CN104203123A - Implant for hernia repair - Google Patents

Implant for hernia repair Download PDF

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Publication number
CN104203123A
CN104203123A CN201380009251.XA CN201380009251A CN104203123A CN 104203123 A CN104203123 A CN 104203123A CN 201380009251 A CN201380009251 A CN 201380009251A CN 104203123 A CN104203123 A CN 104203123A
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CN
China
Prior art keywords
layer
ground floor
implant
net
described ground
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.)
Pending
Application number
CN201380009251.XA
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Chinese (zh)
Inventor
S.G.贝尔
G.阿马托
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.)
Insightra Medical Inc
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Insightra Medical Inc
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Filing date
Publication date
Priority claimed from US13/443,266 external-priority patent/US20120209301A1/en
Application filed by Insightra Medical Inc filed Critical Insightra Medical Inc
Publication of CN104203123A publication Critical patent/CN104203123A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/30Surgical drapes for surgery through the lower body openings, e.g. urology, gynaecology
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B17/06109Big needles, either gripped by hand or connectable to a handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00349Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072Delivery tools therefor
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04CROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00Control; Monitoring or safety arrangements
    • F04C2270/04Force
    • F04C2270/042Force radial
    • F04C2270/0421Controlled or regulated

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Prostheses (AREA)

Abstract

A hernia repair implant (26) includes a first layer (58) made of mesh for facing a body structure having a hernia defect to cover the defect while promoting tissue growth into the first layer from the body structure. The implant also includes a second layer (60) opposed to the first layer and that extends radially beyond the first layer. The second layer is made of anti-adhesion material to prevent tissue growth into the second layer from body structures contacting it. The implant also includes a first elongated centering strap (34) connected to the first layer at a first radial location that extends radially beyond a periphery of the first layer, and a first elongated fixation strap (40) connected to the first layer at a second radial location that is more distanced from a center of the first layer than the first radial location and that extends radially beyond a periphery of the first layer.

Description

The implant of repairing for hernia
Technical field
The present invention relates generally to the repairing of the defect in myoarchitecture, and relates more specifically to be devoted to the implant of (address) abdominal hernia, inguinal hernia, and implant is less before moves up into the method in patient body intrusively for making.
Background technology
Patent announcement cited above discloses a kind of surgical implant, and its band has or not tension force and without fixing implant net, and this surgical implant has from implant net outward extending a plurality of band radially.Band pulls implant net is fixed on stomach wall via abdomen (abdominal part) wall musculature, makes when implanting, and implant net is under the relaxed state with respect to stomach wall.Implant net is sized to and is roughly greater than hernia.For example, in order to allow tissue inwardly to grow into networking and prevent that the structure (, intestinal) in peritoneum space from inwardly growing in net from stomach wall simultaneously unexpectedly, mesh liner has anti-adhesive layer or material.Non-sticky net can be used in preperitoneal space.
Although it is effective that the structure in patent announcement cited above proves, but present principles is understood be to stomach wall (net) layer can due to tissue ingrowth the past along with the time shrink, and anti-stick closing (peritoneum space) layer can be not like this, this can cause implant bunchy.In addition, present principles is recognized, can provide even better implant compliance to reduce patient's discomfort.
Present principles is devoted to be convenient to centering of large implant, and large implant moves forward by laparoscopic trocar with respect to hernia defect.This is challenging because net must roll as thick cigar shape pattern so that its by the narrow sleeve pipe reach in sleeve pipe, launch and be suitably positioned on hernia with rear center ground.
Summary of the invention
Among other advantage, it is useful that the reducing of the net quality realizing with the implant design of emphasizing herein proves in implant is carried by trocar cannula.
Therefore, in one embodiment, hernia is repaired implant and is comprised the ground floor of being made by net, and it to cover this defect, promotes that tissue grows into ground floor from body structure in the face of having the body structure of hernia defect simultaneously.Implant also comprises the second layer relative with ground floor, and the second layer is made by anti-stick condensation material, and to prevent that tissue from growing into the second layer from the body structure contacting with the second layer, the second layer is understood to radially extend beyond ground floor.In addition, implant has at least the first microscler band that centers being connected on ground floor, and it is connected on ground floor in the first radial position place.In addition, implant comprises at least the first microscler fixing band being connected on ground floor, and it is connected on ground floor in the second radial position place, and the second radial position is more farther from the center of ground floor than the first radial position.
If expectation, the net of implant can limiting hole size.Ground floor can be continuous stratum reticulare, is that it does not have the opening larger than hole dimension, or it can be skeleton stratum reticulare, defines periphery and defines at least one the larger opening of ratio hole dimension within periphery.Note, bone portion can fully interrupt, and Wang island can be leaned against on anti-adhesive layer.
In addition, in certain embodiments, implant is also included in the spacer structures between ground floor and the second layer, makes spacer structures that ground floor and the second layer are separated.Spacer structures can comprise knot and/or a ball of at least one circle.Or it can set up spiral in shape, or it can comprise and defines separately the one or more hollow components that surround completely.Again again, spacer structures can comprise a plurality of puffed rice elements, and it can be lobe shape, and with the stem of contiguous juxtaposed lobe each other and the end of lobe away from each other radially, and/or structure can be set up by any combination of aforementioned feature.
On the other hand, hernia is repaired implant and is comprised the ground floor of being made by net, and it to cover this defect, promotes that tissue grows into ground floor from body structure in the face of having the body structure of hernia defect simultaneously.Implant also comprises the second layer relative with ground floor and that made by anti-stick condensation material, to prevent that the body structure that tissue contacts with the second layer from growing in the second layer.In addition, implant has structure, this structure not between ground floor and the second layer so that the spaced flat continuous level of layer, the structure that causes combination is dynamic and compressible, to stimulate tissue to come inwardly to grow better via the physiology load circulating.
Another aspect, a kind of method comprises makes implant move up in patient body before by a near otch part for the muscular wall to be repaired by the trocar.Implant comprises and is connected to the online band and be connected to the online fixing band in the outside of the position that the band that centers is connected to of centering.The method also comprises that the band reach of making to center is by muscular wall, with by net with respect to the defect part in muscular wall be deployed in the position at center.The method comprises subsequently makes fixing band reach complete fixing on muscular wall of net by muscular wall.By the band that centers, by suture or other tacked constructions, net is centered on defect, and only use center is brought net is centered, center band is also fixed to net on wall.Than the core of net is sewn in defect or near defect, this has advantageously eliminated independent stitching step, and allows the manipulation of the improvement when net is centered.
On the other hand, hernia is repaired implant and is had the ground floor of being made by net, in the face of having the body structure of hernia defect, to cover this defect, promotes that tissue grows into ground floor from body structure simultaneously.The second layer is relative with ground floor, and is made by anti-stick condensation material, to prevent that tissue from growing into the second layer from the body structure contacting with the second layer.Net defines hole dimension, and ground floor is skeleton stratum reticulare, defines periphery and defines at least one the larger opening of ratio hole dimension within periphery.
Accompanying drawing explanation
Details about structure of the present invention and operation all can be understood best with reference to accompanying drawing, and therein, identical reference number represents identical parts, and in the accompanying drawings:
Figure 1A is the viewgraph of cross-section of the abdominal section of front stomach wall;
Figure 1B is the viewgraph of cross-section of Figure 1A, and the hernia showing in stomach wall forms (herniation);
Fig. 2 to Fig. 5 is schematic diagram, illustrates the implant with the net of the band that centers;
Fig. 6 is the plan view of the example net shown in Fig. 2 to Fig. 5, and it is configured for suitably abdominal hernia and repairs, and shows four center band and seven fixing bands;
Fig. 7 is the plan view that is configured for the alternative net of inguinal canal hernia repairing;
Fig. 8 to Figure 11 is the plan view of the various embodiment of skeleton net, and skeleton net flushes against anti-adhesive layer, with the anti-adhesive layer that radially extends beyond skeleton net, to guarantee that not organizing in peritoneum space can grow in networking at the edge of anti-adhesive layer around;
Figure 12 is the top perspective along the skeleton net at those lines shown in Fig. 8 to Figure 11, with center band and the fixing band of the line along the embodiment shown in Fig. 6;
Figure 13 is schematic side elevation, illustrate the implant made from the relative compressible structure between anti-adhesive side layer by getting involved the first stratum reticulare, anti-adhesive side layer comprises against the second net of compressible structure and anti-bonding sheet location, what understand is, in certain embodiments, anti-bonding sheet can omit and the second net is made by anti-stick condensation material;
Figure 14 is the top plan view of the example embodiment of the implant net similar with the implant net shown in Figure 13, with the spiral relative compressible structure occurring through the first stratum reticulare;
Figure 15 is the perspective view of the implant shown in Figure 14;
Figure 16 to Figure 18 is the top perspective with the implant of the alternative relative compressible structure in inside, and a stratum reticulare is folding away from another stratum reticulare, so that the structure of relative compressible structure to be shown better;
Figure 19 and Figure 20 are respectively front view and the perspective view of " island " type skeleton net, and Figure 20 has omitted the band that centers in order to know; And
Figure 21 is for being with the perspective view of the instrument of fetching.
The specific embodiment
First, although will be appreciated that the repairing of mentioning especially in this article abdominal hernia, the apparatus and method of describing in this article can be used for other surgery or laparoscopic procedure, such as but not limited to other situation that wherein organizational structure of human body need to be strengthened or support.In addition,, although shown in the abdominal section of stomach wall and be however described as the treatment for abdominal hernia, the apparatus and method of describing in this article can be used for other program and the region of inguinal hernia, pelvic support and health.
Now first with reference to Figure 1A, show the viewgraph of cross-section of normal, front stomach wall of the abdomen area of health.As shown, stomach wall comprises left rectus 10 and the right rectus 12 that is surrounded and be held in place by the rear layer of fascia 14 and the anterior layer of fascia 16.As thin, strong fibrous tissue, these fascia layers combine in the region in the middle of rectus 10 and 12.The thin layer 18 that is called as peritoneum has covered the rear side of rear fascia 12.Soft, the pliable and tough layer that peritoneum 18 is organization material, and provide encirclement for intestinal and other internal organs.The layer of the skin consisting of lower corium 20 and corium 22 has covered the outside of front fascia 16.Figure 1B illustrates the situation that wherein hernia has formed in the wall of abdominal part.Hernia opening illustrates with 24.In this example, the fascia layer 14 of hernia in the region in the middle of rectus 10 and 12 and 16 break and form.Note, internal organs projection not only can occur, but also can on the lateral face of stomach wall, occur on center line.In the case, the outstanding sidewall musculature being formed by outside and inner oblique and transversus of crossing of internal organs.In any case, break and allow internal organs in outside direction, to promote peritoneum 18, produced the protuberance (bulge) 24 in skin layer 20 and 22.If not treatment, situation only can worsen along with the past of time, and peritoneum protuberance becomes larger.
With reference now to Fig. 2 to Fig. 5,, show schematic diagram, these schematic illustration with the implantation of net of the band that centers.Will be appreciated that following figure is combined to illustrate method step with equipment disclosed herein conventionally.Particularly, Fig. 2 to Fig. 5 moves up in patient body before showing and making implant by a near otch part for the muscular wall to be repaired with suitable medical device.As shown below and describe, implant comprises and is connected to the online band that centers, and the fixing band that is connected to the net in the outside of being with the position being connected to of centering.In other words, center band than the geometric center of the more approaching net of fixing band, be connected on the net.Therefore, the band reach of centering is by muscular wall, with by mesh portions be deployed in the center with respect to the defect in muscular wall, and fixing band moves forward subsequently by muscular wall, to complete fixing to muscular wall of net.
With the band that centers, do not use suture (suture) or other to mark closely (tacking) structure net is centered on defect, and only use, also net is fixed to centering on wall and brings net is centered.Than the core of net is sewn in defect or near defect, this has advantageously eliminated independent stitching step, and further allow the manipulation of the improvement when net is centered, because center, band allows surgeon to pass through as required laterally mobile network, net is centered, by being with volume (cinch) Dao Wang center as required, net is centered.
In addition, attention, net described herein (the skeleton mesh portions and the guipure described herein that comprise implant described herein) can be built by solid or permeable material, makes them can receive tissue ingrowth.For the suitable material of making net, can include but not limited to following: polypropylene net, such as the C. R. Bard Inc. by New Jersey Murray Hill with " Marlex " trade mark distribution; Polythene net material by the E. I. DuPont de Nemours and Company of Delaware State Wilmington with the type of " Alathon " trade mark distribution; Terylene net materials or nylon wire material by the type of the E. I. DuPont de Nemours and Company distribution of Delaware State Wilmington; Teflon; And silicones.
In addition,, if expectation, net described herein can build from having the wire netting wiry or the polymeric web that interweave.These can provide additional intensity to net, or to make net be radiopaque for after a while visual.Net can be monolayer or has multi-ply construction.Net can have one or more layers structure by bioabsorbable material, and net can be absorbed by health along with the past of time again.
Now particularly about Fig. 2; what can understand is; implant 26 for example, moves up in patient body before having used suitable armarium 28 (, as, the trocar and/or protectiveness sheath); for example; by the otch on hernia to be repaired 30 sides, will be appreciated that with equipment 28 and (for example compress as shown in Figure 2 implant 26; in cigar shape mode, roll), to allow favourable reach.Implant therefore can before move up in patient body, for example, use laparoscopic technique and 30 reaches of the hernia in stomach wall via abdominal cavity 32.Hernia 30 have about/be similar to the characteristic of hernia opening 24 described above.Can understand from Fig. 2, implant 26 can comprise that a plurality of centering be with 34.
If expectation, centers and be with 34 can first before move up in patient body, and after before moving up at least in part in the patient body with hernia 30 with 34, the remainder of implant is carried via for example trocar and sheath.First, before making to be with 34 reaches can make to be with 34 more uncomplicated ground, move up in stomach wall 38, because in the time of for example carry out performing a programme and anchor to center with 34, implant 26 to be placed in the orientation of expectation according to present principles on, the remainder of implant 26 more unlikely hinders and covers surgical sight line.
As can be from understanding to upward arrow 36 as shown in Fig. 2, center and be with 34 before to move up in stomach wall 38 at least in part, and preferably, center and be with 36 fully reaches to pass through stomach wall, they are outwards moved forward by having the patient's of hernia 30 skin, comprise that reach is by lower corium and corium.This case continues for being incorporated to above the part of female case patent application of patent, female case Patent Application Publication for carrying out the various technology of this operation.Therefore, what can understand from Fig. 3 is, center and be with 34 to be arranged at least in part in stomach wall 38, and owing to radially moving up in stomach wall 38 before the position away from hernia 30 self, therefore guarantee at least in part not have to move up in hernia 30 on another part of too much net or implant 26 with 34.In addition, be with 34 to prevent that implant 26 is sagging when for example discharging pneumoperitoneum in front moving up into stomach wall 38 time, and therefore, it has eliminated the potentiality of the recurrent chance of hernia and seroma at least in part.As also understood from Fig. 3, equipment 28 is regained from the region of hernia 30, allows implant 26 to start to expand, launch, dispose and/or take the shape being intended to cover the defect in stomach wall 38 being caused by hernia 30, and is convenient to tissue and grows according to present principles.
Because Fig. 3 shows the implant 26 that slave unit 28 is fully removed, can understand, a plurality of fixing bands 40 are also obvious in implant 26.To fixing band 40 be described with further reference to Fig. 5.But first, attention, as shown in Figure 4, implant 26 is shown at least in part and covers/stop/cover the hernia 30 in stomach wall 38, understand the shape of having taked at least in part it to be intended in the hernia 26 shown in the structure of Fig. 4.
With reference now to Fig. 5,, can understand, fixing band 40 before moves up in stomach wall 38 now at least in part.If expectation, fixing band 40 can fully move forward by stomach wall 38, makes their reaches by the skin of the patient with hernia 30.What from Fig. 5, can further understand is, the side surfaces of implant 26 is arranged against stomach wall 38 now, fully to cover hernia 30, thereby be convenient to the tissue growth according to principle described herein, due to the visceral surface (it can have the anti-adhesion characteristic as set forth herein) of implant 26, also favourable ground resistance block material body, fluid, organ, tissue etc. are at least in part through hernia 30 simultaneously.
What note is, center with 34 and fixing band 40 in any one or both can by with 34 and 40 and wall 38 between frictional force come affixedly to enter in stomach wall 38, to reduce to greatest extent patient's discomfort, still guarantee that implant 26 remains in its location/orientation being intended to, and can within abdominal cavity 32, not shift simultaneously.This provides relatively tension-free anchor means, also eliminated simultaneously and used other to mark closely the needs of method, these other mark closely the potential point that method can otherwise provide bonding and/or tension force during patient's healing process, for example, because patient is uncomfortable, this is unexpected.Owing to being organized in wall 38 healing and when being incorporated to tissue and invading implant 26 along with the time changes, therefore elimination suture or other equipment for fastening also make implant move along with the expansion of surrounding tissue or contraction, as a part for healing process.In essence, only by band frictional force, come affixed implant to hold better movement of tissue and/or expansion.Yet, if think necessaryly, still can use additional fixed form, such as but not limited to marking closely, suture, securing member and fixture.
Although like this above, what can understand is, only use the attached frictional force means of stomach wall that relatively tension-free state is provided, implant 26 affixed entering in its position fully loosely wherein, when making when surrounding tissue expansion or moving, implant is lax assists to avoid the pulling of surrounding tissue and possible tearing, otherwise can cause the pulling of surrounding tissue and possible tearing by implant affixed or that do not have any residue lax (for example, owing to marking closely or fixture) too tightly.Therefore, can understand, rely on stomach wall 38 and with the frictional force producing between 34 and 40, be with 34 and 40 affixed implants 26 and make implant 26 stable, also allow with 34 and 40 movements along with the aspiration level in the past of time with respect to surrounding tissue simultaneously.Relatively tension-free with 34 and 40 and the structure that fully covered the implant 26 of hernia 30 provide sizable lax, allow long-term natural stomach wall to reinvent and make, this has shown and has been considered to for reducing and the fixing principle of hernia particular importance.What will be appreciated that this type can promote better healing without tension force and without fixing implant, reduces and tears too early or be shifted or dislocate, and the patient's comfortableness and the acceptance that improve are provided.
Still be devoted to be with 34 and 40, what note is, although shown in Fig. 2 to Fig. 5 is to be attached in implant 26 while moving up in the patient body with hernia 30 before being shown in 34 and 40, but in other embodiments, implant 26 can with on not being attached to it, be with 34 to move up in abdominal cavity 32 before together with 40.Therefore, be with 34 and 40 can before move up at least in part in stomach wall 38, from implant 26, do not depart from simultaneously, and then connect subsequently/be attached in implant 26.Alternatively or with the combination of any expectation, implant 26 can not be attached be with 34 and 40 and before move up in abdominal cavity 32, and then subsequently, before moving up in stomach wall 38 before being with 34 and 40, band can be attached in implant 26.What can understand is, what can expect is not to be attached with 34 and 40 to make before implant 26 to move up into the advantage in abdominal cavity 32, for following reason, such as but not limited to: (for example easily make to move up into before implant 26 in patient body, if implant is relatively large and be difficult to settle and enter or handle with equipment 28) and easily implant 26 is placed against stomach wall 28, to cover thus hernia 30.
Continue reference tape 34 and 40, band can be made by the net as polypropylene net, and this is convenient to the tissue growth according to present principles.If expectation, can be made by the combination of any other suitable synthetic material, biomaterial or material with 34 and 40.In any case, will be appreciated that, further be convenient to be with 34 and 40 before to move up at least in part in stomach wall 38, with 34 and 40 needles (not shown in Fig. 2 to Fig. 5) of corresponding engaged at end that can comprise with band, so that move up in stomach wall 38 before being with 34 and 40.In certain embodiments, pin removably be with 34 and 40 to engage, make pin can be with 34 and 40 before move up into stomach wall at least in part in after be with 34 and 40 to depart from.
Also note, in certain embodiments, can before treating, to move up into end in stomach wall be taper with 34 and 40.This can be convenient to be with 34 and 40 reaches by various organizational structuries.Therefore the lateral profile, reducing can reduce friction and for example will pull or push required making a concerted effort in stomach wall 38 with 34 and 40.Note, can by polyethylene, polypropylene, Teflon, nylon, silicones or other suitable polymer, be made according to present principles with 34 and 40, these materials for 34 and 40, reduce friction during by organizing in stomach wall 38 can be useful.
Be devoted to now Fig. 6, show the plan view of example net implant, for example, be configured for suitably that abdominal hernia repairs in the example net implant shown in Fig. 2 to Fig. 5.Fig. 6 shows four of being attached in net implant 42 for non-limiting diagram object and centers and be with 44 and seven fixing bands 46.Will be appreciated that centers is with 44 can and texturally roughly be similar to described above centering and be with 34 in function, and fixing band 46 in Fig. 6 can be at function and the textural fixing band 40 that is roughly similar to previous description.Note, although Fig. 6 shows four, be with 44 and seven to be with 46, can use more or less band according to expectation.
In addition, can understand from Fig. 6, the body 48 of implant 42 can be substantially circle/radiation in shape, although the shape of any expectation all can make for covering fully hernia opening.Still, what note is, in showing Fig. 6 of circle/actiniform implant 42 substantially, center and be with 44 in radial position place, to be attached in implant 42, this radial position from the distance at the center of implant than fixing band 46 be attached to position in implant 42 from the distance at the center of implant more close to.
Continue, Fig. 7 shows the plan view of the alternative net implant that is configured for hernia repairing.The body 54 of the implant 50 shown in Fig. 7 is being substantially rectangle in shape, what again note is, in other embodiments, implant described herein can be any suitable geometry or non-geometry (for example, by internist, pruned especially and/or the shape of molding) and covers hernia opening.Fig. 7 also shows four fixing bands 52 that the corresponding corner away from body 54 extends diagonally.Will be appreciated that and be with 52 can described abovely be with 40 in function and textural being roughly similar to, and some differences are considered the difformity having given with the body of the appended corresponding implant of receiving.In addition, although it is not shown in Figure 7, if expectation centers, band also can be included in according on the body 54 of the implant 50 of present principles, what understand is, if comprise the band that centers, the band that centers can be in the position of making a farfetched comparison tape splicing 52 from body 54 center relatively the location of the body 54 close to be more attached on body 54.Also note, in example, disclosed herein be with 54 and other center band and fixing band in non-limiting example, can be two centimetres wide and ten centimeter length.In addition, attention, body 54 can be but is not limited to 15 centimetres of sizes of taking advantage of 15 centimetres, and other implant body disclosed herein is also like this.Yet, attention, the size and the length that are included in the one or more elements in implant described herein can be depending on the size of hernia to be repaired and change.
Pay close attention to now Fig. 8 to Figure 11, the plan view of the various embodiment that Fig. 8 to Figure 11 is the skeleton net that flushes with anti-adhesive layer, and anti-adhesive layer (for example radially extends beyond skeleton net in some instances, several centimetres), to guarantee that organizing in peritoneum space can not contact or become bonding and enter in net around the edge of anti-adhesive layer.Advantageously, skeleton netting gear has the quality that is less than continuous net, is convenient to net reach and passes through the trocar.Yet, because skeleton net provides for the abundance of tissue ingrowth but inexcessive space, therefore tissue growth to wherein but while not entering anti-adhesive layer unlikely collection hold together, as occurred when fully continuous ingrown net is attached on anti-adhesive layer.
In addition, the gap of being built up by example skeletal structure described below or island have guaranteed that scar tissue can not bridge joint, and have therefore avoided the unexpected overall length of netting between healing stage to shrink.The radial contraction that is grown into the net that the scar tissue in networking causes by this class is shunk the independence " island " of skeletal structure or mesh portions, but can not make to shrink the whole length of transmitting anti-adhesive layer.In the embodiment of Fig. 8 to Figure 12, the circumferential hoop of net is shown in the inner side (it also can be the ring of interruption) at the edge of anti-adhesive layer.This outer shroud provides ingrown ring, and ingrown ring prevents that the rising of implant and internal organs may be trapped in implant rear.
First with reference to figure 8, example implant 56 has the skeletal layer 58 of being made by net, and this net, in the face of having the body structure of hernia defect, to cover defect, promotes that tissue grows into skeletal layer from body structure simultaneously.Skeleton net 58 can be made by any suitable tissue ingrowth material, for example any in material described above.Implant 56 also has the second layer 60, and the second layer 60 is relative with skeletal layer 58.Will be appreciated that the second layer 60 made by anti-stick condensation material, to prevent that the non-tissue being intended to is from having contacted the abdominal cavity growth of the second layer and/or being incorporated to implant 56.
But as an example, the part with the implant 56 of skeletal layer 58 can and be set to alongside and/or against stomach wall, to cover the hernia opening in stomach wall, makes the second layer 60 in the face of patient's abdominal cavity.Therefore, rely on the anti-adhesion characteristic blocked any second layer contacting 60 between organ and skeletal layer 58, will prevent that organ (for example, patient's intestinal) and implant 56 from clinging, grow, snarling etc.
Therefore, can understand, anti-attaching components described herein and material stop tissue ingrowth or are attached in the part of the implant with anti-attaching components and/or character.Except thering is the second layer 60 of anti-adhesion characteristic, what note is, replace (for example thering is the second layer, layer 60 with anti-adhesion characteristic) implant or for example, except (thering is the second layer, layer 60 with anti-adhesion characteristic) outside implant, the other parts of implant described herein can be coated with anti-adhesive coatings (for example, in the face of away from stomach wall and in a side of stomach wall) according to expectation, attached to suppress thus to organize.In other words, can understand, anti-adhesion characteristic can be useful in particular for those implant surfaces that are exposed to the internal organs in abdominal cavity.One of anti-stick condensation material is exemplified as the Associates by W. L. Gore &, the line of the politef polymeric material of the type that Inc sells with the name of " Gore-Tex " trade mark.Other non-restrictive example comprises monolithic polypropylene, as Dipromed, PVDA film, silicones interlayer or biological net or bionical net.
Still with reference to figure 8, what can understand is, example net skeletal layer 58 has oval part 62 and " X " pattern part 64 substantially, the corresponding internal edge that " X " pattern part 64 extends to oval part 62 in oval 62 inside diagonally with respect to major axis and the minor axis of oval part 62.Also can understand from Fig. 8 (and from corresponding implant structure of the Fig. 9 to Figure 12), second (anti-stick closing) layer 60 radially extends beyond skeletal layer 58.Although " X " part 64 comprises two continuous bands intersected with each other, band does not need not continuous, and alternatively, " island " that be not connected to the net of going up each other can set up skeleton, tissue ingrowth layer.
Fig. 9 shows alternative skeletal structure, and it is for according to the layer of the implant of the stomach wall against the patient location of present principles.Implant 66 shown in Fig. 9 has the skeletal layer 68 of being made by net, and net is for facing the body structure with hernia defect.Implant 66 also has the second layer 70 relative with skeletal layer 68.Will be appreciated that the second layer 70 made by anti-stick condensation material according to present principles, to prevent the growth of tissue.
What note is, Fig. 9 shows net skeletal layer 68, it is comprised of oval part 72 and cross figure or plus sige pattern part 74 in oval part 72 inside substantially, and net extends to the respective inner edge of oval part 72 with respect to the major axis of oval part 72 in vertical and horizontal direction with minor axis.Also note, the second layer 70 radially extends beyond skeletal layer 68.
Figure 10 shows another alternative skeletal structure, and it is for according to the layer of the implant of the stomach wall against the patient location of present principles.Implant 76 shown in Figure 10 has the skeletal layer 78 of being made by net, and net is for facing the body structure with hernia defect.Implant 76 also has the second layer 80 relative with skeletal layer 78.Will be appreciated that according to present principles, the second layer 80 is made by anti-stick condensation material, to prevent the growth of tissue.
What note is, Figure 10 shows the skeletal layer 78 of being made by net, guipure has oval part 82 substantially and in the pattern of oval part 82 inside, four diagonal angle parts 86 that this pattern has central horizontal part 84 and extends diagonally away from two respective end of central horizontal part 84.Note, the description of the inside pattern of skeletal layer 78 is to carry out about the major axis of the oval part 82 of skeletal layer 78 and minor axis.Also note, the second layer 80 radially extends beyond skeletal layer 78.
Figure 11 shows another alternative skeletal structure, and it is for according to the layer of the implant of the stomach wall against the patient location of present principles.Implant 88 shown in Figure 11 has the skeletal layer 90 of being made by net, and net is for facing the body structure with hernia defect.Implant 88 also has the second layer 92 relative with skeletal layer 90.Will be appreciated that according to present principles, the second layer 92 is made by anti-stick condensation material, to prevent the growth of tissue.
Note, Figure 11 shows skeletal layer 90, and it is with oval part 94 and net horizontal component 96 substantially, and net horizontal component 96 extends and in the internal edge place of oval part 94 termination along the major axis of oval part 94.Also note, the second layer 92 radially extends beyond skeletal layer 90.
With reference now to Figure 12.Figure 12 shows the top perspective of hernia implant 98, with along those the skeleton net 100 of line shown in Fig. 8 to Figure 11, with the line along the embodiment shown in Fig. 6 microscler, center and is with 102 and microscler fixing band 104.Therefore, Figure 12 shows skeleton net 100, and it is with the second anti-adhesive layer 106 that radially extends beyond skeleton net 100.Can understand, skeleton net 100 is roughly similar to textural the skeletal layer 78 of describing with reference to Figure 10, although will be appreciated that any in other skeletal layer structure described herein can be used according to present principles.
Still, with reference to Figure 12, will understand, microscler centering is with 102 to be connected on skeleton net 100.In certain embodiments, with 102 peripheries that can radially extend beyond skeleton net 100, but in other embodiments, with 102 peripheries that do not need radially to extend beyond skeleton net 100, as long as their long enoughs before move up in patient's stomach wall at least in part according to expecting.In any case, attention be to center to be connected on skeleton net 100 with 102 the first radial positions place at the skeleton net 100 with respect to skeleton Wang100 center, after a while the second position will be described.
Also can understand from Figure 12, microscler fixing band 104 is connected on the skeleton net 100 of inner side, anti-adhesive layer edge.Due to band by the attachment point with them directly the stomach wall of conllinear arrive skeleton net, therefore the overlapping of anti-adhesive layer prevents that internal organs contact is to the carrying material exposing.In certain embodiments, with 104 peripheries that can radially extend beyond skeleton net 100, but in other embodiments, with 104 peripheries that do not need radially to extend beyond skeleton net 100, and be still sufficiently long, before to move up in patient's stomach wall at least in part according to expectation.In any case, attention be that fixing band 104 is connected on skeleton net 100 in the second radial position place of skeleton net 100, the second radial position is more farther from skeleton Wang100 center than the first radial position of describing in above paragraph.
Particularly with reference to skeleton net 100, attention be that skeleton net 100 defines hole dimension and at least one opening within periphery, this opening is greater than hole dimension (for example,, as can be understood from the skeleton of Fig. 8 to Figure 11).In addition, along the skeleton net 100 of the line of the skeletal layer of Fig. 8 to Figure 11, be understood to be in the net of being made by polypropylene in example embodiment, but can for example, by other suitable synthetic material, biomaterial or combined material (those that, above describe), be made.
Continue, with reference now to Figure 13, it is schematic side elevation, illustrate implant 108, this implant 108 is made by compressible (preferably, the plasticity) structure 116 between the first stratum reticulare 110 and the second stratum reticulare 112, and this structure 116 flushes against the second stratum reticulare 112.Also show the anti-adhesive side layer 114 according to present principles.Yet, will be appreciated that in certain embodiments, anti-bonding sheet 114 can omit, and anti-stick condensation material be made and/or be coated with at least in part to the second net 112 can by anti-stick condensation material.
In addition, can understand from Figure 13, structure 116 is the flat continuous level between the first net 110 and the second net 112, and can be used as in certain embodiments power/shock absorber, provides in implant 108 and hernia region elasticity around.Therefore, structure 116 is spaced apart from each other net 110 and net 112, so that tissue ingrowth enters in implant.In the example embodiment shown in Figure 13, structure 116 comprises a plurality of circular knots, with the white space between knot, and with the relative flat part of the rounded ends with knot, to make thus johning knot structurally, in other words, corrugated structures.Will be appreciated that and can use in other embodiments other structure, for example, a plurality of balls, these balls at least comprise the compressible structure between two nets 110 and 112.Also can use the rib of being made by net.
Turn to now Figure 14, show the top plan view of the example embodiment of implant net 118, this implant net 118 is similar to the implant net shown in Figure 13, except having spiral type compressible structure 120 (and non-circular knot) of occurring by the first stratum reticulare 122 according to present principles.The spiral in shape of structure 120 also can understand from the perspective view of the implant 118 shown in Figure 15.
With reference now to Figure 16 to Figure 18,, they be have alternative compressible structure according to the top perspective of the implant of present principles.Note, Figure 16 to Figure 18 shows away from a folding stratum reticulare of another stratum reticulare, so that the structure of the corresponding construction of figure to be shown better.
Describe Figure 16, can understand, implant 124 comprises the first stratum reticulare 126 and the second stratum reticulare 128.Figure 16 also shows structure 129, and structure 129 comprises and defines separately completely a plurality of hollow components that surround.If expectation, the hollow component of structure 129 can be ring-type and/or cylindrical, with inside circular core substantially, and this inside at least one circular net substantially that circular core supporting extends outwardly from it substantially.
Describe Figure 17, can understand, implant 130 comprises the first stratum reticulare 132 and the second stratum reticulare 134.Figure 17 also shows compressible structure 136, and it comprises a plurality of puffed rice elements, and they can have as directed different " puffed rice " structure.For example, puffed rice structure can be substantially similar to abstract paper folding shape, can be similar to shape and the modification of puffed rice, can form to comprise spherical shape etc. by various overlapping circular bars.
Describe Figure 18, can understand, implant 138 comprises the first stratum reticulare 140 and the second stratum reticulare 142.Figure 18 also shows compressible structure 144, and it is for lobe shape and comprise the contiguous stem 146 of juxtaposed lobe each other, and the end 148 of the lobe of radially opening from the Center Gap of implant 138.
Figure 19 and Figure 20 show skeleton-type net 200, skeleton-type net 200 comprises anti-adhesive layer 202, anti-adhesive layer 202 has supported the island formula skeleton net 204 consisting of tissue ingrowth Wang island, tissue ingrowth Wang island does not contact on being arranged on total anti-adhesive layer each other,, at least some in tissue ingrowth promotion island do not promote structure to be connected on another tissue ingrowth island by tissue ingrowth, although all parts of net 204 all can be bearing on anti-adhesive layer 202.Note, Figure 20 Zhong island forms in the outer stopping ring on slightly microscler island and three interior interrupt lines.Fixing band 206 rises on outer shroud Zhong Cong island; Also can use the band that centers according to above description, the band that centers is connected in some in lagoon island.
Figure 21 shows example band and fetches instrument 300, and it is with microscler rigidity plastics handle 302 and thumb recess 304, and microscler rigidity plastics handle 302 and thumb recess 304 are configured for receiving surgical thumb for grasping object.As shown, the almost semicircular metal retriever 306 tips ground of elongate curved extend away from handle 302, termination in seam or eye 308, above discussion center or fixing band in one can be by this seam or eye 308, to make thus retriever 306 engage with being with.When using open surgical procedures, retriever 306 moves up into before via subcutaneous tissue and Musclar layer and in patient body, enters peritoneum, and in laparoscopically surgical operation, retriever 306 moves up in patient body through before skin ground.Surgeon makes band engage with eye 308, and pulls backward instrument 300 by the various tissues shown in Figure 19, with the patient outside that extends to as illustrated to bring.Subsequently, band can be pruned and organize outwardly and to hide (tented), and band is slid back in tissue, keeps contacting with tissue next for by the fixing object of frictional force.
Can understand above based on all now, implant described herein can be fabricated to compare with the size of hernia relatively excessive.Any this type of relatively larger implant all can improve the bonding of itself and stomach wall.In certain embodiments, be sized to 1.5 times of area that the implant larger than hernia can be hernia, or be the twice of the area of hernia.
Also can understand, the anti-stick portion of implant described herein can radially extend across polypropylene net element, is convenient to tissue ingrowth, makes organ for example there is no the risk of contact net element.In addition, implant can be and can prune, once make to move up into before implant in patient body but be placed in against before the desired locations place of stomach wall in implant, implant can be pruned in abdominal cavity time.The composition of implant (at least a portion is made by for example polypropylene) allows this type of pruning.Pruning can be favourable, to make implant be shaped according to present principles, to meet uniquely hernia and/or to cover uniquely hernia.
Although illustrate and describe in detail the concrete implant of repairing for hernia herein, will be appreciated that the theme of being contained by the present invention is only limited by claims.

Claims (21)

1. hernia is repaired implant, and it comprises:
The ground floor of being made by net (58) in the face of having the body structure of hernia defect, to cover described defect, promotes that tissue grows into described ground floor from described body structure simultaneously;
The second layer relative with described ground floor and that made by anti-stick condensation material (60), to prevent that tissue from growing into the described second layer from the body structure contacting with the described second layer; And
In the first radial position place, connect at least the first microscler fixing band (40) on described ground floor, wherein, the described second layer radially extends beyond described ground floor.
2. implant according to claim 1, be included in the second radial position place and be connected at least the first microscler band (34) that centers on described ground floor, described the first radial position that described the second radial position connects than described fixing band from the center of described ground floor more close to.
3. implant according to claim 1, wherein, described net defines hole dimension, and described ground floor is continuous stratum reticulare, is that it does not have the opening larger than described hole dimension.
4. implant according to claim 1, wherein, described net defines hole dimension, and described ground floor is skeleton stratum reticulare, defines periphery and defines at least one larger opening of hole dimension described in the ratio within described periphery.
5. implant according to claim 4, wherein, described skeleton stratum reticulare comprises at least Liang Ge island that is not promoted structure net connected to one another by tissue ingrowth.
6. implant according to claim 1, wherein, described implant is also included at least one spacer structures (116) between described ground floor and the described second layer, make described spacer structures (116) that described ground floor and the described second layer are separated, wherein, described structure comprises at least circular knot and/or ball.
7. implant according to claim 1, wherein, described implant is also included at least one spacer structures (120) between described ground floor and the described second layer, make described spacer structures (120) that described ground floor and the described second layer are separated, wherein, described structure has been set up spiral in shape.
8. implant according to claim 1, wherein, described implant is also included at least one spacer structures (129) between described ground floor and the described second layer, make described spacer structures (129) that described ground floor and the described second layer are separated, wherein, described structure comprises and defines separately completely a plurality of hollow components that surround.
9. implant according to claim 1, wherein, described implant is also included at least one spacer structures (136) between described ground floor and the described second layer, make described spacer structures (136) that described ground floor and the described second layer are separated, wherein, described structure comprises a plurality of puffed rice elements.
10. implant according to claim 1, wherein, described implant is also included at least one spacer structures (144) between described ground floor and the described second layer, make described spacer structures (144) that described ground floor and the described second layer are separated, wherein, described structure is lobe shape, and comprises the stem of contiguous juxtaposed lobe each other and the end of the lobe that radially separates.
11. hernias are repaired implant, and it comprises:
The ground floor of being made by net (58), it to cover described defect, promotes that tissue grows into described ground floor from described body structure in the face of having the body structure of hernia defect simultaneously;
The second layer relative with described ground floor and that made by anti-stick condensation material (60), to prevent that tissue from growing into the described second layer from the body structure contacting with the described second layer; And
Structure, it is the flat continuous level between described ground floor and the described second layer not, so that described layer spaced and be convenient to tissue ingrowth and enter in described implant.
12. implants according to claim 11, wherein, described net defines hole dimension, and described ground floor is continuous stratum reticulare, is that it does not have the opening larger than described hole dimension.
13. implants according to claim 11, wherein, described net defines hole dimension, and described ground floor is skeleton stratum reticulare, defines periphery and defines at least one larger opening of hole dimension described in the ratio within described periphery.
14. implants according to claim 11, wherein, make the spaced described structure of described layer comprise at least circular knot and/or ball (116).
15. implants according to claim 11, wherein, make the spaced described structure (120) of described layer set up spiral in shape.
16. implants according to claim 11, wherein, comprise the spaced described structure (129) of described layer and define separately a plurality of hollow components that surround completely.
17. implants according to claim 11, wherein, make the spaced described structure (136) of described layer comprise a plurality of puffed rice elements.
18. implants according to claim 11, wherein, making the spaced described structure (144) of described layer is lobe shape, and comprises the stem of contiguous juxtaposed lobe each other and the end of the lobe that radially separates.
19. hernias are repaired implant, and it comprises:
The ground floor of being made by net (58), it to cover described defect, promotes that tissue grows into described ground floor from described body structure in the face of having the body structure of hernia defect simultaneously; And
The second layer relative with described ground floor and that made by anti-stick condensation material (60), to prevent that tissue from growing into the described second layer from the body structure contacting with the described second layer, wherein, described net defines hole dimension, and described ground floor is skeleton stratum reticulare, defines periphery and define at least one larger opening of hole dimension described in the ratio within described periphery.
20. implants according to claim 19, it comprises:
Be connected on described ground floor and in the first radial position place and be connected at least the first microscler band (34) that centers on described ground floor; And
Be connected on described ground floor and in the second radial position place and be connected at least the first microscler fixing band (40) on described ground floor, described the second radial position is more farther from the center of described ground floor than described the first radial position.
21. implants according to claim 19, wherein, the described second layer radially extends beyond described ground floor.
CN201380009251.XA 2012-02-13 2013-01-10 Implant for hernia repair Pending CN104203123A (en)

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