[go: up one dir, main page]

WO2011066533A1 - Ensemble pinces et procédé de rapprochement des berges d'une plaie dans un tissu - Google Patents

Ensemble pinces et procédé de rapprochement des berges d'une plaie dans un tissu Download PDF

Info

Publication number
WO2011066533A1
WO2011066533A1 PCT/US2010/058321 US2010058321W WO2011066533A1 WO 2011066533 A1 WO2011066533 A1 WO 2011066533A1 US 2010058321 W US2010058321 W US 2010058321W WO 2011066533 A1 WO2011066533 A1 WO 2011066533A1
Authority
WO
WIPO (PCT)
Prior art keywords
clip
tissue
clips
wound
approximating
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/058321
Other languages
English (en)
Inventor
Warren P. Williamson, Iv
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CLEVEX Inc
Original Assignee
CLEVEX Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CLEVEX Inc filed Critical CLEVEX Inc
Publication of WO2011066533A1 publication Critical patent/WO2011066533A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/128—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/081—Tissue approximator

Definitions

  • This invention generally relates to the surgical approximation of tissue.
  • Skin biopsy is one of the most important diagnostic tests for skin disorders. Skin biopsy procedures are performed in many ways. If an improper technique is used to remove a lesion and it turns out to be malignant, proper diagnosis of the stage of cancer may be impossible. However, once a pathologist has established the presence of malignant cells, a second surgery is almost always performed to make certain all remnants of the cancerous tissue have been removed; this procedure is called a full depth excisional biopsy with margin. As such, these procedures must take out large portions of tissue to be certain that not only are the malignant cells removed but that there is sufficient clear margin of healthy tissue surrounding the malignant tissue. The margin and diagnosis must be confirmed through histopathology preparation of the biopsy sample and cross-sections of the excised tissue reviewed by a pathologist. Therefore, in contrast to a simple biopsy procedure which is more exploratory than curative in nature, a full depth excision is much more invasive and leaves a larger and deeper wound to close.
  • a scalpel is used to make this type of surgical incision, and a hemostatic device, such as a cautery tool or clotting agent, is used to stop the bleeding while removing the tissue in question and approximating the severed edges with sutures to close the wound for healing.
  • a hemostatic device such as a cautery tool or clotting agent
  • a layered closure technique include a subcutaneous set of interrupted sutures to approximate the base layers of the wound, and a second set of epidermis or surface layer sutures to approximate the epidermis layer of the skin.
  • a layered closure solves this problem by approximating the base layers of the skin directly above the fat. This layer is known as the reticular dermis. This layer of the skin is highly fibrous and represents the strongest tensile strength portion of the organ. Therefore, when a large wound needs to be closed the majority of the stresses required to close the wound are taken up by the reticular dermis.
  • a layered closure is required for a size threshold at around 10-12mm in length, or when the skin has been fully penetrated and is bleeding profusely.
  • a layered closure requires that a primary set of sutures be placed deep in the wound base to
  • the doctor can use one half of the length of the suture for the first placement, then cut it in half for a second placement.
  • Proper technique for suturing requires at least 6 to 8 inches of free suture length to be able to tie the knots with gloves on. Therefore, this technique requires many suture packages for a single wound closure resulting in an inefficient and expensive use of suture, not to mention a time-consuming procedure for the doctor or surgeon.
  • the base layer sutures are made of an absorbable material either natural (gut) or synthetic. The body must be able to break down this material to absorb it. The absorption process leaves behind scar material in the wound.
  • the present invention in one embodiment, provides a clip assembly for approximating a wound in tissue.
  • the clip assembly includes a first clip and a second clip.
  • the first and second clips each include tissue penetrating structure movable between an open condition for receiving the tissue adjacent to the wound and a closed condition in which the tissue penetrating structure of the first and second clips penetrates the tissue as the clips close the wound.
  • the first and second clips are positioned generally adjacent to each other.
  • the tissue penetrating structure of the first clip is configured to penetrate into a deeper portion of the tissue than the tissue penetrating structure of the second clip when moving from the open condition to the closed condition.
  • Connecting structure couples the first and second clips together in a manner allowing movement of the first and second clips between the opened and closed conditions.
  • the first and second clips may be annular in shape, in the open condition, and the tissue penetrating structure may be carried on an inwardly facing portion of each clip.
  • the tissue penetrating structures of the first and second clips may each comprise opposed teeth with sharpened points directed toward each other.
  • the opposed teeth of each clip move toward each other and into the tissue when the first and second clips are moved from the open condition to the closed condition.
  • the teeth of at least one of the first and second clips may respectively interdigitate in the closed condition.
  • the first and second clips may increase in length along a longitudinal axis upon moving from the open condition to the closed condition.
  • the tissue penetrating structure of the first clip may be configured to approximate the reticular bed of a wound in skin tissue
  • the tissue penetrating structure of the second clip may be configured to approximate the epidermis of the wound in the skin tissue.
  • At least some of the opposed teeth of the first clip may be longer than at least some teeth of the second clip, and the first and second clips may each be formed from flat plates.
  • the opposed teeth of the first clip may be angled downwardly in a direction configured toward the tissue to be approximated.
  • the first and second clips may each include hinge structure at opposite ends.
  • the tissue penetrating structure on each of the annularly shaped first and second clips may be included on respective straight and angled portions in the open condition. The angled portions may then become more straightened along the longitudinal axis of each clip when moving to the closed condition.
  • a device including a clip assembly as generally discussed, and a clip driver and tissue cutting device carrying the clip.
  • the clip driver and cutting device includes a clip assembly holder, a blade and actuating structure configured to move the clip assembly from the open condition to the closed condition and move the blade for severing a portion of the tissue.
  • a clip assembly for approximating a wound in tissue.
  • the clip assembly includes a first clip and a second clip.
  • the first and second clips each include tissue approximating structure movable between an open condition for receiving the tissue adjacent to the wound and a closed condition in which the tissue approximating structure of the first and second clips engages the tissue as the clips close the wound.
  • the first and second clips are positioned generally adjacent to each other and the tissue approximating structure of the first clip is configured to engage a first portion of the tissue and the tissue approximating structure of the second clip is configured to engage a second portion of the tissue located proximal to the first portion when moving from the open condition to the closed condition.
  • Connecting structure couples the first and second clips together in a manner allowing movement of the first and second clips between the open and closed conditions.
  • the first and second clips may be movable independent of each other for at least a portion of the movement from the open to closed condition and/or may move together from the open to the closed condition.
  • the tissue approximating structures may comprise a pair of opposed, at least substantially non-penetrating elements for compressing the tissue.
  • the tissue approximating structure of the first clip may comprise a pair of opposed, at least substantially non-penetrating elements for compressing the tissue, while the second clip comprises a pair of opposed tissue penetrating elements.
  • Methods of approximating a wound in tissue are also provided.
  • the method may include placing the clip assembly adjacent the tissue with the first and second clips in the open condition, moving the first and second clips from the open condition towards the closed condition while penetrating the tissue with the tissue penetrating structure of the first and second clips, and penetrating into the tissue more deeply with the tissue penetrating structure of the first clip than with the tissue penetrating structure of the second clip.
  • the clip assembly is placed adjacent the tissue with the first and second clips in the open condition, the first and second clips are moved from the open condition towards the closed condition while engaging the tissue with tissue approximating structure of the first and second clips, and the tissue is engaged more distally with the tissue approximating structure of the first clip than with the tissue approximating structure of the second clip.
  • each clip may be compressed so as to elongate the clips and apply tension to the wound along the length thereof while penetrating into the tissue or otherwise engaging the tissue with the first and second clips.
  • Figure 1 is a side view of the lesion excision and closure device used to remove unwanted skin lesions and close resulting wound.
  • Figure 2 is a top perspective view of the excision device shown in Figure
  • Figure 3 is a perspective view and shows the device placed on a subject lesion.
  • Figure 4 is a perspective view similar to Figure 3 showing use of a skin hook.
  • Figure 5 is a top view of the double clip assembly including a surface clip placed atop of a subcutaneous clip.
  • Figure 6 is similar to Figure 5 but shows a partially closed clip assembly.
  • Figure 7 shows a cutaway view of the clip assembly depicted in Figure
  • Figure 8 shows a cutaway view of clip assembly fully closed.
  • Figure 9 shows an isometric view of the clip assembly in fully closed condition with no skin between the teeth.
  • Figure 10 shows a clip assembly in the closed condition with everted skin protruding above the top clip surface.
  • Figure 1 1 shows a clip assembly partially closed to allow viewing of the different teeth length.
  • Figure 12 is an exploded view of the clip assembly containing the surface clip, the deep penetrating clip, and the alignment guide.
  • Figure 13 is a transverse cross-sectional view of the clip assembly taken generally perpendicular to the long axis of the assembly.
  • Figure 14 is a view similar to Figure 13 but shows the initial driver movement pushing the deep clip into the reticular dermis prior to setting of the surface clip.
  • Figure 15 is a view similar to Figure 13 but shows where the deep clip and surface clip move together engaging two sides of the lesion to be excised.
  • Figure 16 shows the final step in the incision and wound closure process whereby the blade transects the lesion.
  • Figure 17 is a cross-sectional view of the skin lesion excision and device.
  • Figure 18 is a similar cross-sectional depiction to Figure 17, however, showing the lever partially actuated corresponding to Figure 15 in the clip deployment sequence which has both deep and surface clips engaged in skin.
  • Figure 19 shows full actuation of the device corresponding to full clip closure and lesion removal depicted in Figure 16.
  • Figure 20 is a cross-sectional view of the device showing the top view of the clip assembly in the distal end of the actuating device.
  • Figure 21 shows an exploded view of the components that make up the device assembly.
  • Figure 22 is a top view and shows an alternate embodiment of the double clip utilizing connection tabs to hold the clips together.
  • Figure 23 shows a typical cross-section of skin broken into its geographic descriptions according to depth.
  • Figure 23A is a perspective view, cut away to show an alternative embodiment of the clip assembly having an upper or proximal set of tissue
  • tissue penetrating elements in the form of tissue penetrating elements and a lower or distal set of tissue approximating elements in the form of flat, rounded bars interspersed with tissue penetrating teeth.
  • Figure 24 is a cutaway view of the colon and endoscopic polyp removal tool with an endoscope for visualization of the procedure and grasper used to pull the polyp up through the aperture of the clip assembly.
  • Figure 25 is an exploded view of endoscopic device used to deploy and of a clip assembly used for polyp removal inside a body cavity.
  • Figure 26 is a partially cutaway top view of the tool described in Figure
  • Figure 27 is a partially cutaway top view of the endoscopic actuating device showing the clip assembly in the closed position.
  • Figure 28 is a perspective view, cut away to show an alternative embodiment of the clip assembly having an upper or proximal set of tissue
  • tissue penetrating elements in the form of tissue penetrating elements and a lower or distal set of tissue approximating elements in the form of flat, rounded bars.
  • Figure 29 is a cross sectional view of the clip assembly shown in Figure
  • tissue 28 engaged with tissue, such as mucosal tissue.
  • this invention produces the same closure effect as a layered suture technique by combining the approximation of the deep base layer with a fine controlled surface layer approximation.
  • use of the invention provides both a deep approximating clip closure and a surface tension clip element.
  • Each surface clip element is capable of engaging the thinner upper layers of the skin and spreading the approximation forces out like a washer under a bolt head. By spreading out the approximation forces, the skin is subjected to less localized stretching trauma which results in finer or nonexistent "tracks" adjacent to the wound edges. By interdigitating or alternating the skin engagement hooks, close
  • a device is directed towards the more common procedures whereby a skin lesion biopsy results in an opening that is much larger than can be comfortably closed by previously disclosed skin clip devices.
  • the skin closure mechanism of the invention comprises two separate elements in a double clip "stacked" configuration -each clip is specifically designed for its role in the closure of the wound.
  • One clip acts as a closure member in the deep portion (e.g., reticular bed) of the wound and a second clip is responsible for the closure of the skin surface or epidermis.
  • the smaller epidermis- engaging teeth approximate and evert the outer edges of the skin to create intimal layer closure.
  • This type of closure is thought of as the best way to close a skin wound, but in practice (with sutures) it is very difficult to obtain. With the inventive clip assembly, it is hard not to obtain excellent skin approximation and epidermis eversion.
  • the long teeth of the deep-penetrating clip engage the skin first, penetrating deeply into the reticular bed and the shorter teeth of the surface clip gather and pinch together the epidermis skin.
  • the longer base teeth engage the wound first in the pre-cut position compressing the deepest layers at the base of the skin prior to severing the biopsy.
  • the upper layer or surface clip is stacked directly on top of the deep-penetrating clip; it approximates only the upper epidermis during closure.
  • the teeth of the surface clip are constructed especially for surface closure with shorter teeth each spaced by a distance that allows capillary flow to the skin while still interdigitating and compressing the tissue between the rows of teeth on opposite sides of the wound.
  • the upper clip assures that the inside intima of the skin are held in close approximation during the healing process.
  • the legs of the clips which fold inward towards the wound have teeth disposed on their inside edges. Because the legs rotate around each end where they bend, the teeth disposed on the legs tend to stretch the wounds into a thin straight line. This has advantages of smoothing out any misalignments and creating a very smooth, flat, straight scar.
  • the stacked clips are held together with a plastic alignment plate.
  • the alignment plate utilizes posts which extend up through the penetrating clip and surface clip. Flaps fold over each quarter to keep the entire assembly together throughout manufacturing, deployment and healing.
  • the alignment plate is constructed from an injection molded thermoplastic such as polypropylene or polyethylene. It has the additional advantage since these materials are by and large inert which means very few patients will become sensitized to contact dermatitis. It also tends to smooth out the outer surfaces of the clip assembly to prevent snagging on clothing or bath towels.
  • other alternative embodiments can be employed without materially diverting from the scope of the invention.
  • Some lesions sized, for instance, between 6 and 9mm require only a single clip.
  • the single clip employs both deep-penetrating and surface teeth on the same clip. Since the overall amount of skin to be gathered and approximated does not have nearly the amount of overall skin stress, staggered high and low teeth would be sufficient. This is also an excellent way to address the problem of thicker skin with smaller lesions. That is to say, when the overall skin thickness increases, one may need to use a special clip with a hybrid tooth design in order to facilitate the gathering and deep approximation that the longer teeth provide. This may be the case even when the overall lesion size may be smaller. Skin such as on the back, thighs or buttocks is typically thinner than those of the belly or arms or the fleshy sides of the lower limbs.
  • One or more embodiments of this invention enhance the skin penetrating attributes of the wound tensioning clips by controlling the skin edges with specially fabricated tines, or tooth profiles which engage the skin.
  • the tooth should be sharp enough to initially penetrate the epidermis to fix the tooth into the skin. It takes a rather small, sharp point to penetrate the skin, however if the tooth profile is too long and slender, the tooth can either bend or over-penetrate. Over-penetration is a condition in which the depth of the penetrating tip is not controlled. This will cause a situation where the tooth continues to penetrate into the tissue during the normal course of skin stretching and relaxation during the healing process.
  • the novel tooth profile disclosed in this application solves this problem by having a stepped profile.
  • the penetrating points used in the base penetrating layer are of a different shape and configuration with an extended sharp length before the
  • the clip assembly closes on the tented skin that is pulled through the aperture; the tines are set into the skin prior to severing the lesion. Therefore, the clip assembly tines are set into two straight lines (top and bottom stacked clips) together as the compressed epidermis everts and rolls back on the top side of each penetrating clip. This creates a very positive condition for healing and minimized scar production. As the wound heals, the tissue above the clip assembly sloughs off and dies. The tissue below the clip assembly remains patent and the wound heals with minimum scar production.
  • the overall size of the clip assembly is reduced when compared to previous disclosures.
  • each strand is individual and flexible, therefore discomfort to the patient while the wound is healing is minimal.
  • the majority of the discomfort does not lie in the penetration of the foreign body clip in the skin but, in fact, comes from snagging the clip assembly on clothing or other objects. So, the overall size of the clip assembly, even though temporarily covered with a Band-Aid or adhesive patch, is important to patients.
  • the novel improvement of placing the tines on the legs is advantageous to maximize the use of the size of a larger clip assembly capable of engaging a 12mm long excision. It was discovered that by placing teeth on the legs, the legs traveled in a more radial path as they closed in addition to approaching each other from opposite sides. However, from the standpoint of the tissue edges in relationship to the tissue at the center of the wound, the teeth on the legs tend to stretch the wound line from the center outwards to each end as the clip assembly closes. This helps create a very fine approximation line with no puckers or weeping during the healing process. One will also notice that the base layer clip appears to open farther than the surface layer clip.
  • the base layer clip begins its closure process first through external driver mechanisms in the delivery device. Once the base layer tines have been set into the tissue, the driver catches up with the surface layer clip and both clips together are driven the last two thirds of the closure stroke.
  • a plastic alignment guard is placed around each clip and secured from top and bottom to hold the two stacked clips together as a unitary device. Binding posts extend from the base side to the surface side, which also become gliding posts which keep each clip in proper alignment in relationship to the other clip as they close, preventing any skewing between the two clips as they gather the skin for wound closure.
  • the alignment guard is made of a non-sensitizing plastic such as polyethylene or polycarbonate. This has the added feature of preventing the clip material, which can be sharp from coming in contact with the skin and/or clothing or irritating the skin due to abrasion in areas where the body moves and skin stretching is inevitable.
  • This clip design lends itself very well to other applications in wound closure. For instance; fistulas within the large and small intestine can be pulled through the clip aperture and severed from the base of the structure. After healing, the clip assembly will slough off and become excreted by the body. A smoother more enclosing alignment guard surrounding the clip assembly would make certain that all exposed edges are smooth and protected during the excretion process. Different sizes and application-specific geometry could also be used in areas such as hemorrhoid isolation. The structure would be drawn through the clip assembly and severed after closure. A smooth alignment guard again would assure that it would be well tolerated in the rectum or sigmoid colon until sloughed off and excreted. In certain
  • tissue-penetrating teeth and pressure bars may be used.
  • the device and wound closure clip assembly are used in conjunction to excise skin lesions and close the resulting wound in a single step operation.
  • the system consists of three basic units. The first being the excision device 1 , which actuates the closing of the wound clip assembly and excision of the lesion with a blade internal to the device.
  • the second component is the wound closure clip assembly 10, used to approximate the edges of the wound, prevent bleeding and promote healthy, cosmetically pleasing wound closure.
  • the third tool used for this procedure is a skin hook 12. While not part of the inventive structure of this patent, specific geometry and sharpness of the skin hook is essential to a good procedure. For reference, an example is a MiltexTM 21 -90 Cottle type stainless steel skin hook.
  • the skin hook 12 used to draw the lesion up through the aperture 6 of the device 1 in a tented fashion as shown in the figures.
  • Figure 1 is a right side view of the skin lesion excision and wound closure device 1 with a proximal end comprising user handle 3 and actuating lever 4.
  • the distal end 2 holds clip assembly; the proximal end 3 is manipulated by the user to close the clip assembly and excise the wound.
  • the distal end of the device 1 houses an oblong-shaped through-hole, or aperture 6 with wound closure clip assembly 10 surrounding the aperture on the lower surface of a skin contact pad.
  • Stabilizing pad 5 allows the user to push the device onto the patient with moderate pressure to stabilize the device 1 during the procedure.
  • Figure 2 shows a top view of the skin lesion excision and wound closure device 1 , clearly depicting the aperture 6.
  • This device 1 can be used anywhere where the closure of a wound is required.
  • This end 2 contains an opening or aperture 6 where the skin lesion is drawn up through the aperture and clip assembly 10 is used to close wound prior to the tissue being severed.
  • the device is placed against the patient pushing down on stabilizing pad 5 and helps to hold the device steady while actuating the lever 4. Examples outlined in this disclosure are directed towards the removal of questionable lesions and the closure of the opening produced as a result thereof.
  • FIG. 3 depicts the beginning of the excision procedure.
  • User has grasped the handle of the device with his left hand and a skin hook 12 being prepared to lift the lesion up through the aperture 6 of the device.
  • the aperture 6 is placed over the skin lesion 1 1 which is to be removed from the patient.
  • the lesion 1 1 is centered within the aperture 6 to be certain that clear, unaffected margins are equal on all sides.
  • Skin hook 12 penetrates the skin adjacent to the lesion 1 1 and is then rotated so that the angled hook portion of the skin hook 12 penetrates directly under the center of the lesion 1 1 . This allows the surgeon to pull up on the lesion 1 1 , drawing it through and above the aperture 6. By pulling up on the lesion 1 1 , it draws the various layers of the skin into intimate contact with the wound closure teeth on the lower side of the skin contact pad.
  • Figure 4 shows the proper positioning of the skin hook 12 under the lesion 1 1 and the lesion 1 1 being drawn up through the aperture 6.
  • a larger, cross- sectional detail view of the distal end of the device 1 is shown in Figure 13, where the skin hook 12 has penetrated the lesion 1 1 and drawn it up through the aperture 6.
  • Figure 5 shows the top view of the double layer stacked skin clip 10 used in the preferred embodiment of this invention.
  • a plastic alignment guard feature holds the clips together.
  • the surface and deep clips are offset prior to actuation to allow the longer teeth of the deep penetrating clip to enter the tissue first then the clips are moved together compressing the lower portions of the wound prior to the top clip engaging in the edges of the skin.
  • It consists of three main parts: the deep-penetrating clip 14, which lies closest to the patient's skin in use; directly adjacent and on top of the deep-penetrating clip 14 lays the surface penetrating clip 13; surrounding both clips 13, 14 is a thermoplastic molded alignment plate 15.
  • This plate 15 sandwiches the two metal clips 13, 14 together, both holding them in place and then guiding them to keep their alignment and relationship to one another as the clip assembly 10 is driven to a closed state with the closure device 1 .
  • the deep clip 14 consists of longer penetrating teeth 22 which are angled down towards the base of the wound. This differs from the surface clip 13 which has shorter teeth 21 used to gather and close the upper layers or epidermis of the skin.
  • the two clips 13, 14 differ because of the needs to close different parts of the wound. Just as interrupted base layer sutures close the reticular dermis of the wound, the long, extended teeth 22 of the deep clip 14 penetrate and hold the base layers of the skin together to prevent pocketing below the surface.
  • radial foci 24 depicts the radial foci which the teeth will pivot around as the clip assembly is closed.
  • FIG. 5 the alignment plate 15 is placed first with snap pins 16 facing upward. Deep clip 14 is placed over the alignment pins 16 and then the surface clip 13 is placed on top of the clip 14. The upper ears 28 are folded over on top of the alignment plate pins 16 and snapped in place on the alignment plate.
  • the alignment plate ears 28 have thin, living hinges 29 which allow the ears to fold over easily yet provide easy sliding movement of both metal clips inside the assembled final clip. Because the alignment plate 15 is also made from an inert plastic, it acts as a barrier to prevent direct contact of the metal clip structure 13, 14 with the patient to lessen any dermatitis issues with metal surfaces. Although not shown in the figures, all edges of the alignment plate 15 will be rounded and smoothed to prevent snagging on clothing or covering bandages.
  • Figure 7 shows a cross-section through Figure 5, giving greater clarity to the differences between the deep-penetrating clip 14 and the surface clip 13. Note that on the deep-penetrating clip 14 every other tooth is a long deep-penetrating shape which has been bent downward. The reason for this will become more clear when showing a section through the closed clip, such as in Figure 8, where one notices that the deep-penetrating teeth 22 will actually cross over each other. This is used to gather and approximate the reticular dermis and prevent pocketing below the surface.
  • Figure 9 depicts a fully closed clip assembly 10 showing the
  • Figure 9 shows the clip assembly closed without any skin between the teeth.
  • Figure 10 is a depiction of the everted layers of skin standing above the surface clip 13.
  • Figure 1 1 shows a partially closed clip assembly. Bending zones 19 and
  • FIGS. 20 show where the clip assembly 10 has been narrowed in thickness so that it will bend in a predetermined configuration to go from a generally open shape to a linear closed shape.
  • Driver engagement slots 18 are shown in this figure. These slots 18 help to align the driver and clip assembly in the device 1 to prevent the clip assembly 10 from skewing sideways if any torque is applied by the user during the closing process. If torque is applied without these driver engagement slots, there would be a possibility that the clip assembly 10 will not close properly and the teeth 21 , 22 will not interdigitate but rather hit one another point-to-point. This will then space the clip assembly 10 apart and prevent the wound from being fully closed and prevent the everted tissue edges from approximating.
  • Figure 12 shows an exploded view of the clip assembly 10.
  • the X-shaped feature in the center of the alignment plate 15 is a runner system used to fill the part during injection molding. It also serves to hold the alignment plate 15 in its molded shape to facilitate attaching the clips 13, 14 and fixture the parts for assembly processes. Once the assembly is completed, the four legs of the "X" are removed and discarded.
  • Figure 13 depicts a cross-section of the distal end 2 of the excision and closure device 1 , the section is taken generally through the aperture 6.
  • This cross- sectional view which corresponds with Figure 4 of the procedure where the tissue has been hooked and is being pulled up through the aperture 6 prior to the closure. Notice how the two clips 13, 14 remain retracted away from the skin at this point. Push driver 31 and pull driver 32 are currently engaging only the deep clip 14 as it will be the first clip to close requiring more travel to travel deeper into the tissue.
  • Figure 14 shows the same cross-section without a housing being shown. In this Figure, it is important to see how the deep clip teeth 22 have begun to penetrate through the epidermis into the reticular dermis prior to movement of the blade 30 and surface clip 13. This pre-closure of the deep clip 14 also stabilizes the clip assembly and secures the lesion from retracting back below the blade level should the user accidentally relax the tension on the skin hook 12 while squeezing the lever 4, actuating the device.
  • Figure 15 shows the point at which the push driver 31 and pull driver 32 are now contacting and driving both clips 13, 14 simultaneously. Teeth on legs begin engaging and stretching the wound laterally. Surface and deep teeth are now moving in a more linear, non-stretching manner with direct opposition across the wound.
  • Excision blade has moved into position about to begin the excision. During this phase the tips of the teeth 21 , 22 are almost fully penetrated in both clips 13, 14. The deep clip 14 has begun cinching together the walls of the reticular dermis 34 directly above the fat layer 33.
  • Figure 16 shows the last step where the clip assembly 10 is completely closed and the blade 30 has traveled across the top of the clip assembly 10 severing the skin lesion 1 1 . It is important to understand the sequence of pre-closing the clip assembly 10 and setting the clip teeth 21 , 22 into the tissue prior to the lesion 1 1 being severed. Figures 17-19 will explain the corresponding mechanical actions inside the driving device 1 which ensure that the clips 13, 14 close properly and that the blade 30 travels at the end of the stroke to sever the tissue.
  • FIG 17 is a cross-sectional view through the device 1 showing the handle 9, drivers 31 and 32 and actuator lever 4.
  • the lever 4 is pulled to close the clip assembly 10 and sever the tissue.
  • the blade driver 7 is not directly connected to the blade 30.
  • the lever 4 pivots around the shaft 36.
  • the lower driver 32 is called a pull driver because as the lever 4 rotates clockwise that driver will pull the distal end of the clip assembly 10 towards the user.
  • FIG. 18 shows the time and sequence when the blade 30 begins to move transversely across the top of the clip assembly 10 beginning to sever the tissue 1 1 (not shown).
  • Figure 20 is a cross-section taken transversely across the distal end of the device 1 along section plane BB in Figure 17.
  • This cross-sectional top view clearly depicts the open clip assembly 10 placed evenly around the aperture 6 pull driver 32 surrounds the distal side of the clip assembly 10 while pusher 31 surrounds the opposite side of the clip assembly 10.
  • Blade 30 is shown transparently above the pull driver 32 and part of the surface clip 13. Details of the push and pull drivers 31 , 32 are more clearly seen in the isometric assembly view of Figure 21 .
  • Figure 22 is an alternate embodiment 37 whereby the alignment guide
  • Retention tabs 38 are used instead to hold the two clips 13, 14 together during deployment and healing.
  • the tabs 38 allow a sliding movement between the top and bottom clips 13, 14 while still keeping them tightly held in alignment.
  • Figure 23 is a cross-section of a typical section of skin showing the different layers 35 including epidermis, dermis and hypodermis.
  • the thicker, connective tissue in the reticular region 34 is where the deep penetrating teeth 22 penetrate to close the deep wound pocket.
  • the adipose layer 33 is the interface between the reticular region 34 and the fat.
  • the dotted line shows a V-shaped cutting line which depicts the optimal excision shape for removal of a skin lesion performed by this device.
  • the new wound closure clip assembly disclosed herein can be modified for other tissue clamping uses.
  • One example of this would be a modification for use as a colon polyp removal clip assembly.
  • the clip assembly would still use a surface layer clip and possibly a second clip that would have wider spaced, short teeth along the clip's inner edges.
  • the clip used to compress a colon polyp would not need the deep-penetrating teeth.
  • teeth 22 would be interspersed with flat pressure bars 102 between them. The pressure bars 102 would tend to compress the tissue and allow healing of the mucosal surface while the teeth 22 held tissue in place during the healing process. After the tissue has healed, the clip 100' will pass through the digestive system naturally.
  • a smooth outer coating of polyethylene will surround the clip 100' much like the alignment plate in the previous disclosure.
  • Figure 24 depicts use of the device in a large bowel or rectum.
  • An elongated, endoscopic type delivery tool will need to be employed to close the clip assembly on a colon polyp.
  • Figure 24 shows an elongated tool 50 with flexible section 56 which can be used to access remote sites of the rectum and large bowel where the polyp 67 is located.
  • a flexible endoscope 74 with grasper 68 is used to draw the polyp 67 through the aperture of the endo clip 51 .
  • Grasper 68 is used under direct visualization of the fiber-optic endoscope 74.
  • Figure 24 shows cutaway view of the large bowel polyp 67 after it has been pulled up through the Endo clip 51 under direct visualization of endoscopic camera 74.
  • Grasper 68 is used to draw polyp up through the clip 51 prior to removal.
  • Driver tool 50 is shown flexed to obtain proper positioning. Once the clip 51 has been fired and the lesion 67 severed from the colon wall, the clip 51 will remain engaged with the tissue until the tissue is healed and the clip 51 sloughs off naturally.
  • Figure 25 shows an exploded view of the clip driver system 50.
  • Endo clip 51 is disposed between two driving levers 52 and 53.
  • Levers have pivoting center holes 52 and 53 which they are free to rotate about.
  • a flat spring 54 biases the levers 52, 53 towards each other so that the lever alignment tab 65 will engage in clip alignment slots 66.
  • Driving levers 52, 53 have cam surfaces 70 which engage on ramping surfaces 69 and 72 of a wedge driver 55. When wedge driver 55 is pushed forward, the ramp surfaces 69, 72 engage cam surfaces 70 on the levers 52 and 53 to compress and close the Endo clip 51 .
  • the blade driver 57 advances forward.
  • the blade driver 57 has blade 58 connected to it, severing the polyp above the clip.
  • Drivers for the blade 58 and levers 52, 53 have flexible sections 56 and 59 which allow the head of the device 50 to be flexed during use at flexible section 63 and 71 in the housing.
  • Figures 26 and 27 show partially cutaway views of the endoscopic tool
  • levers 52 and 53 are shown in their fully open state in Figure 26 holding Endo clip
  • Figure 27 shows the wedge driver 55 advanced forward pushing levers
  • Figure 28 is a sectioned perspective view of an alternative embodiment of a clip assembly 100 which substitutes the lower, deep (distal) penetrating elements or teeth with rounded approximating elements, such as bars 102 configured to engage tissue such as mucosal tissue.
  • Like elements relative to other embodiments are referred to with like reference numerals in Figures 28 and 29.
  • the operation of clip assembly 1 00 may be the same as described previously.
  • Bars 102 may have various forms and may have a roughened surface or slight projections for engaging the tissue 104 with additional friction.
  • Figure 29 is a cross sectional view of the clip assembly 100 shown in
  • Figure 28 engaged with mucosal tissue 104 after removal of, for example, a polyp (not shown).
  • this device could be used for large trauma wounds which need layered closure. While this invention is not limited to the removal of skin lesions, this represents one of the largest volume procedures requiring acute wound closure.
  • the wound closure device could be incorporated into another medical device such as the trocar assembly or other access device.
  • tissue approximating elements may take many forms, such as the penetrating teeth, flat compression bars, or still other forms as necessitated or desired due to the application needs. Also, depending on the application, these approximating elements may move independent of each other or together from the open to the closed condition.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Ensemble pinces (10) et procédé de rapprochement des berges d'une plaie dans un tissu, l'ensemble pince comprenant une première pince (14) et une seconde pince (13). La première pince (14) et la seconde pince (13) comprennent chacune une structure de rapprochement de tissu (21, 22), par exemple, des éléments pénétrant dans le tissu et/ou des éléments ne pénétrant pas dans le tissu. Ces éléments sont mobiles et peuvent passer d'un état ouvert pour recevoir le tissu adjacent à la plaie à un état fermé dans lequel les éléments (21, 22) ou autre structure de rapprochement de tissu s'insèrent dans le tissu quand les pinces referment la plaie. Généralement, les première et seconde pinces (14, 13) sont adjacentes et la structure de rapprochement de tissu (22) de la première pince (14) est conçue pour s'insérer dans une première partie du tissu, tandis que la structure de rapprochement de tissu (21) de la seconde pince (13) est conçue pour s'insérer dans une seconde partie du tissu, en une position proximale à la première quand elle passe de l'état ouvert à l'état fermé. Une structure de raccordement (15) raccorde les première et seconde pinces (14, 13) ensemble de manière à permettre le mouvement entre les états ouvert et fermé.
PCT/US2010/058321 2009-11-30 2010-11-30 Ensemble pinces et procédé de rapprochement des berges d'une plaie dans un tissu Ceased WO2011066533A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26499809P 2009-11-30 2009-11-30
US61/264,998 2009-11-30

Publications (1)

Publication Number Publication Date
WO2011066533A1 true WO2011066533A1 (fr) 2011-06-03

Family

ID=44066948

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/058321 Ceased WO2011066533A1 (fr) 2009-11-30 2010-11-30 Ensemble pinces et procédé de rapprochement des berges d'une plaie dans un tissu

Country Status (1)

Country Link
WO (1) WO2011066533A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9375218B2 (en) 2006-05-03 2016-06-28 Datascope Corp. Systems and methods of tissue closure
JP2019531150A (ja) * 2016-10-14 2019-10-31 ユニバーシティ・カレッジ・ダブリン，ナショナル・ユニバーシティ・オブ・アイルランド，ダブリン 組織アンカー
JP2019198652A (ja) * 2018-05-18 2019-11-21 ユーカテック・アクチェンゲゼルシャフトＥｕｃａｔｅｃｈ ＡＧ 管状編みステント
US10485545B2 (en) 2013-11-19 2019-11-26 Datascope Corp. Fastener applicator with interlock
EP3721816A3 (fr) * 2015-04-02 2020-12-16 Abbott Cardiovascular Systems, Inc. Dispositifs améliorés pour la fixation de tissu
US11653928B2 (en) 2018-03-28 2023-05-23 Datascope Corp. Device for atrial appendage exclusion
CN116367878A (zh) * 2020-09-28 2023-06-30 拉奇医疗有限公司 微针贴片施用系统

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030126744A1 (en) * 2002-01-08 2003-07-10 Lau Tung Yan Multi-positionable hair trimmer
US20070021779A1 (en) * 2003-06-27 2007-01-25 Garvin Dennis D Device for surgical repair, closure, and reconstruction
US20070142853A1 (en) * 2005-12-21 2007-06-21 The Cleveland Clinic Foundation Apparatus and method for excising tissue and bandaging the resulting wound
US20080172885A1 (en) * 2006-12-22 2008-07-24 Matsushita Electric Works, Ltd. Hair clipper
US20080249549A1 (en) * 2001-10-01 2008-10-09 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080249549A1 (en) * 2001-10-01 2008-10-09 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
US20030126744A1 (en) * 2002-01-08 2003-07-10 Lau Tung Yan Multi-positionable hair trimmer
US20070021779A1 (en) * 2003-06-27 2007-01-25 Garvin Dennis D Device for surgical repair, closure, and reconstruction
US20070142853A1 (en) * 2005-12-21 2007-06-21 The Cleveland Clinic Foundation Apparatus and method for excising tissue and bandaging the resulting wound
US20080172885A1 (en) * 2006-12-22 2008-07-24 Matsushita Electric Works, Ltd. Hair clipper

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10595861B2 (en) 2006-05-03 2020-03-24 Datascope Corp. Systems and methods of tissue closure
US11992211B2 (en) 2006-05-03 2024-05-28 Datascope Corp. Systems and methods of tissue closure
US9375218B2 (en) 2006-05-03 2016-06-28 Datascope Corp. Systems and methods of tissue closure
US11369374B2 (en) 2006-05-03 2022-06-28 Datascope Corp. Systems and methods of tissue closure
US11564689B2 (en) 2013-11-19 2023-01-31 Datascope Corp. Fastener applicator with interlock
US10485545B2 (en) 2013-11-19 2019-11-26 Datascope Corp. Fastener applicator with interlock
US12396729B2 (en) 2013-11-19 2025-08-26 Datascope Corporation Fastener applicator with interlock
EP3721816A3 (fr) * 2015-04-02 2020-12-16 Abbott Cardiovascular Systems, Inc. Dispositifs améliorés pour la fixation de tissu
US10893941B2 (en) 2015-04-02 2021-01-19 Abbott Cardiovascular Systems, Inc. Tissue fixation devices and methods
US12178443B2 (en) 2015-04-02 2024-12-31 Abbott Cardiovascular Systems, Inc. Tissue fixation devices and methods
JP7383284B2 (ja) 2016-10-14 2023-11-20 ユニバーシティ・カレッジ・ダブリン，ナショナル・ユニバーシティ・オブ・アイルランド，ダブリン 組織アンカー
JP2019531150A (ja) * 2016-10-14 2019-10-31 ユニバーシティ・カレッジ・ダブリン，ナショナル・ユニバーシティ・オブ・アイルランド，ダブリン 組織アンカー
US11653928B2 (en) 2018-03-28 2023-05-23 Datascope Corp. Device for atrial appendage exclusion
JP2019198652A (ja) * 2018-05-18 2019-11-21 ユーカテック・アクチェンゲゼルシャフトＥｕｃａｔｅｃｈ ＡＧ 管状編みステント
CN116367878A (zh) * 2020-09-28 2023-06-30 拉奇医疗有限公司 微针贴片施用系统
JP2023543947A (ja) * 2020-09-28 2023-10-18 ラッチ メディカル リミテッド マイクロニードルパッチ適用システム

Similar Documents

Publication Publication Date Title
RU2318458C2 (ru) Способ сшивания телесной ткани
US10507019B2 (en) Surgical device for advancing a surgical knot
US8777988B2 (en) Methods for using self-retaining sutures in endoscopic procedures
US11123059B2 (en) Vascular hole closure delivery device
US7087060B2 (en) Methods for obtaining hemostasis of percutaneous wounds
WO2011066533A1 (fr) Ensemble pinces et procédé de rapprochement des berges d'une plaie dans un tissu
EP3402416A1 (fr) Dispositif de fixation de tissu intra-dermique
DE29914859U1 (de) Anoskop
US20220280193A1 (en) Causing ischemia in tumors
US20120053603A1 (en) Wound closure clips, systems and methods
Naimer et al. The subcutaneous loop: a single suture technique for skin closure after superficial and subcutaneous surgery

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10834026

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 10834026

Country of ref document: EP

Kind code of ref document: A1