps is gripping tissue. Good. The soft needle attachment material comprising the slot may be disposable and may comprise means (eg snap fingers) for removably attaching to the forceps arm. The forceps arm of each illustrated embodiment comprises a series of meshing teeth on the inner distal surface (ie, tissue gripping surface) of the arm.

  FIG. 12 illustrates a forked tip surgical forceps suitable for holding a large surgical needle and holding the needle tightly without exposing the tip of the needle. The forceps includes a first arm 20 and a second arm 24, each of the first arm 20 and the second arm 24 being V-shaped established with two claws 27 across the arm (at the distal end). The claw 27 extends inward so that the claw of the first arm faces the claw of the second arm. The claw 27 on the second arm 24 is more distal to the claw 27 on the first arm 20 so that the claw 27 on the first arm 20 is adjacent to the claw 27 on the second arm 24 when the forceps are closed. is there. The second arm 24 of the forceps further includes needle guide means 28 disposed proximate to the tip to maintain the surgical needle parallel to the forceps. The means may comprise a grooved ridge or may comprise two claws resembling claws at the tip of the arm. The large needle 14 (eg barely protruding from the tissue) is placed between the nail 27 on the first arm 20 and the nail 27 on the second arm 24, and the forceps are tightly closed. The needle is clamped between the claws 27 of each arm (like a wire in a wire cutter) and rides on the grooved ridge 28, maintaining the needle in a position parallel to the forceps. The forceps may further comprise locking means 29 for maintaining the forceps arm in a fixed position. In one embodiment, the locking means comprises a fastener. The fastener does not act until the forceps are closed and pushed firmly into place, reversibly closing the forceps back to the fixed position. The forceps may be reusable or disposable.

  In a related embodiment, the second forceps arm comprises second needle guide means disposed proximate to the first needle guide means. Preferably, the second needle guiding means is constructed from a hollow metal shape or a shape occupied by a flexible material into which the needle can be guided. This allows a further needle tip to be inserted into the forceps while keeping the needle in a position parallel to the forceps, minimizing the possibility of needle sticking. The forceps can also be used as a standard forceps for grasping tissue without damaging the tissue.

  FIG. 13 depicts an embodiment of a composite forceps. The composite forceps includes a first arm 20 and a second arm 24. The first NR 30 is disposed at the distal end of the first arm 20 of the composite forceps, and the second NR 31 is disposed in proximity to the first NR 30. The first NR 30 is integrated with the first arm 20, and the first NR 30 has an opening 32 at the distal end of the first arm through which the needle 14 can be inserted, and a needle attachment that grips the needle after insertion. A material. The purpose of the first NR 30 is to hold the needle while the user ties the suture and to cover the tip of the needle during forceps transport. The second NR 31 comprises a soft needle attachment material that forms a continuous surface with a portion of the first arm 20, but may be any of the NRs of the embodiments described herein. The composite forceps may be disposable or reusable. The second NR may be used, for example, during continuous stitching.

  FIG. 14A is a side view of a particular forceps embodiment. The forceps comprises an NR having features of both the NR ridge embodiment and the sandwich NR embodiment. The first forceps arm 20 includes a housing 11 at the distal end of the arm that includes a needle attachment material 17, substantially as described in FIG. However, the housing 11 further comprises a slot along the longitudinal axis of the forceps arm. The second forceps arm 24 includes a raised portion 26 as illustrated in FIG. 10 on the inner distal surface, and the raised portion 26 fits in the slot of the first forceps arm 20 when the forceps are in the closed position. Are positioned as follows. When the needle 14 is inserted through the needle attachment material 17 and the forceps are closed, the raised portion 26 comes into contact with the needle 14 and the needle 14 is pressed toward the inner surface of the first forceps arm, so that the gripping force of the needle is increased. Increase.

  FIG. 14B shows the forceps in the closed position for gripping the tissue 33. The needle 14 is inserted into the needle mounting material 17 on the side of the NR / forceps. The drawing shows the forceps gripping the tissue 33 even though the NR is located on the outer surface of the distal end of the forceps arm and the needle insertion point is on the side of the forceps arm. NR is suitable for receiving and mounting the surgical needle 14.

  FIG. 15 shows a modification of the chamber type NR. The illustration illustrates that the hole 13 that leads to the soft needle mounting material in the chamber 12 may be located anywhere in the housing 11. The drawings illustrate that when attached to the forceps arm, the holes may be located on the inner surface of the forceps arm (upper compartment) or on the outer surface of the forceps arm (lower compartment). The illustration also illustrates that the needle may be inserted toward the proximal end of the forceps (left compartment) or the distal end of the forceps (right compartment) regardless of the position of the hole.

  FIG. 16 shows a “micro” forceps with NR2 suitable for use with a relatively small surgical needle, such as a surgical needle used in cardiovascular surgery. The NR2 is provided on a holder 34 that is detachably disposed on the first forceps arm 20. The NR is relatively small in size and is located at the distal tip of the holder. The first forceps arm 20 is shorter than the second forceps arm 24, and the first forceps arm 20 including the holder 34 is longer than the second forceps arm 24 when the holder 34 is positioned on the first forceps arm 20. Now, they are configured to be substantially the same. Since the NR (with holder) is relatively small in size, a cartridge for use with such “minute” forceps may have multiple NRs (with holder).

  Thus, the present invention has been described with reference to certain embodiments described above. It will be appreciated that these embodiments are susceptible to various modifications and alternatives widely known to those skilled in the art without departing from the spirit and scope of the present invention. Thus, although specific embodiments have been described, these are only examples and do not limit the scope of the invention.

Claims (32)

  A cartridge for storing and / or disposing of a needle receiver (NR), suitable for attachment of a surgical needle, an optional needle with or without a suture, and a housing; The housing includes at least one opening sized for insertion and removal of a forceps arm, the opening relative to a distal end of the arm of the forceps upon insertion of the arm, A cartridge arranged to allow attachment or removal of the NR and an optional needle with or without suture.   The cartridge according to claim 1, further comprising an indicator for identifying whether the state of the cartridge is new or used.   Combined with a forceps comprising a first arm and a second arm connected at a base end, the first arm and the second arm being increased or decreased between the first arm and the second arm A space is formed, and the needle receiver (NR) is attached to at least one of an inner surface, an outer surface, and a side surface of an end of the arm at the distal end of the arm. Cartridge.   The cartridge according to claim 3, wherein the NR can be penetrated by a surgical needle.   The cartridge according to claim 4, wherein the NR is made of an elastomer material.   The cartridge of claim 5, wherein the elastomeric material is synthetic rubber.   The NR is composed of an elastomer material having a hollow core, and the NR has a first layer, a space, and a second layer to which the surgical needle can be attached by a shape lock in the cross-section. And a cartridge according to claim 4.   The NR is composed of an elastomeric material having a core composed of a filling material selected from gels, foams, beads, and liquids, and the NR is in cross section, the first layer, the filling material, and the material A cartridge according to claim 4, wherein the NR comprises a second layer to which the surgical needle can be attached by a shape lock.   The cartridge of claim 4, wherein the NR comprises a soft plastic material.   The cartridge according to claim 4, wherein the NR includes a wire network.   Combined with a forceps comprising a first arm and a second arm connected at a base end, the first arm and the second arm being increased or decreased between the first arm and the second arm The first arm has a slot along the longitudinal axis of the forceps arm at the distal end of the arm and the needle attachment material on the inner surface of the end of the arm The second forceps arm has a straight flat ridge on the inner surface of the end of the arm at the distal end of the arm, the ridge acting on the needle 3. A cartridge according to claim 1 or 2, wherein the forceps is positioned to fit within the slot when in the closed position.   The cartridge according to claim 3, wherein the NR is made of a magnetic material.   The cartridge according to claim 3, wherein the NR is made of an adhesive material.   4. A cartridge according to claim 3, wherein the NR comprises a guide gripping mechanism selected from a plunger and a clamp.   The cartridge of claim 13, wherein the NR comprises a plunger mechanism.   The cartridge according to claim 13, wherein the NR includes a clamp mechanism.   The cartridge according to claim 1, wherein at least a part of the cartridge is formed integrally with at least a part of the NR.   18. A cartridge according to any one of the preceding claims, further comprising one or more additional NRs suitable for attaching a surgical needle.   19. A suturing system comprising a plurality of cartridges according to any one of claims 1 to 18, optionally comprising rails or other holding mechanisms for collectively holding the cartridges within an operating room.   The system according to claim 19, further comprising at least one of a forceps and a needle holder arranged to be attached to the NR. A method for preventing needle stick during a suturing procedure,
a. Inserting a forceps arm into a needle disposal / storage cartridge comprising NR, needle and suture;
b. Attaching an arm directly or indirectly to the NR, thereby loading the forceps with the NR, needle and suture;
c. Removing the forceps arm from the cartridge;
d. Reinserting the forceps arm into the cartridge after use, thereby discarding the NR, the needle and the suture;
e. Removing the forceps arm from the cartridge, and preventing needle stick during a suturing procedure.   The method of claim 21, further comprising retaining the NR in the cartridge to prevent secondary reuse.   23. The method of claim 21 or 22, further comprising the step of breaking at least a portion of the NR or the needle.   Combined with a composite forceps comprising a first arm and a second arm connected at the base end, the first arm and the second arm increasing or decreasing between the first arm and the second arm The NR comprises a relatively weak first NR at a distal end of an arm and a relatively strong second NR proximate to the first NR. The cartridge according to 1 or 2.   2. A combination with a forceps at the distal end of the arm on the inner surface, outer surface or side surface of the end of the arm and comprising an NR suitable for receiving and attaching a surgical needle while grasping tissue. Or the cartridge of 2.   The cartridge according to claim 25, wherein the NR is a chamber type NR.   The cartridge according to claim 25, wherein the NR is a sandwich type NR. Forceps suitable for grasping a surgical needle,
a. A first arm and a second arm connected at a base end;
b. A pair of claws at the distal end of each arm, substantially perpendicular to the longitudinal axis of the forceps;
c. First needle guide means proximate to the pair of claws on the second arm;
d. And optional second needle guide means proximate to the first needle guide means on the second arm,
The pair of claws on the second arm are opposed to the pair of claws on the first arm, and the pair of claws on the first arm is more than the pair of claws when the forceps are in the closed position. There are also forceps on the distal side.   29. The forceps according to claim 28, wherein the first needle guide means is a grooved ridge or a pair of claws.   The forceps according to claim 28, wherein the second needle guide means comprises a hollow metal cylindrical body.   29. The forceps according to claim 28, further comprising means for releasably locking the forceps in place.   Forceps, cartridge or suturing kit as substantially described above with reference to the description, drawings and claims.

Images