Source: https://patents.google.com/patent/CN104688280B/en
Timestamp: 2020-01-29 18:54:40
Document Index: 723413168

Matched Legal Cases: ['Application No. 201010145524', 'art 40', 'art 60', 'art 60', 'art 60', 'art 60', 'art 60', 'art 60', 'art 60', 'art 60', 'art 74', 'art 72', 'art 72', 'art 72', 'art 72', 'art 72', 'art.\n4']

CN104688280B - Organization bracket delivery system - Google Patents
Organization bracket delivery system Download PDF
CN104688280B
CN104688280B CN201510069563.0A CN201510069563A CN104688280B CN 104688280 B CN104688280 B CN 104688280B CN 201510069563 A CN201510069563 A CN 201510069563A CN 104688280 B CN104688280 B CN 104688280B
CN201510069563.0A
CN104688280A (en
M.Z.森根
2009-03-27 Priority to US12/412499 priority Critical
2009-03-27 Priority to US12/412,499 priority patent/US8241298B2/en
2010-03-29 Application filed by 德普伊米特克公司 filed Critical 德普伊米特克公司
2010-03-29 Priority to CN201010145524.1A priority patent/CN101953698B/en
2015-06-10 Publication of CN104688280A publication Critical patent/CN104688280A/en
2017-06-20 Publication of CN104688280B publication Critical patent/CN104688280B/en
The invention provides the method and apparatus for delivering and attaching tissue substituent.In one embodiment, organization bracket can be delivered to the cavity in patient's body by intubation, defect of the cavity in the tissue of such as cartilage is formed.The stent delivery can be passed through into the intubation with delivering axle, and can help be loaded into the support on the delivering axle with block is loaded.The support can be set and be temporarily fixed in the cavity by delivering guider.One or more surgical operating instruments can be imported the support by delivering guider, the support is attached in the cavity with using at least one fixed mechanism, for example, on the bone being attached to below the support.
Organization bracket delivery system
The application is that the Application No. 201010145524.1, applying date is the patent of invention of the same name on March 29 in 2010 The divisional application of application.
Method and apparatus the present invention relates to be used to deliver and attach organization bracket.
Soft tissue (such as cartilage, skin, muscle, bone, tendon and ligament) is frequently necessary to by surgical operation when injured Damaged to repair and promote to heal.Such surgical repair can include：Sutured by known medicine equipment or with other Mode repairs damaged tissues, by other tissue filling damaged tissues, uses any group of implant, graft or these technologies Close.
A kind of common tissue damage is related to cartilage damage, and cartilage is a kind of flexible connective group without blood vessel, with resilience Knit, cartilage plays the effect of " damper " generally at articulation, but the cartilage of some types also can be to tubular structure (example Such as larynx, tracheae and ear) supporting is provided.Cartilaginous tissue generally by the cartilage cell in extracellular matrix (commonly referred to Chondrocytes) constitute, extracellular matrix includes collagen, structure stand and a kind of aggrecan (egg of packing space White glycan).The cartilage of several types, including hyaline cartilage, fibrocartilage and elastic cartilage are can be found that in human body.Hyaline cartilage Obvious sheet is shown as in human body, or, it can be found that such cartilage fusion is in the joint end of bone.Generally It is present in the hyaline cartilage in human body for articular cartilage, costal cartilage and fetal cartilage (that is, are eventually converted by ossific process It is the cartilage of bone).Fibrocartilage be one kind be usually located at tendon and bone, bone and bone and/or hyaline cartilage with it is transparent Tissue of dividing a word with a hyphen at the end of a line between cartilage.Elastic cartilage includes the elastomer for spreading all over extracellular matrix, and it is typically found in epiglottis portion, ear Portion and nose.
The example of one common hyaline cartilage damage is the focal articular cartilage defect of knee.Intense impact joint can lead The cartilage piece of the mobile all size in part and shape is caused, or is enough to damage the extracellular matrix of cartilage, so as to cause cartilage degeneration. If do not treated, the articular cartilage of damage can be limited function of joint, and weak pain is made us in generation, and may be caused Long-term chronic disease, such as osteoarthritis, this disease are characterised by that unfavorable change occur in cartilage destruction and the sclerotin under it Change.Due to articular cartilage tissue damage typically will not self-healing, therefore generally have to repair symptomatic focus by surgical operation. Existing Therapeutic mode includes lavation, removes partially or even wholly disjunct tissue block.Additionally, surgeon will generally make With various methods that can cause cartilage defect bleeding and form clot, for example, strike off, drill or micro fractures.It is believed that coming from The cell of marrow can be formed and be essentially fibrocartilaginous scar shape tissue, and can only some symptoms be provided with temporary transient delaying Solution.Unfortunately, the tissue of reparation do not have with hyaline cartilage identical mechanical performance, therefore can because of abrasion with the time more Degenerate soon.Patient generally needs to carry out second operation to carry out relief of symptoms.
Recently, the experimental technique application for being related to Autologous Chondrocyte to transplant is more and more universal.Use biopsy Method removes a piece of cartilage from patient, and cell is then extracted from tissue samples, and is cultivated in the lab to suitable Quantity, so as to obtain cartilage cell.Then the cartilage cell that will be expanded is in the form of cell suspension or pre- mounted in synthesis or day Right can be supplied to surgeon in the biocompatible scaffold of biodeterioration, to be implanted into cartilage defect.Sometimes, by this A little living cells are placed in the natural or synthetic support of three-dimensional or matrix, and are maintained under tissue specificity condition of culture, with shape Into transplantable functional organization's substitute.If having suitable condition and signal, cell can breed, break up and secrete many Plant substrate molecule, to form actual living tissue, its replacement tissue that can be used as planting back patient's defect.
Other are used to repair the technology of damaged cartilage using the cell outside cartilage cell, to form required transparence group Knit.Stem cell or progenitor cells (such as the cell in adipose tissue, muscle or marrow) have regenerated in patient's body bone and/ Or the potential of cartilage.Stem cell can take from patient's (i.e. autologous), or take from another patient (i.e. allosome).Except other are thin Born of the same parents' (such as cell from synovial membrane) outward, when these progenitor cells are placed in be conducive to inducing in chondrogenetic environment when, according to recognizing For they are renewable into cartilaginous tissue.
Other include using surgery implant, support or matrix by the surgical technic of operative treatment injury tissue.It is existing Various surgical implants are applied to surgical operation, to help the regeneration of cartilage in the case where cell is not used.For example, implantation Thing can by it is porous, can biodeterioration, biocompatible polymer matrix matter formed.Other examples are included derived from biopolymerization The matrix of thing (such as hyaluronic acid, collagen and fibrin).These implants generally combine marrow stimulating technology (such as micro- bone Folding) use so that marrow can provide cell and contribute to other of regeneration of cartilage to irritate thing.
Before by implant implantation within a patient, it is necessary to which defect and implant are prepared, to ensure implant With the cartilage good combination around defect.The degeneration of the defect of patient or injury tissue must be removed during preparation.Especially Its in the limited arthroscopic surgery of passage for entering operative site, in order to farthest reduce to neighbouring health cartilage And/or any wound of subchondral bone bone (bone i.e. below defect), the space cleaning of defect can be difficult and time consuming.Separately Outward, it is necessary to which implant is prepared, the size that it is formed from laboratory is trimmed to and the defect cleared up in patient's body Position space matches.It is that cannot accurately define plant before space at defect in patient's body forms and can determine that size Enter the size of thing, it is therefore necessary to prepare implant for specific implantation during operation is carried out.In nervous operation Cheng Zhong, the size of implant determines that mistake may extend operating time, and can result in the need for the size weight of tissue substituent Newly adjust to acceptable size.In some cases, it is intended to which the size for adjusting implant can cause the plant without suitable dimension Enter thing, if being slit into the size that cannot be used for one or more.The implant that cannot be used is caused must be by another high The process that expensive, time-consuming and medical science is invaded forms another graft, and another transplanting is then attempted patient again.
Therefore, there is still a need for for by the method and apparatus of implant implantation within a patient.
Method and apparatus present invention relates generally to be used to deliver and attach organization bracket.In one embodiment, there is provided A kind of organization bracket Load System, the system includes the delivering axle with least one tip, and tip is stretched from delivering axle distal end Go out and be configured to through organization bracket.Organization bracket Load System also include load block, load block have be configured to group Mount surface thereon is knitted, the surface has at least one opening for being formed wherein, and is configured to receive delivering At least one tip on axle so that at least one tip can run through the organization bracket laid on said surface. Loading block also includes guiding elements, and guiding elements stretches out from the surface, and with least one groove formed therein, the groove Be configured at least one opening that at least one tip is imported on the surface.
Organization bracket Load System can have many modifications.For example, at least one tip can include two points Head, at least one opening can include two openings, and at least one groove can include two grooves.It is formed in loading block At least one opening in surface can be the form of elongated slot, and the elongated slot is configured to allow on slender axles At least one tip is slided wherein.And for example, at least one opening may be located at the terminal edge away from the surface At predetermined distance so that at least one tip will be through placement on said surface and with the adjoining terminal edge Periphery organization bracket on precalculated position.In certain embodiments, guiding elements can have be approximately perpendicular to the table Part I and be roughly parallel to the Part II that the surface extends that face extends, at least one groove is in the second portion Formed.Organization bracket Load System can include the organization bracket with multiple holes, and each hole is respectively provided with and described at least one The diameter that the diameter of tip is substantially identical.
In certain embodiments, organization bracket Load System can include the delivery cannula with inner chamber, and inner chamber is through slotting Manage and be configured to receive delivering axle wherein.Funnel removably can coordinate with the distal end of delivery cannula.Delivering axle can To be configured to insert the distal end of delivery cannula, and delivery cannula can include block, and block is configured to limitation delivering axle Moved proximally in delivery cannula, at least one tip is positioned at the pre-position in delivery cannula distal end. Organization bracket Load System can also include delivering guider, and delivering guider is slidably disposed on delivering axle, and is had It is configured to engage organization bracket (being arranged at least one tip on delivering axle distal end) and fix organization bracket Distal end in bone surface.
In another embodiment, there is provided a kind of organization bracket delivery system including delivering guider, delivering is oriented to Utensil has the inner chamber for passing through and at least one tooth stretched out from its distal circumference.At least one tooth is configured to be pierced into Organization bracket simultaneously engages bone, and organization bracket is maintained at into fixed position relative to bone.Delivering guider also includes neighbouring At least one window of distal end, the window is configured to observe and sets the part in distal end in the lumen.
Organization bracket delivery system can have various modifications.For example, at least one window can include it is many The individual opening being formed in delivering guider and/or the transparent part being formed in delivering guider.In certain embodiments, pass Sending guider can include registration mechanism, and its instrument for being configured to be inserted is positioned at pre- relative to delivering guider Determine radial position.Organization bracket delivery system can include perforating tool, its inner chamber for being configured to be pushed into delivering guider, And the bone for preparing for connecting organization bracket.Bone preparation tool can include the perforating tool with least one tip, The tip is configured to get at least one through hole on the organization bracket fixed by least one tip, and enters tissue Bone below support.And for example, organization bracket delivery system can include support instrument in place, and it is configured to be pushed into delivering The inner chamber of guider.Support instrument in place can include that fastener applies instrument, and it has the fastener holding member positioned at distal end, and And at least one fastener of holding is may be constructed such that, and the fastener is passed through by least one tissue of tooth fix in position Support, organization bracket is fixed on the bone below organization bracket.And for example, organization bracket delivery system can include delivering Axle, delivering axle has at least one tip stretched out from its distal end.At least one tip may be constructed such that through tissue Support, and deliver guider and can be arranged on delivering axle so that at least one tooth is configured to engagement and is arranged on pass Send the organization bracket at least one tip of axle.In certain embodiments, organization bracket delivery system can include passing Sending intubation, delivery cannula has the funnel for being connected to its distal end, and deliver axle can be slideably disposed to be inserted through delivering Pipe.
On the other hand, there is provided a kind of method for being loaded into organization bracket on delivering axle, the method includes：Will Organization bracket is arranged on loading block surface so that organization bracket is arranged on and is configured at least one of described surface opening On, and by least one tip stretched out from delivering axle distal end along at least formed in the guiding elements on block is loaded Individual groove propulsion.At least one groove guides at least one tip through organization bracket and is opened into described at least one Mouthful.
The method can have many modifications.For example, guiding elements can guide at least one tip relative to The pre-position on organization bracket periphery passes through organization bracket.And for example, at least one opening can include that at least one is thin Slit long, and the method can also include at least one tip slipping at least one slit, and will described in extremely A few tip is exited from least one slit, and still allows organization bracket to be connected on tip.In certain embodiments, By organization bracket be arranged on load block surface on step can include allow organization bracket peripheral adjacent guiding elements table Face and/or at least a portion of organization bracket is arranged under at least a portion of guiding elements.Work is provided with organization bracket Histiocytic surface can be configured so that contact loads the surface of block.
On the other hand, there is provided a kind of method for delivering organization bracket, the near-end push-in that it includes delivering axle The distal end of delivery cannula, the organization bracket that will be arranged on delivering axle distal end is arranged in the distal end of delivery cannula.Work as tissue When support is pushed into the distal end of delivery cannula, delivery cannula makes organization bracket around at least one tip on delivering axle distal end Fold.
The method can have many modifications.For example, organization bracket can include living group be arranged on its first surface Knit cell.Can prevent the first surface when organization bracket is folded from contacting the inner surface of delivery cannula, so as to protect living tissue Cell.And for example, delivery cannula can include the funnel positioned at its distal end folded tissue support.And for example, the method can include inciting somebody to action In intubation push-in patient's body with the organization bracket and delivering axle that are disposed therein, and will deliver at least one described on axle Individual tip is positioned on bone, with position tissue support.In certain embodiments, the method can also include removing intubation, and Delivering axle and the organization bracket stretched into patient's body are left, and delivering guider is advanced on delivering axle, to cause delivering The distal engagement organization bracket of guider simultaneously engages bone, so as to organization bracket is maintained at into fixed position in bone surface. The method can also include removing delivering axle, and leave the delivering guider stretched into patient's body and organization bracket is fixed on into bone On bone surface, and by perforating tool through delivering guider, through organization bracket and enter bone, with formed in bone to A few hole.Perforating tool can optionally through the formation in delivering guider and adjacent at least the one of delivering guider distal end Individual window is observed.Delivering guider can have registration mechanism, for by perforating tool with predetermined radial oriented relative In delivering guider alignment.The method can also include removing perforating tool from delivering guider, and fastener is applied into instrument Insertion delivering guider, so as at least one fastener passes through organization bracket and enters through perforating tool be formed extremely in bone A few hole.Delivering guider can have registration mechanism, for by fastener apply instrument with it is predetermined it is radial oriented relative to Delivering guider alignment.
In another embodiment, there is provided a kind of method for delivering organization bracket, it includes that guider will be delivered Distal end be arranged on organization bracket and be close to bone surface, organization bracket is maintained at fixed bit relative to bone surface Put, and fastener is applied into instrument push-in delivering guider, fastener is inserted into organization bracket and enters bone, so that will tissue Support is fixed at position fixed on bone.
The method can have various variation patterns.For example, the distal end of positioning delivery guider can include being oriented to delivering At least one tooth on device is pierced into organization bracket and enters bone.And for example, the method can be included in and push away fastener applying instrument Enter before delivering guider, by perforating tool push-in delivering guider, to be formed through organization bracket and enter bone at least One hole, to receive at least one fastener.In certain embodiments, the alignment feature on delivering guider can apply fastener Instrument radial oriented is alignd with predetermined relative to delivering guider.And for example, the method can be included in positioning delivery guider Distal end before, organization bracket is positioned in bone surface using axle is delivered.Delivering guider can be advanced on delivering axle, with The remotely located of guider will be delivered and on organization bracket and be close to bone surface.
By " specific embodiment " hereafter and with reference to accompanying drawing, the present invention can be more fully understood from.Now by each brief description of the drawings It is as follows：
Fig. 1 is the fragmentary, perspective view of one embodiment of delivery system, and the delivery system includes being connected with organization bracket Delivering axle, delivering axial proximal direction is pushed into the intubation for having funnel in distal end；
Fig. 2A is the decomposition diagram of the delivering axle of Fig. 1；
Fig. 2 B are the sectional view of the one embodiment for the locking device formed in the delivering axle of Fig. 2A；
Fig. 3 is the perspective view of the one embodiment for loading block；
Fig. 4 is the side view of the loading block of Fig. 3；
Fig. 5 is the top view of the loading block of Fig. 3；
Fig. 6 is the top view of the cross section of the main body of the loading block of Fig. 4；
Fig. 7 is the amplification vertical view of the loading block of Fig. 5；
Fig. 8 is the fragmentary, perspective view of the delivering axle of the organization bracket and Fig. 2A of Fig. 1, and the organization bracket is located at the dress of Fig. 3 Carry on the surface of block, the tip of its distal end is pushed organization bracket by the delivering axle using block is loaded；
Fig. 9 is the partial side view of the organization bracket of Fig. 8, and the organization bracket is connected on the tip of delivering axle；
Figure 10 is the side view of the intubation of Fig. 1；
Figure 11 is the decomposition diagram of the intubation of Figure 10；
Figure 12 is the cross-sectional side view of the funnel of the intubation of Fig. 1；
Figure 13 is the distal end view of the funnel of Figure 12；
Figure 14 is the perspective view of the local transparent of the support of Fig. 1, and the support is connected on the tip of delivering axle, and to fold Configuration is arranged in intubation；
Figure 15 is the partial cross-section perspective view of the intubation of Fig. 1, and the intubation just lacks through tissue in patient's in-vivo tissue Damage the cavity propulsion that position is formed；
Figure 16 is the partial cross-section perspective view of the delivering axle of Fig. 1, and the delivering axial distal end direction is pushed into inserting for Figure 15 Pipe, organization bracket is just from the distal advancement of intubation；
Figure 17 is the partial cross-section perspective view of the intubation of Figure 16, and the intubation is moved from around delivering axle and in patient's body Remove；
Figure 18 is the side view of the one embodiment for delivering guider；
Figure 19 is the enlarged side view of the distal end of the delivering guider of Figure 18；
Figure 20 is the sectional view of the distal end of the delivering guider of Figure 18；
Figure 21 is the sectional view of the distal end of the delivering guider of Figure 18；
Figure 22 is another side view of the delivering guider of Figure 18；
Figure 23 is the enlarged side view of the distal end of the delivering guider of Figure 22；
Figure 24 is the perspective view of the distal end of another embodiment for delivering guider, and the delivering guider has transparent remote End part, and with removable distal loop, the annulus has at least one bone engagement element for stretching out from it；
Figure 25 is the perspective view of the near-end of another embodiment of the delivering guider with registration mechanism；
Figure 26 is the partial cross-section perspective view of the delivering guider of Figure 18, and the delivering guider is on the delivering axle of Figure 17 Propulsion, and push the organization bracket being connected on delivering axle to；
Figure 27 is the partial cross-section perspective view of the delivering guider of Figure 26, and the delivering guider is advanced on delivering axle, And organization bracket is maintained at position fixed in the cavity of tissue defect site；
Figure 28 is the side view of one embodiment of perforating tool；
Figure 29 is the partial cross-section perspective view of the perforating tool of the Figure 28 being arranged in the delivering guider of Figure 27, wherein Delivering axle is removed from delivering guider, and with the near-end of hammer perforating tool, with the organization bracket in cavity With one or more holes are got in the bone below organization bracket；
Figure 30 is the partial cross-section perspective view that the fastener being arranged in the delivering guider of Figure 29 applies instrument, wherein wearing Hole instrument is removed from delivering guider, and by one or more fasteners through the hole with perforating tool formation；And
Figure 31 is the perspective view of the organization bracket that the Figure 30 with patient is connected to fastener.
Some exemplary embodiments will now be described to provide structure, function, the system to device disclosed herein and method Make the comprehensive understanding with use principle.One or more examples in these embodiments are shown in the drawings.People in the art Member will be understood that the apparatus and method for specifically describing herein and being shown in the drawings are non-restrictive illustrative embodiment and this hair Bright scope is limited only by the appended claims.The feature for showing or describing with reference to an exemplary embodiment can be with other implementations The combinations of features of example.This modification and variations are intended to be included in the scope of the present invention.
Present invention relates generally to be used to deliver the methods and apparatus with Attaching implants.Generally, the present invention is disclosed The multiple types of tools and technology of the cavity formed for the defect being delivered to organization bracket in tissue (such as cartilage). In one embodiment, there is provided delivering axle, it is used to engage support and under arthroscope by the defect in stent delivery to tissue Position.There is provided can be used for the convenient loading block being loaded into support on delivering axle, and there is provided for holding in delivery process The intubation received with protective cradle.After by stent delivery to defect, support can be attached to various attachment devices and lacked Damage in the cavity formed in the tissue at position.For example, in one embodiment, there is provided delivering guider, it is used in (example Held the stent in cavity during during such as) removing delivering axle and organization bracket is connected on bone.In addition Additionally provide for forming one or more in bone through the perforating tool in the holes of support, and there is provided for by fastener It is delivered to support and applies instrument to connect the holder to the fastener on bone.Perforating tool and fastener apply instrument can be constructed It is through delivering guider.Present invention therefore provides multiple types of tools, these instruments can be used in combination with various combinations, with Assisted delivery organization bracket is simultaneously attached it in the cavity of tissue defect site formation.
It should be known to those skilled in the art that " tissue " is intended to multiple material as the term is employed herein, for example Any other material that cartilage, organ and available organization bracket are repaired, and term used herein " cartilage " can refer to it is any The cartilage of type, such as hyaline cartilage, fibrocartilage and elastic cartilage.Those skilled in the art will also recognize, such as this paper institutes Term " defect " be intended to the existing or former damage that preparation implant is repaired in tissue, it is unhealthy or because The bad position of other aspects.Those skilled in the art it is to be understood that as the term is employed herein " tissue substituent ", " implant ", " support " or " matrix " is intended to any being configured in implantable patient's body to realize tissue repair and regeneration Operation on safety implant.
Those skilled in the art will also recognize, although herein in conjunction with minimally invasive arthroscopy (in this kind of operation, outward The small opening that section's operation device passes through to be formed on a patient body percutaneously introduces body cavity) method and apparatus are described, but herein Disclosed method and apparatus can also be used for including the various other surgical operations including small otch and open surgery, and Can be used together with various surgical operating instruments.Although those skilled in the art herein in conjunction with cartilage it is to be understood that repair Method and apparatus are described again, but methods described and device can also be used for other tissue repairs related to knee, such as knee Cartilage at bone, or the tissue repair related to other articular surfaces, such as shoulder, ankle, stern and elbow, and be implanted into using tissue substitute Other any kind of tissue repairs of thing.
In one exemplary embodiment, can to the patient with cartilage damage the articular surface of Bones and joints defect It is prepared, to carry out tissue repair operation.The otch formed by arthrotomy, can open knee joint, and exposure is fallen vacant Damage position.The size and shape of damage can be with difference, but the damage of femur condyle is for about 3cm generally with surface area2(300mm2) Elliptical shape.Bad cartilaginous tissue (can include that fibrosed tissue and cracking are organized) can be removed, so that in the tissue Form cavity.During damaged portion is removed, it is also possible to remove some healthy cartilages adjacent to damage location.Articular surface is clear Wound should be deep enough, to expose the calcified layer and/or subchondral bone surface of cartilage, such as about 2 to the 3mm under cartilage top surface Scope, to receive tissue repair implant.Bone surface can provide substantially smooth surface for placing implant and Can be with the rock-steady structure of Attaching implants.After articular surface is ready, tissue repair implant can be implanted in shape in cartilage Into cavity, be placed on articular surface.In certain embodiments, a part for bone can be removed, and implant is implanted in In the cavity formed in cartilage and bone.
Before implant is put into patient's body, implant can be formed with living tissue, such as in the first surgical operation In from patient's collection, living, unspoiled histocyte, the first surgical operation and the surgery being put into implant in patient's body Operation is separately carried out, and the example of the latter is Autologous Chondrocyte transplanting (ACI) operation, is such as usedImplant (is derived from Genzyme Corporation, Cambridge, MA) operation.However, it will be appreciated by those skilled in the art that living tissue Can or instead in the same surgical procedure being transplanted to implant in patient's body gather.
It will be appreciated by those skilled in the art that living tissue can be gathered from patient by any mode.For being adopted from patient The multiple non-limiting examples (such as biopsy procedure) for collecting the method and apparatus of tissue are found in the announcement of on October 3rd, 2006 , the United States Patent (USP) of entitled " Tissue Biopsy And Processing Device " (tissue biopsy and processing unit) No.7,115,100；On March 27th, 2008 submits to, entitled " Tissue Extraction and Collection The U.S. Patent Publication No.2008/0234715 of Device " (tissue extraction and harvester)；And September in 2003 is carried on the 11st U.S. hand over, entitled " Tissue Extraction and Maceration Device " (tissue extraction and immersion system) State patent disclosure No.2005/0059905, the full text of the patent is hereby incorporated by reference.
With difference, and can organize and with variform, but in the exemplary embodiment, can obtain in living tissue source Tissue include cartilage cell.In one exemplary embodiment, after obtaining living tissue sample, this can aseptically be processed Tissue samples, form the suspension with tissue particles at least one in small, broken bits or subdivision.Also the group of form in small, broken bits can be obtained Knit, so as to without further processing.It will be appreciated by those skilled in the art that living tissue block in small, broken bits is living, unspoiled The sub-fraction of tissue, tissue block in small, broken bits can strengthen the effect of regeneration and healing reaction.The granular size of each tissue block Can be with difference.Used as non-limiting examples, the size of tissue particles can be in about 0.001 to 3mm3In the range of, but tissue Particle is preferably less than about 1mm3.In another embodiment, living tissue can be the histotomy obtained from health tissues Or the form of strip of tissue, comprising that can make regeneration and/or the living cells reinvented, such as on December 5th, 2003 carries health tissues Handing over, entitled " Viable Tissue Repair Implants and Methods of Use " (living tissue reparation is implanted into Thing and application method) U.S. Patent Publication No.2005/0125077 described in, it is hereby incorporated by reference in full. The histotomy with the geometry for being adapted to be implanted into damage or defect, the size of the histotomy of acquisition can be obtained Should allow the living cells included in histotomy can move out, breed and with repair position around organizational integration.Art technology Personnel should be known that can be from patient and/or the donor for matching collection tissue, and tissue can be artificial organization material, with And any combinations of the tissue and artificial organization material for obtaining can be used.
From patient obtain living tissue can optionally with various other combinations of materials, including carrier, such as gel phase carriers Or binding agent.Living tissue contacting substrate digestive ferment can be made, so as to be conducive to tissue from the extracellular matrix around living tissue Move out.Enzyme can be used to improve cell and move out and extracellular matrix and enters the speed of implant.Gel phase carriers, adhesive and enzyme Multiple non-limiting examples are found on 2 9th, 2004 submit to, entitled " Scaffolds With Viable The U.S. Patent Publication No.2005/0177249 of Tissue " (have living tissue support), it is in full accordingly by reference simultaneously Enter herein.Submitted on November 26th, 2003 on living tissue source and other non-limiting examples for preparing living tissue method , entitled " Conformable Tissue Repair Implant Capable Of Injection Delivery " (energy Enough inject the conformal tissue repair implant for giving) U.S. Patent Publication No.2005/0113937 in have disclosed, it is in full It is hereby incorporated by reference.
Any material that can be combined by living tissue and with living tissue is loaded on organization bracket.Those skilled in the art It should be known that support can have various configurations.In general, support can with the substantially any material having the following properties that or Delivery vector is formed, they for bio-compatible, bioimplantable, be easy to sterilization and with enough structural integrities Property and/or physical and mechanical property, to be effectively provided in the convenience processed under operating room environment, and allow it to receive and keep One or more fixed mechanisms (such as suture, staple, binding agent) and will not substantially tear.As non-limiting examples, branch Frame can be by including can be including resorbable material, non-biological material and/or synthetic material any one or more of material shape Into matrix form.Support can be flexible, to allow support to conform to the shape and size of implantation target spot.Support is also Bioabsorbable and/or bioresorbable component can be included, as temporary carrier, so as to improve transport process The treatment of middle implant.Multiple non-limiting examples of organization bracket are found in above-mentioned, submission on 2 9th, 2004 , the U.S. Patent Publication of entitled " Scaffolds With Viable Tissue " (have living tissue support) No.2005/0177249；And on 2 25th, 2003 submit to, entitled " Biocompatible Scaffolds With The U.S. Patent Publication No.2004/0078090 of Tissue Fragments " (there is the biocompatible scaffold of tissue block), Submit to, entitled " the Method And Apparatus For Resurfacing An Articular on the 11st of August in 2003 The U.S. Patent Publication No.2005/0038520 of Surface " (method and apparatus of rebuilding articular surface), and on April 26th, 2005 Submit to, entitled " Use of Reinforced Foam Implants with Enhanced Integrity For Soft Tissue Repair And Regeneration " are (for soft tissue repair and the adding with enhancing integrality of regeneration The use of strong type foam implant) United States Patent (USP) No.6,884,428, the patent is incorporated by reference in its entirety accordingly Herein.
It will be appreciated by those skilled in the art that tissue that can be in any way to being obtained from patient be prepared and by its It is loaded on support.Can be during or after support be prepared, or before or after implant is placed in patient's body The part of tissue is added on support.It is optionally possible to bioactivator to be compounded in organization bracket and/or be coated to On organization bracket, and/or can apply it in living tissue.Preferably, it is before living tissue is added on support, biology is living Property agent be compounded in support or be coated on support.Bioactivator can be selected from various effectors and cell, when being present in damage During the position of traumatic part, they can promote the healing and/or regeneration of affected tissue.The multiple non-limiting implementation of effector and cell Example is found in above-mentioned, on 2 9th, 2004 submit to, entitled " Scaffolds With Viable Tissue " (tools Have living tissue support) U.S. Patent Publication No.2005/0177249.Tissue (living tissue such as in small, broken bits) is applied to support On multiple non-limiting examples be found in (such as) on March 28th, 2003 submission, entitled " Tissue The U.S. Patent Publication No.2004/ of Collection Devices And Methods " (tissue collecting device and method) 0193071, it is hereby incorporated by reference in full.
As described above, after organization bracket can be used for implantation within a patient, the standard before structural transplantation can be carried out to patient Standby, method is to remove defect cartilage, is formed in cartilage from cartilage surface and extends to following femur condyle or other positions Hole or cavity, as described above.The preparation before structural transplantation can be carried out to defect in many ways.In an exemplary implementation In example, can be under arthroscope with being configured to cut in the tissue the surgical operation cutting element of the predetermined shape shape in cartilage Into the otch with predetermined shape so that the shape of otch is around damage location.Cartilage can be removed from the shape of otch, made Obtaining the shape of otch can limit the periphery of Tissue cavities of implantable stent.In certain embodiments, cutting element can be used Multiple shapes are cut in cartilage, each shape is Chong Die with least a portion of damage location, and optionally with least one Other cutting profiles are overlapped.Can also change and/or connect these shapes using identical and/or other cutting element.Can With the cartilage in the cutting profile for removing combination, to limit the shape of the cavity for receiving support.Prepare tissue (to be included in tissue Formed receive support cavity) multiple non-limiting examples be found in it is being submitted on the same day with present patent application, entitled " Methods And Devices For Preparing And Implanting Tissue Scaffolds " is (for preparing With the method and apparatus of implanting tissue scaffolds) U.S. Patent application No. [] [attorney 22956-869 (MIT5113USNP)], it is incorporated by reference accordingly in full.Those skilled in the art will be appreciated that, it is also possible to use it His cutting element or manual techniques are prepared to defect.
As needed remove defective tissue to form cavity after, implant can be prepared be delivered into cavity and Optionally it is fixed in cavity.Generally, the implantation of the desired size (for example, more than size of defect) more than cavity is formed Thing, and the size and dimension substantially matched with cavity is cut into surgical procedures.So, can be from the group for preparing Knit and cut a part and obtain implant on replacement implant, deposition living tissue of this part comprising high concentration, because tissue is usual Can be adhered on whole tissue substitute implant with different concentration.Additionally, (such as) is if defect than determining before It is big, if the health tissues to be removed are more etc. than initially expected, then the cavity size of formation can be with surgical procedure More than or less than desired size.Therefore, implant is cut into the suitably sized chi for helping to make implant in surgical procedure The very little actual size with cavity matches.
Tissue substitute implant can be trimmed to required size and dimension with various methods.In an exemplary implementation In example, (can be configured to that the predetermined shape that is cut into the cleavable tissue with defect is corresponding to be made a reservation for cutting element Shape) substitute implant from Cut tissue on the larger implant for preparing.In another exemplary embodiment, Ke Yiyong Template tool determines the size of defect and helps cut the tissue substitute implant of required size.Template tool can have There are various configurations, such as adjustable formwork instrument or flexible membrane with least one adjustable opening, it is possible to which various ways are used To set the size of implant.For organization bracket is trimmed to required size and dimension method and apparatus it is multiple unrestricted Property embodiment be found in above-mentioned submitting on the same day with present patent application, entitled " Methods And Devices For Preparing And Implanting Tissue Scaffolds " are (for preparation method and dress with implanting tissue scaffolds Put) U.S. Patent application No. [] [attorney 22956-869 (MIT5113USNP)].
Cavity is howsoever formed in tissue, regardless of how forming tissue substitute implant and be cut to and chamber Show consideration for close required size, can any mode implant is delivered in cavity and bone is attached to and/or calcified cartilage On.In the exemplary embodiment shown in Fig. 1, it is configured to that the instrument that organization bracket 10 is delivered to connecting portion can be included Delivering axle 12, delivering axle 12 be configured to be slidably received in delivery cannula 14, delivery cannula 14 have removably connect It is connected to the funnel 16 of its distal end 14a.Will be further discussed as follows, funnel 16 may be constructed such that the distal end that will be connected to axle 12 Plane configuration of the support 10 of 12a from outside intubation 14 moves to the U-shaped folding configuration in intubation 14.When with being connected thereto At least a portion of the axle 12 of support 10 is arranged on when in intubation 14, can be inserted into the patient by intubation 14.Can pass through and insert Pipe 14 distally advances axle 12, so as to support 10 distad to be released the distal end 14a of intubation 14, and enters in patient's body.Will branch Frame 10 is released from intubation 14 and support 10 can also be moved into plane configuration from folding configuration, can be by support under plane configuration 10 are connected to tissue defect site.
Although shown organization bracket 10 has elliptical shape, and to be provided with living tissue on one side thereof and with multiple The periplast of the hole 10a for passing therethrough, but support 10 can have various shapes, size and configuration.In some embodiments In, support 10 can have the thickness and about 10cm less than about 3mm2(1000mm2) surface area, to conform to stock size Tissue defect site.
Delivering axle 12 can also have sizes, shape and configuration.In this embodiment, as shown in Figure 2 A and 2B, pass Axle 12 is sent to may be constructed such that similar to forked, and it can be included in the distal end 12a of axle 12 and have at least one tip 20 Elongate body 18.Axle 12 can have any longitudinal length, but in the exemplary embodiment, axle 12 can be more long than intubation 14, To allow to be arranged on axle 12 in the inner chamber of intubation 14 or passage 22, while outside the distal end 14a that intubation is stretched out in distally, and The near-end 14b for stretching out intubation 14 in nearside is outer (referring to Figure 10 and Figure 11).The near-end 12b of elongate body 18 can have tapered Cone shape, for example proximally direction is tapered as shown in the figure, to help that the near-end 12b of axle 12 is inserted into intubation 12 first Funnel 16 in the 12a of distal end, this will be discussed further below.One or more parts of axle 12 can optionally include one Individual or multiple grasping mechanism (finger for such as moulding depression, decorative patterns, to be conducive to treatment and control lever shaft 12.
One or more tips 20 of axle distal end 12a can be generally configured to be pierced into and through organization bracket (such as support 10), support 10 is connected on axle 12, so as to be delivered into patient's body.One or more of tips 20 can have appoints What size, shape and configuration, and it is constructed with enough intensity so that axle 12 can serve as bone beam worker Tool.In the exemplary embodiment, each tip 20 has thick more than organization bracket (tip 20 is configured to connect to thereon) The longitudinal length 20l of degree, and the length 20l of more preferably each tip 20 is sufficiently large, to allow support-folding in point Around first 20, without allowing support to come off, this will be discussed further below.In the exemplary embodiment, each tip 20 Length 20l is in the range of about 15 to 35mm.In the exemplary embodiment, each tip 20 also has diameter D3, and the diameter is equal to Or less than the diameter of organization bracket (tip 20 is configured to connect to thereon), to help to prevent tip 20 from damaging support. In exemplary embodiment, the diameter D3 of tip 20 in the range of about 0.1 to 2mm, e.g., from about 0.5 to 1mm.Although being shown in figure Two tips 20, but delivering axle 12 can include any amount of tip 20.Additionally, in tip 20 each can with it is any Other tips 20 are identical or different.Tip 20 may be constructed such that the spike on the tapered remote top of with or without as depicted Or pin, the remote top is configured to contribute to tip 20 to be pierced into organization bracket.Tip 20 can be arranged in the remote of axle with any configuration End 12a, for example, be radially equally spacedly arranged in around the central longitudinal axis A of axle 12 as shown in the figure.There is single point in axle 12 In the embodiment of head, the single tip can be substantially aligned in the axial direction with central longitudinal axis A, or in other embodiment In, it is also possible to stagger with axis A.
Although the tip 20 for showing and elongate body 18 be integrally formed (in the exploded view shown in Fig. 2A, tip with it is thin Main body long is separated), but any one or more in tip 20 can be removably couplable in elongate body 18.At some In embodiment, tip 20 can be telescopic so that in extended position, tip 20 can distad stretch out elongate body Distal end, in advanced position, it can be contained in elongate body 18.Those skilled in the art will be appreciated that, can be with any Mode controls retraction and the elongation of movable tip, such as by starting the controlling organization of the near-end 12b of axle 12, such as knob, button, Control-rod, electronic signal communication device etc..Alternatively or in addition to scalable, one or more tips 20 Can be modular component, it is configured to be detachably connected to by any mode known to those of skill in the art In elongate body 18, such as threaded connection, snap-fitted etc..Therefore, it can will be with different size (such as with different straight Footpath) tip be connected in elongate body 18, to allow more effectively to connect axle 12 in identical or different surgical procedures It is connected on various organization brackets.Modularization tip can be optionally provided with the delivering axle as an external member part, and external member can be with Including delivery cannula and funnel.
Although axle 12 can be solid component as depicted, axle 12 can also wherein be formed including one or more Passage.For non-limiting examples, axle 12 can include the passage through its distal end 12a and near-end 12b, and passage is by structure Make to receive at least one surgical operating instrument for passing therethrough setting, being such as constructed can be by body fluid, tissue from Surgery The vacuum plant that position suctions out.
Axle 12 can also optionally include lock feature 24, and lock feature 24 is located between distal end 12a and near-end 12b, and And be configured to engage (hereafter will now be discussed) to the corresponding locking device in intubation 14, axle 12 is maintained at intubation 14 and is led to Pre-position in road 22.Lock feature 24 may be located at any position along the longitudinal length of axle 12.In order to contribute to At least one tip 20 is arranged in intubation 14, the longitudinal length L1 between the distalmost end of axle 12 and lock feature 24 can be less than Longitudinal length between the distalmost end of intubation 14 and intubation locking device.
Lock feature 24 can have various shapes, size and configuration.In the embodiment shown, lock feature 24 is thin Annular recess form formed in the surface of main body long 18, around the circumference of main body 18.The groove can be taper, with when locking When feature 24 is engaged with the corresponding locking device in intubation, can prevent axle 12 from being moved in intubation 14.Due in illustrated embodiment Axis 12 is configured to first push near-end 12b the distal end 14a of intubation 14, and is proximally advanced with by axle 12 through passage 22 Load wherein, therefore groove is outwardly tapered on the direction from distal end to near-end, to form vertical stop surface 23, in lock When tight feature 24 is engaged with the corresponding locking device in intubation, prevent axle 12 from being moved to nearside.Proximal taper can also allow for axle 12 are distally advanced in the pressure by applying towards distal end, and this will be discussed further below.Those skilled in the art Member will be appreciated that, although lock feature 24 can be the radial groove for being formed around the circumference of elongate body 18 as shown in the figure, but Various other locking technologies can be used, and can be formed in any part of axle 12 and/or intubation 14.
Lock feature 24 may be constructed such that：When axle 12 is pushed into intubation 14, its be formed in intubation 14 or with it His mode is connected to the corresponding locking device engagement in intubation 14, and this will be discussed further below.Therefore, locking device Axle 12 releaseably can be locked at the pre-position in passage 22 relative to intubation 14 with lock feature 24.This Sample, at least one tip 20 for being configured to connect to organization bracket can effectively be contained in passage 22 in desired manner It is interior, so that safe delivery is entered in patient's body.
Those skilled in the art be will be appreciated that, organization bracket 10 can be connected to the distal end of axle 12 in several ways 12a.In one embodiment, when the tip 20 of axle 12 passes through support 10, grasper can be with fixed support 10.The skill of this area Art personnel will be appreciated that, " grasper " is intended to any be configured to capture and/or fixed branch as the term is employed herein The surgical operating instrument of frame 10, such as tweezers, retractor, adjustable clamp, magnet, adhesive etc..In another embodiment, can be with Help predictably determine position of the tip 20 relative to support 10 using block is loaded.Fig. 3-7 shows of loading block 26 Exemplary embodiment, it is configured to help be connected to organization bracket 10 on delivering axle 12.
Generally, loading block 26 can include that main body 26a and guiding elements 26b, guiding elements 26b are at least partially disposed on Main body 26a tops.Main body 26a can include being configured to receiving top thereon to organize receiving surface 28 organization bracket. Top surface 28 can have the opening 30 that one or more are formed wherein, and these openings are at least partially through main body 26a Thickness, and be each configured to by deliver axle tip be received in wherein.When tissue substitute implant is placed in into top When on portion surface 28, tip can be imported formed in a part (being arranged on main body 26a tops) of guiding elements 26b In individual or multiple grooves 32, so as to support can be conducted into and imported in opening 30 at least in part.Then, can be from loading block 26 It is upper to remove the standoff delivering axle of connection, and introduced in patient's body support using axle is delivered, this hereinafter will further be begged for By.
Although loading block 26 can be made up of any combination of rigid material and/or flexible material, in exemplary implementation Block 26 is loaded in example Ya Fuli big Su Wei high-performance polymers companies in Georgia (are such as derived from by one or more rigid material (Solvay Advanced's Polymers, L.L.C (Alpharetta, Georgia))PPSU) structure Into so loading block 26 would not deform in use, and this can increase using loading block 26 stabilization, fill in desired manner Carry the possibility of support.Load block 26 can have it is suitably sized, with the tissue substitute implant with any size and with fill The delivering guider for carrying any size that be connected thereto for tissue substitute implant by block 26 is used cooperatively.Showing as depicted In example property embodiment, loading block 26 has the longitudinal length l of about 1.4 inches (35.6mm)1, about 0.8 inch (20.3mm) width W and about 0.85 inch of height h of (21.6mm) of degree.The main body 26a and guiding elements 26b of loading block 26 can have various Size, shape and configuration.In the illustrated embodiment, loading block 26 has rectangular box type main body 26a and organizes receiving from top The L-shaped guiding elements 26b that surface 28 is stretched out.
The top tissue receiving surface 28 of main body 26a can have sizes, shape and configuration.Top surface 28 can be with With any shape and the surface area being generally large enough, organization bracket is received into thereon.Top surface 28 can be constructed For sufficiently large so that the edge of support placed on it will not stretch out any edge of top surface 28, to contribute to support More stably it is arranged on loading block 26.In certain embodiments, top surface 28 can have greater than about 3cm2(300mm2) Surface area.In the illustrated embodiment, top surface 28 has about 0.94 square inch of (606mm2) surface area.Top surface 28 Can be rectangle as depicted, or can also have any other shape, such as oval, square.Top surface 28 Can be with generally planar, to allow substantially flat to lay organization bracket thereon.Those skilled in the art will know Road, top surface 28 can in single plane Longitudinal extending so that main body 26a has constant thickness t as depicted, or Top surface 28 can also at a certain angle extend on any one or more directions so that main body 26a has variable thickness t.In the illustrated embodiment, thickness t is for about 0.42 inch (10.7mm).If top surface 28 has inclination angle, can be towards drawing Lead component 26b inclinations so that the thickness t of main body 26a reduces towards guiding elements 26b directions, and this can help to top surface 28 On the edge of organization bracket be set to be close to the exterior surface 34 (towards top surface 28) of guiding elements 26b, this will be under It is discussed further in text.
Opening 30 in top surface 28 can also have any size, shape and configuration.Opening 30 may be constructed such that The tip 20 of axle 12 is received, and therefore there can be sufficiently large size, initially entered out with the arrival end for allowing pointed distal Mouth 30.Can be with standoff distance w2 between opening 30, it is for about 0.157 inch (4.0mm) in the diagram embodiment, and is corresponded to The distance between tip 20 on delivering axle 12.However, can be changed according to the delivering axle being used therewith apart from w2.Such as Shown in figure, opening 30 is each configured to elongated oval slit, and it is along the Longitudinal extending of top surface 28 and with about 0.4 The width w3 of longitudinal length 30l and about 0.065 inch (1.7mm) of inch (10.2mm), but opening 30 can have any taking To, size and dimension, such as circle, square, rectangle etc..Opening 30 can also have at least partially through main body 26a's Any depth of thickness t, and generally may be constructed such that deep enough so that it is unrestricted that tip 20 is pierced into support 10.Though So present embodiment illustrates two openings 30, but loading block 26 can include any amount of opening 30.Additionally, each is opened Mouth 30 can be identical or different with any other opening 30.Loading block 26 can also be included than through the tissue on top surface 28 Substitute the more opening 30 of multiple tips of implant.
Top surface 28 can optionally include being configured to provide the label 36 of the information about loading block 26.Although institute Indicating label 36 be printed on top surface 28, impressing or otherwise visible letter, but those skilled in the art will Will appreciate that, label 36 can have any size, shape and configuration, such as color or letter, any combinations of numbers and symbols. Those skilled in the art will also be appreciated that loading block 26 can include any amount of label, and every in addition to top surface 28 Individual label can also be configured in any part for loading block 26 by printing, impressing or other visual ways.Implement in diagram In example, the written explanation of label 36 marks the suggestion positioning that will be received into organization bracket thereon, by the group of organization bracket Knit side to be placed in down on top surface 28, this can help to the protection during implanting tissue scaffolds and is usually deposited at tissue branch Living tissue on frame side, this will be discussed further below.Another non-limiting examples of label 36 include loading block The size of 26 each part (such as top surface 28, opening 30 and groove 32).
As described above, the guiding elements 26b stretched out from the main body 26a for loading block 26 is L-shaped, but it is also possible to various chis Very little, shape and configuration.As shown in this embodiment, guiding elements 26b includes the first arm 38 and the second arm 40, and the first arm is substantially vertical Ground stretches out main body 26a, and the second arm generally perpendicularly stretches out the first arm 38, and extends above main body 26a so that the second arm 40 It is roughly parallel to the top surface 28 of main body 26a.Position of first arm 38 on top surface 28 can change, but real in diagram Apply in example, the first arm 38 stretches out from the end 28a of top surface 28.Any one in first arm 38 and the second arm 40 can With the longitudinal length longer than other side, or the longitudinal length of the two can be with equal, but in the illustrated embodiment, the first arm 38 With the longitudinal length l than the second arm4(about 0.177 inch (4.5mm)) longer longitudinal length l3(about 0.43 inch (10.9mm)).The longitudinal length l of the second arm4Can limit since the periphery of the support 10 being arranged on top surface 28 Preset distance, the distance can push the distance of support 10 for the tip 20 of delivering axle 12.Therefore, it can the longitudinal direction of the second arm Length l4It is configured to allow for support 10 to be folded around tip 20 when intubation 14 is pushed into, this hereinafter will further be begged for By.Longitudinal length l can be selected according to the length of the tip 20 of axle 123, to cause the support being arranged on loading block 26 upward Send at the required position of tip 20, for example, in the embodiment shown at about half length.
As it was previously stated, guiding elements 26 is additionally may included in one or more grooves 32 for wherein being formed, for by tip 20 Import opening 30.The groove 32 formed in guiding elements 26b can also have sizes, shape and configuration.Generally, groove 32 can To be configured to each be received in wherein the tip for delivering axle, and tip imported into pre-determined bit in a predetermined direction Put, such as towards the one of opening 30 in top surface 28.So, tip can be pushed in foreseeable required position Support on top surface 28.
Groove 32 can correspondingly be axially aligned with opening 30, i.e., each groove 32 corresponds to an opening 30.Although this Being shown in embodiment corresponding to two two grooves 32 of opening 30, but load block 26 can include any amount of groove 32, or More or less than the quantity in the opening 30 for loading the interior formation of block 26.Additionally, each groove 32 can be with any other phase of groove 32 It is same or different.Loading block 26 can include (passing through guiding elements 26b and entering top surface 28 than the multiple tips on delivering axle On tissue substitute implant) more groove 32.Groove 32 can have spacing w2, its be equal between opening 30 away from From so as to groove 32 be alignd with opening 30.As illustrated, each groove 32 is configured to semi-cylindrical otch, they are big Cause is upward through second arm 40 of guiding elements 26a perpendicular to the side of top surface 28.However, groove 32 can have any chi Very little, shape and the surface orientation relative to top surface 28.Groove 32 can have any depth for stretching into guiding elements 40, and this draws Lead component to be configured to provide enough passages, Surigical tool can be guided along the passage.Groove 32 can also have appoints What longitudinal length l5, but they may be constructed such that than be received into it is therein delivering axle tip it is shorter, to allow tip extremely A few part extends along groove 32, and allows the distalmost end of tip to be received into opening 30.As illustrated, groove 32 can be along guiding structure One surface of part 40 extends, and with the longitudinal length l equal with the width of the second arm 40 of guiding elements5, e.g., from about 0.08 inch (2.0mm).
When using, as shown in the one embodiment in Fig. 8, support 10 is connected to delivering axle 12 using block 26 is loaded On tip 20.Support 10 is connected on delivering axle 12 using block 26 is loaded, tip 20 can be set to over the mount 10 Pre-position passes through support 10, and so as to help that support 10 is safely delivered in patient's body, this will hereinafter enter one Step is discussed.Although the purposes for loading block 26 is to combine support 10 and axle 12 description of Fig. 1, those skilled in the art will Know, loading block 26 can be used together with these or any other implant and delivery apparatus.
Prepare support 10 to be connected on delivering axle 12, support 10 can be arranged on the positioning of general plane On the top surface 10 of main body.As discussed above, support 10 can be in the following manner arranged on top surface 28：Branch Living tissue side is provided with frame 10 downwards in face of top surface 28, and another opposite side of support 10 is then upward.Support 10 Can be arranged at any position on top surface 28, but as in the illustrated example, support 10 can be arranged to make it The part on periphery at the terminal edge 28a of top surface 28 (top surface 28 intersects with guiding elements 26b herein) is adjacent Connect the exterior surface 34 of guiding elements 26b.Can also be arranged to make its major axis to be roughly parallel to the longitudinal direction of opening 30 on support 10 Length.So, support 10 can be in desired manner arranged on top surface 28, be located under the top of opening 30 and groove 32 Side, and support 10 extends predetermined length between terminal edge 28a and opening 30, for example, support 10 can be arranged on The longitudinal length l of the second arm 40 under it4。
After support 10 is arranged on demand on the top surface 28 for loading block 26, the tip 20 of axle 12 can will be delivered Support 10 is forced distally towards along groove 32 and through support 10, support 10 is connected thereto.So, each tip 20 can Be imported into support 10, optionally by contribute to be pierced into support 10 tip 20 distalmost end and/or make tip 20 pass through support Hole 10a on 10.Because groove 32 can be axially aligned with opening 30, therefore each tip 20 can be by after through support 10 It is received into one of opening 30.The longitudinal length of tip 20 can be with long enough, to allow tip 20 through the same of groove 32 When at least partially into opening 30.Axle 12 can be stopped mechanism and limit to the movement of distal end, for example one or more openings 30 lower surface and/or the top surface 42 of guiding elements 26b.When distal surface (such as point of the elongate body 18 of axle 12 The surface of first 20 main bodys 18 stretched out from it) contact guidance component top surface 42 when, the top surface of guiding elements 26b 42 can prevent axle 12 from being moved to distal end.Moved to distal end by limiting axle 12 in any one or more of mode, can be by point First 20 push-in support 10 is deep enough so that support 10 can be sufficiently attached on tip 20.
After tip 20 passes through support 10, delivering axle 12 can be separated from loading block 26, and allow support 10 still to connect On delivering axle.Axle 12 can be allowed to be moved to the direction away from top surface 28 along the longitudinal axis A of axle 12, to allow tip 20 Depart from opening 30, so that axle 12 departs from loads block 26.It is optionally possible to by tip 20 towards the direction away from guiding elements 26b Opening 30 is slipped over, to help from removal axle 12 and support 10 on block 26 is loaded, this can help ensure that and is separated from loading block 26 During tip 20, position of the support 10 on tip 20 is constant.For example it is shown in the illustrated embodiment, when opening 30 is by structure Make during for elongated slot, tip 20 can slip over opening 30.Slipped over out towards the direction away from guiding elements 26b by by tip 20 Mouth 30, it is also possible to by support 10 towards the direction movement away from guiding elements 26b, be specifically moved out from the lower section of the second arm 40 It is dynamic, so as to the possibility that support 10 encounters the second arm 40 when top surface 28 is left be minimized.Therefore, tip 20 this Plant to slide and be particularly effective before axle 12 is substantially moved along its longitudinal axis A directions.Additionally, by support 10 generally planar Position in slide (rather than tilt stand 10 avoiding guiding elements 26b from being contacted with support 10) can more carefully manipulate it is easy Broken support 10, and help to keep living tissue over the mount 10.It is optionally possible to slide and lean on axle 12 in opening 30 The second arm 40 to pivot, to lift support 10 while sliding.
As shown in figure 9, after by tip 20, support 10 is connected on axle 12, can be maintained at for support 10 by frictional force On tip 20, until removing support 10 from it untill.Those skilled in the art will be appreciated that, can in several ways by The support 10 being connected on axle 12 is delivered in patient's body lumen.As described above, in one exemplary embodiment, will can connect The delivering axle 12 for having support 10 is arranged in intubation 14, and support 10 is delivered into tissue defect site is transplanted.
Intubation 14 can have sizes, shape and configuration.In the embodiment shown in Figure 10 and Figure 11, intubation 14 has Having longitudinal length L2, and be included in the near-end 14b of intubation 14 has the elongate body 44 of head 46.As illustrated, intubation is thin Main body long 44 can be with substantially cylindrical, but it is also possible to any shape.Elongate body 44 can also have any size, make Obtaining its longitudinal length can allow at least a portion of elongate body 44 to insert patient's body lumen, and at least make the head of intubation 14 46 is external positioned at patient.The inner passage 22 of intubation 14 can longitudinally through elongate body 44, and can have be configured to Allow that any size and shape that axle 12 is arranged slideably therein, such as cylinder will be delivered.Inner passage 22 can have Constant diameter D2, or passage 22 can have variable diameter D2, for example, at least having in the distal portions of elongate body 44 There is larger diameter D2, to help to accommodate axle 12 and support 10.As illustrated, elongate body 44 can have substantial constant Outer diameter D 4, or elongate body 44 distal end 14a can have tapered cone shape, for example distally gradually contract It is small, to help first to introduce in patient's body the distal end 14a of intubation.One or more parts of elongate body 44 and/or head Portion 46 can optionally including one or more grasping mechanisms (such as finger of molding depression, decorative pattern), be conducive to treatment and Manipulate intubation 14.
As described above, axle 12 may be constructed such that being arranged in intubation 14, the elongate body 18 of axle is set slideably to receive To in the inner passage 22 of intubation 14.Therefore, the elongate body 18 of axle can be as shown in this embodiment substantial cylindrical, with Match the shape of the inner passage 22 of intubation.The passage 22 of intubation and the corresponding cylinder form of elongate body 18 of axle can be with Internally passage 22 is interior while carrying out linear and rotary motion, this can help to for support 10 to be positioned at defect portion to allow axle 12 Position, this is discussed more fully below.Therefore, the elongate body 18 of axle can have the diameter D2 of the inner passage 22 than intubation Less diameter D1, to allow the elongate body 18 can be in slotting in-pipe.
Illustrated header 46 is located at the most proximal end of intubation 14, but head 46 can also be located at any position on cannula proximal end 14b Put.For non-limiting examples, head 46 can be substantially as depicted cylindrical, but those skilled in the art will Will appreciate that, head 46 can have any size, shape and configuration.Head 46 can serve as shank, and it is configured to allow for Patient's manipulated in vitro intubation 14.As illustrated, the diameter D5 of head 46 can be more than the diameter D4 of elongate body 44, this can be helped Serve as shank in head 22, and help to provide locking device, the locking device is configured to releaseably will delivering Axle 12 is maintained at position fixed in passage 22.
The locking device of intubation can have various shapes, size and configuration, but be generally configured to special with the locking of axle Levy 24 complementary and effective to its, so that axle 12 is releaseably locked in intubation 14.In the embodiment shown, intubation Locking device include be connected to bearing pin 50 and spring 48 intubation 14 head 46 button 52.Head 46 can have at it The opening 54 that side is formed so that opening 54 connects with the passage 22 through intubation 14.Button 52 can stretch into head through opening 54 Portion 46, makes the distal end 52a of button 52 be located in head 46, and the near-end 52b of button 52 is located at outside head 46.Spring 48 can be with It is arranged in head 46, and button 52 is biased towards passage 22.Bearing pin 50 can pass through the hole 56 that is formed in the head 46 and The hole 58 formed in button 52, button 52 is maintained in opening 54.Hole 58 in button 52 can have than bearing pin 50 The bigger diameter of diameter so that in the case where the spring load of button 52 coordinates, when button 52 is pressed button 52 can be allowed relative Moved in bearing pin 50 and head 46.So, it is unimpeded in passage 22 when button 52 is in the unlocked position being pressed, so that Surigical tool can wherein slidably.When button 52 is in acquiescence latched position, the locking member 52c of button 52 The Surigical tool being arranged in the passage 22 of head 46 can be contacted, by Surigical tool locking wherein, until Untill button 52 is moved into unlocked position.Diagram locking member 52c is the cross bar with the projection 52d being formed on.Can The lock feature of engagement axle 12 is may be constructed such that with the inner surface of the locking member 52c with any size, shape and configuration 24, and projection 52d then may be constructed such that and spring 48 is kept alignment.
As set forth above, it is possible to the axle 12 that will be connected with support 10 in several ways pushes intubation 14.In showing shown in Fig. 1 In example property embodiment, the near-end 12b of axle 12 can first be pushed the distal end 14a of intubation 14, to help to shorten to greatest extent The length of the passage 22 that support 10 is passed through, so as to contribute to reduction support 10 to lose living tissue possibility because scraping passage 22 Property, and help to reduce the possibility that support 10 surprisingly comes off because encountering passage 22 from tip 20.Although can be by axle 12 are inserted directly into intubation 14, but in the exemplary embodiment, axle 12 can be pushed the funnel being connected on the distal end 14a of intubation 14 16.Funnel 16 is constructed with conical internal cavity or passage, plane configuration by support 10 from tip 20 (for example, The folding configuration on the tip 20 in intubation 14 is moved to as shown in Figure 9), and this will be discussed further below.
Funnel 16 can have sizes, shape and configuration.In the exemplary embodiment shown in Figure 12 and Figure 13, leakage Bucket 16 includes elongate body, and the elongate body has the inner chamber or passage 60 extended between its distal end 16a and near-end 16b.Leakage Bucket 16 can have any longitudinal length L6 (such as from about 2.36 inches (59.9mm)), can shift its any length onto intubation 14 On.Passage 60 can have an any shape, the shape of such as substantial cylindrical, to allow the shape and cannula passage of hopper channel 60 22 is corresponding.Passage 60 can have variable diameter so that passage 60 is more than passage 60 in the diameter D6 of its distal portions 60a In the diameter D6 of its proximal part 60b, and funnels 16 of the diameter D6 between distal portions 60a and proximal part 60b Proximally direction is gradually reduced portion 60c.Distal portions 60a and proximal part 60b can have any longitudinal length, for example, Distal portions 60a has the length L7 of about 0.54 inch (13.7mm), and proximal part 60b has about 1.5 inches (38.1mm) Length L8.Diameter D6 of the passage 60 in the proximal part 60b of funnel 16 can be slightly larger than intubation 14 at least in intubation 14 Outer diameter D 4 at the 14a of distal end, to allow the near-end 16b secure fits of funnel 16 to the distal end 14a of intubation 14 (such as Fig. 1 institutes Show) so that the passage 60 of funnel and the passage 22 of intubation can communicate with each other, and can therebetween provide smooth mistake Cross.The size of the diameter D6 of hopper channel 60 can change, such as can be than proximal part 60b places about at distal portions 60a It is big by 2/3 so that diameter D6 is (such as) about 0.575 inch (14.6mm) at distal portions 60a, is at proximal part 60b About 0.377 inch (9.6mm).The outer diameter D 7 of the elongate body of funnel can change, for example, being for about at distal portions 60a 0.688 inch (17.5mm), is for about 0.48 inch (12.2mm) at proximal part 60b, or can also be substantial constant 's.Although funnel 16 can be made up of any combinations of rigid material and/or flexible material, in the exemplary embodiment, leakage Bucket 16 is made up of one or more generally rigid material (such as medical grade polycarbonate).
When using, funnel 16 can be connected to the distal end 14a of intubation 14, and axle 12 is slideably received into wherein. After first by the distal end 14a of the distal end 16a of the near-end 12b push-in funnels 16 of axle 12 and intubation 14, tip 20 can be axle 12 The last part of upper entrance funnel 16 and intubation 14.Due to that tip 20 can be pushed into support 10, and it is set to arrive support 10 Edge is preset distance (such as length l4), therefore tip 20 can be positioned relative to support perimeter, passed through to work as support 10 Support 10 is moved into folding configuration from plane configuration in a desired manner during funnel 16 so that support 10 can have in intubation 14 There is folding configuration.In other words, the tapered passage 60 of funnel 16 can form folding configuration with guide support 10, be propped up under the configuration Frame 10 is wrapped in around tip 20, for example, as shown in figure 14.Those skilled in the art will be appreciated that, under folding configuration, can To allow support 10 to roll (as shown in the figure) and/or corrugation.Further, since support 10 can be ellipse, it is possible to organize it Side 10b is loaded on tip 20 (for example, as shown in Figure 9 away from the elongate body 18 of axle) down, and makes tip 20 along support 10 major axis is in asymmetric position, therefore support 10 can be folded into U-shaped around tip 20, and makes tissue sides 10b faces To tip 20.So, when being connected with the axle 12 of support 10 and being slipped over from the passage 22 of intubation 14, can be in intubation 14 more preferably The tissue sides 10b of ground protective cradle 10.
Axle 12 can be pushed any distance in intubation 14, support 10 is fully accommodated in the passage 22 of intubation. In one exemplary embodiment, the locking device coordinated between axle 12 and intubation 14 can allow for axle 12 to push intubation 14 pre- Set a distance, to help to ensure the tip 20 for being connected with support 10 completely and be safely accommodated in intubation 14.As above begged for Opinion, locking device can have various configurations, but in the diagram embodiment, button 52 in the head 46 of intubation 14 can be with Engaged with the groove 24 formed in axle 12, axle 12 is maintained at latched position in intubation 14.When axle 12 through intubation 14 During passage 22, button 52 can be moved to depressed position by axle 12 from offset position.Can through the passage 22 in head 46 by axle 12 To allow button 52 to be maintained at depressed position, make axle 12 through being formed the distal end 52a and near-end 52b of button 52 through pressing The opening of button 52, untill groove 24 reaches button 52.When axle 12 passes through the enough distances of passage 22, reach lock feature 24 At button 52 so that when lock feature 24 and button 52 align, button 52 can slip into groove 24, for example, locking member 52c Inner surface can be engaged with groove 24.Therefore, groove 24 (has smaller than the elongate body 18 that groove is formed wherein straight Footpath) can aid in and promote button 52 to be changed into latched position from unlocked position, so as to axle 12 is maintained at into fixed position, until Pressed at the near-end 52b of button 52 and/or be distally advanced axle 12 so that its conical by its shape can be by lock feature 24 Depart from the locking device of intubation.At latched position, at least the near-end 12b of axle 12 can stretch out the near-end of intubation 14 to nearside 14b, so that allow when intubation 14 is introduced in patient's body can be from intubation 14 is outer and patient's manipulated in vitro axle 12.In addition in locking bit Put down, can will be connected with the tip 20 of support 10 and be arranged in the distal portions of intubation 14 proximal end for just arriving funnel 16. Therefore, in the embodiment shown, pushing elongate body 18 to distal end can be in the case where hand push button 52 not be needed by part Unblock.The rigidity of spring 48 and the slope of taper may decide that to be needed to produce great power to carry out unlocking feature, to help to prevent Elongate body 18 comes off outward from intubation 14 is favorite.
After axle 12 and support 10 are loaded into intubation 14 from behind, it is possible to which intubation 14 is inserted into tissue.This area Technical staff will be appreciated that, support 10 or any other tissue substitute implant can be introduced into patient's body by any mode It is interior.In the one embodiment shown in Figure 15, can be incited somebody to action by the otch formed in tissue 64 by surgical operation or opening 62 Intubation 14 inserts body cavity, to prepare to be delivered to support 10 in patient's body.Before intubation 14 is inserted into the patient, Ke Yicong Funnel 16 is removed on the distal end 14a of intubation 14, this can help to reduce the size of opening 62.Although being initially charged into group as shown in the figure It is the intubation 14 for being provided with axle 12 to knit 64, but those skilled in the art will be appreciated that, it is also possible to be not provided with axle 12 Intubation 14 is penetrated into tissue 64 in the case where cannula passage 22 is interior, if for example branch will be connected with by the near-end 14b of intubation The axle 12 of frame 10 introduces intubation 14.Those skilled in the art will also be appreciated that, can be as shown in the figure by intubation 14 directly through group 64 are knitted, to help at utmost to reduce the size of opening 62, or intubation 14 can be inserted by guiding device, it is described to draw It is, for example, the inlet port with the service aisle that can therefrom push another surgical operating instrument to lead device.
Those skilled in the art will be appreciated that, the distal end 14a of intubation 14 can aid in form opening 62 and/or can be with Formed through the opening 62 of tissue 64 with one or other Surigical tools.When the elongate body 44 of intubation passes through opening 62 When, it can be by the diameter D4 of the elongate body 44 of the enlarged-diameter of opening 62 to about intubation, so as to contribute at utmost Reduce the size of opening 62 and mitigate patient trauma.Due to that support 10 can be disposed entirely within intubation 14 with folding configuration, because This can be inserted into the patient less than the diameter of support 10 or the opening 62 of Breadth Maximum from diameter by it.
Intubation 14 can be longitudinally propelling any distance through tissue 64, it is possible to be set by any way relative to tissue 64 Put.Intubation 14 can also at the defect for wanting connecting bracket 10 relative to tissue (such as cartilage 68) in formed cavity 66 with Any mode is set.In the exemplary embodiment, intubation 14 can be arranged through tissue 64 so that the longitudinal axis of intubation 14 The longitudinal axis A of line A2 (referring to Figure 10) and axle 12 is each substantially perpendicular to cavity 66.This substantially vertical set-up mode can have Help from patient it is external faster, safer, relative to cavity 66 support 10 more accurately is set.
Once by intubation 14 through tissue 64, the elongate body 44 of (such as) intubation is arranged in opening 62, intubation Distal end 14a and head 46 are located at the opposition side of tissue 64, it is possible to be distally advanced delivering axle 12, pass through the passage of intubation 22 and the distal end 14a of intubation is stretched out, and/or can proximally shrink intubation 14, to expose support 10 and be delivered to support 10 In patient's body.As shown in the one embodiment in Figure 16, in the central longitudinal axis A and intubation 14 of delivering axle 12 that can align Heart longitudinal axis A2, makes it be approximately perpendicular to required position (such as top of cavity 66).Although by support 10 push and through insert During pipe 14 can delivering axle 12 and intubation 14 be disposed relative to required position Anywhere, but this substantially vertical set The mode of putting allows for support 10 to be more accurately delivered to required position, such that it is able to reduce displacement, and by frangible support 10 Set in vivo.Axle 12 can be pushed in the passage 22 in intubation 14 to distal end by any mode, for example, by by axle 12 The position being basically unchanged is maintained at, and moves proximally to intubation 14, or as shown in the figure, be maintained at by by intubation 14 The position being basically unchanged, and to distal end shifting axle 12, pass through the passage 22 of intubation 14.In the embodiment shown, axle 12 to When distal end is moved, locking device is automatically separated, but alternatively or additionally, it is also possible to manual separation locking dress (for example, by pressing the button 52 on intubation head 46) is put, to allow axle 12 interior slidably in intubation 14.
When outside support 10 to be arranged on the distal end 14a of intubation 14, support 10 can be moved, make it extensive from folding configuration Plane configuration is arrived again.Those skilled in the art will be appreciated that, when to distal end gradually roof support 10, it is exceeded the remote of intubation During the 14a of end, support 10 can be gradually moved into plane configuration (as shown in figure 17) by folding configuration (as shown in figure 16).Support 10 can be made up of the material for making support 10 be automatically moved to folding configuration from plane configuration, but can optionally use at least one Individual grasper and/or delivering guider are firmly grasped or aid in launching support 10, and this will be discussed further below.
When beyond support 10 is arranged on the distal end 14a of intubation 14, support 10 can be separated from the tip 20 of axle 12, And be disposed in cavity 66 to be connected thereto.Can be by positioning of the support 10 in cavity 66 and/or surgical operation Any other part is visualized, for example, being observed by the lens on Optical devices inserted into the patient, and is being suffered from Taken pictures on the external visualization screen of person.Although support can be removed from tip 20 when axle 12 is arranged in intubation 14 10, but in the exemplary embodiment, intubation 14 can be removed from patient's body before support 10 is separated with delivering axle 12.Such as Shown in one embodiment of Figure 17, intubation 14 can be removed from patient's body, and by support 10 and at least a portion of axle 12 Stay in patient's body.Intubation 14 can be removed from patient's body by any mode, such as by catching axle 12 in vitro, and Intubation 14 is moved proximally to as shown in the directional arrow of Figure 17 to be removed from patient's body with by it.If locking device is not by structure Make to move proximally to be automatically separated during intubation 14, to allow the locking mechanism 24 of axle through the locking device of intubation, then Can be with manual separation locking device (such as pressing button 52).It is optionally possible to tip 20 is set in the bottom of cavity 66 Surface contiguous bone and/or calcified cartilage, to make axle 12 keep stabilization when removing intubation 14 from the surrounding of axle 12.
Support 10 can be removed from tip 20 by any mode, for example, catch support 10 with grasper, and it is mobile Axle 12 and/or grasper, support 10 is removed from tip 20.Alternatively or additionally, it is possible to use Surgical operating instrument removes support 10 from tip 20, and the surgical operating instrument is configured to be advanced in the top of axle 12, And it is configured to help to be attached in support 10 in cavity 66, so that number of instruments used in reducing surgical procedures, And improve the implantation precision of support.This surgical operating instrument can have various configurations, for example, passing as shown in Figure 18-23 Send one embodiment of guider 70.Generally, delivering guider 70 may be constructed such that：Removed from the tip 20 of delivering axle 12 Support 10, fixed position is kept by support 10 at required implant site, and in the case of without being removed from patient's body, To be configured to contribute to one or more surgery devices of attachment bracket 10 to guide to required implant site.Therefore, pass Send efficiency that guider 70 is favorably improved surgical operation, limit the movement of frangible support 10, and help to ensure support 10 are attached at the required position in patient's body.
Delivering guider 70 can have sizes, shape and configuration.As shown in this embodiment, delivering guider 70 is wrapped Elongate body 72 is included, the elongate body 72 has the inner chamber or passage extended between the distal end 70a and near-end 70b of guider 70 76, and the bone engagement element 74 at the distal end 70a of delivering guider 70 is located at at least one.Delivering guider 70 can With with any longitudinal length L9, e.g., from about 7.2 inches (182.9mm).In the exemplary embodiment, delivering guider 70 can With shorter than delivering axle 12, to allow to be arranged on axle 12 in passage 76, and proximally stretch out outside the near-end 70b of guider, make Obtaining when axle 12 is arranged in guider 70 can more easily manipulate the axle.The longitudinal length L9 of guider 70 can also be enough It is long, to allow be directed to (such as shown in Figure 26 hereinafter described) when device 70 is set through tissue surface, make its distal end 70a With the opposition side that near-end 70b is arranged on tissue surface.
Elongate body 72 can optionally include one or more grasping mechanisms, such as finger ring, finger chase, the decorative pattern of molding Deng to be conducive to grasping and manipulating guider 70.Alternatively or additionally, guider 70 can be wrapped optionally Shank is included, the shank is located at the other parts of guider near-end 70b and/or elongate body 72.For non-limiting examples, Shank can be the disk or knob of substantial cylindrical, but those skilled in the art will be appreciated that shank can have to be allowed Any size, shape and the configuration of guider 70 are caught in vitro.Those skilled in the art will be appreciated that guider 70 need not Including shank, but can instead be manipulated using the proximal part of (such as) elongate body 72.
One or more bone engagement elements 74 positioned at guider distal end 70b generally may be constructed such that through support 10, and/or bone and/or calcified cartilage are partially through, to help to be with or without surgery hand in the passage 76 of guider It is directed to that device 70 (and then by support 10) is close to bone and/or calcified cartilage is fixed in the case of art device.Bone engagement element 74 can have any configuration.In the embodiment shown, guider 70 includes four bone engagement elements 74, but guider 70 can With including any amount of bone engagement element 74, such as two.Additionally, each bone engagement element 74 can with it is any its His bone engagement element 74 is identical or different.Bone engagement element 74 may be constructed such that dentation or tip as depicted, and And with or without tapered distal end top, the distal tip be configured to contribute to bone engagement element 74 engage bone and/ Or calcified cartilage.The bone engagement element 74 of diagram is about 0.06 inch of height 74h (1.5mm), about 0.03 inch of length 74l The isosceles triangle of about 0.01 inch of (0.75mm), thickness (0.25mm), but bone engagement element 74 can have any size And shape.Bone engagement element 74 can be arranged at the 70a of guider distal end with any configuration, such as along guider peripheral radial etc. Spacing it is arranged in around the central longitudinal axis A3 of guider 70, as shown in figure 23.Bone engagement element 74 can substantially put down Row extends in the longitudinal axis A3 of guider, or as illustrated, bone engagement element 74 can radially be inclined with angle [alpha], To help preferably to clamp bone and/or calcified cartilage.In some embodiments for including multiple bone engagement elements 74, Bone engagement element 74 can cover the distal surface of elongate body 72 so that bone engagement element 74 (such as many teeth) can be with Form the bone engagement surface of veining.
Although shown bone engagement element 74 is integrally formed with elongate body 72, in bone engagement element 74 Any one or more can be removably couplable in elongate body 72.For non-limiting examples, bone engagement unit Part 74 can be telescopic so that in extended position, bone engagement element 74 can stretch out the distal end of guider to distal end 70a, and in advanced position, it can be contained in elongate body 72.It should be known to those skilled in the art that can be with any Mode controls retraction and the elongation of movable bone engagement element, for example, controlled by starting the place of the near-end 70b of guider 70 Mechanism's (such as knob, button, control-rod, electronic signal communication device).In certain embodiments, bone engagement element 74 can Releasably it is connected on guider 70.
As described above, guider 70 may be constructed such that be detachably connected on axle 12, make the elongate body 18 of axle can It is slidably received in the inner passage 76 of guider 70.Therefore, as shown in this embodiment, the passage 76 of guider can be big Cylinder is caused, so that the shape with axle 12 matches.The cylinder that the elongate body 18 of guide channel 76 and axle matches Shape causes that axle 12 internally can not only carry out linear movement but also can be rotated in passage 76, and this will be helpful to relative to axle 12 Guider 70 is set with the support 10 being connected on the tip 20 of axle 12.Therefore, the diameter D1 of the elongate body 18 of axle can be with small In the diameter D8 of the passage 76 of guider, so that elongate body 18 can be with movable within.Diameter D8 can have any size, E.g., from about 0.305 inch (7.7mm).Elongate body 72 can also have any shape (such as cylinder), and can have Any diameter D9, e.g., from about 0.375 inch (9.5mm).The diameter D9 of elongate body can be along the longitudinal length L9 of guider 70 Keep constant, or diameter D9 can also change, for example, elongate body 72 has difference at least a portion of distal end 70a Diameter D9.
Elongate body 72 can also include one or more windows or otch 78 near distal end 70a.Guider distal end 70a One or more windows at place are optional, and they may be constructed such that and allow to be located at least in observation guide channel 76 At least one surgical operating instrument and/or surgical site at the 70a of distal end.Opening 78 can have any configuration.Such as this Shown in embodiment, otch 78 can include one or more holes formed in the side wall of the elongate body 72 of guider 70 or open Mouthful so that otch 78 is connected with the passage 76 of guider.Although showing four otch 78, guider 70 can include any The otch 78 of quantity.Additionally, each otch 78 can be identical or different with any other otch 78.Shown otch 78 be with The rectangle of the length 78l of about 0.375 inch (9.5mm) and the width 78w of about 0.18 inch of (such as) (4.8mm), but otch 78 Can have any size and shape.Otch 78 can be arranged at the distal end 70a of guider with any configuration, such as between radially waiting It is arranged in around the central longitudinal axis A3 of guider 70 away from ground, for example, is spaced about 90 ° as shown in the figure.Window 78 can be arranged on With the distalmost end of guider 70 at a distance of any fore-and-aft distance 78d (e.g., from about 0.05 inch (1.3mm)) place, to allow observation to be oriented to Part in the distal end 70a of device 70 in passage 76.
In the alternate embodiment of delivering guider 70' as of fig. 24, device 70' can be directed to and be configured to and guiding The similar shape of device 70, the difference is that the window for being close to distal end 70a' formation can be the saturating of the elongate body 72' of guider 70' The form of bright part 72t.Transparent part 72t may be constructed such that to be allowed to be observed through guider 70', while helping to prevent group Knit, fluid and any other material enter the inner chamber 76' of guider 70' through elongate body 72' sides.Although shown transparent part 72t is located only within the distal end of elongate body 72', but transparent part 72t can be along any all or part of long of elongate body 72' Degree extends.The transparent part 72t in distal end can be continuous transparent part, for example, shown transparent cylindrical body, but this area Technical staff will be appreciated that the transparent part in distal end can include multiple transparent windows, and these windows are in elongate body 72' Formed and be arranged in around it, and similar to otch 78.Those skilled in the art will also be appreciated that, as the term is employed herein " transparent " is intended to include one or more any combinations of transparent material, including optically transparent material and trnaslucent materials.
As described above, bone engagement element with delivering guider in addition to being integrally formed, can be with detachably connected Onto guider.Substitute guider 70' and one or more bone engagement elements 74' of extension from distal loop 71 to distal end is shown One embodiment, the distal loop 71 is configured to be detachably connected in any mode known to those of skill in the art The distal end 70a' of guider, such as threaded connection, snap-fitted etc..So, bone engagement element there can be different size Delivering guider is connected to shape and/or distal loop with varying number, size, shape etc., to cause delivering guider The tissue defect site of different sizes and shapes and the organization bracket of different sizes and shapes can be better adapted to.Modularization Distal loop can be optionally provided with the delivering guider as an external member part.
In the delivering guider 70 shown in Figure 25 " another alternate embodiment in, device 70 can be directed to " be configured to Guider 70 or the similar shapes of guider 70', " at least one registration mechanism, this pair can be included the difference is that guider 70 Neat mechanism is configured to that inner chamber or passage 76 will be inserted " instrument (such as delivering axle, perforating tool, fastener applying instrument) set Put relative to guider 70 " predetermined radial position, the wherein distal end (not shown) of inner chamber or passage 76 " in guider 70 " And near-end 70b " between extend.So, even if it is difficult to or instrument (such as small invasive surgical at surgical site cannot be seen Situation about being frequently encountered in operation), it is also possible to know the instrument in the position of surgery surgical site.Optional registration mechanism can With with sizes, shape and configuration.For non-limiting examples, registration mechanism can include printing, impressing or with other The Surigical tool that visual way is in guider 70 " the upper alignment for being formed is oriented to label, and the label shows insertion passage 76 " Correct radial position.The Surigical tool can have corresponding alignment to be oriented to label so that can align the right of matching It is neat to be oriented to label, it is " interior to be properly positioned the instrument to help to ensure in guider 70.In the embodiment shown, registration mechanism bag Include at least one elongated slit 80 formed in guider 70 " at least near-end 70b ".The near-end of insertion guider 70 " The Surigical tool of 70b " can have one or more corresponding registration mechanisms (such as bearing pin, projection, elongated track), this A little registration mechanisms are configured to be received into slit 80 and slide wherein, by the tool orientation to specific radial position Put so that even if vision judgement cannot be carried out, it is also possible to know its in guider 70 " the position of far-end.
No matter which kind of delivering guider is introduced to aid in removing support 10 from the tip 20 of delivering axle 12 in patient's body, Delivering guider can be introduced in patient's body from the top of axle 12.In the embodiment shown in Figure 26 and 27, set when by axle 12 It is set to when the opening 62 in 64 is organized, the distal end 70a of guider 70 can be delivered and preceding push through the top of axle 12 so that axle 12 Can be slidably received into the passage 76 of guider.In the distal end 70a and the support 10 being connected on tip 20 of guider Before contact whenever, support 10 can be arranged on the top of cavity 66 and be alignd (as shown in figure 26) with cavity, make Support 10 must be distally advanced can be arranged in cavity 66 (as shown in figure 27) support 10.Tip 20 can be set to At least one surface of the bottom surface contact bone 67 of cavity 66, so that position of the support 10 relative to cavity 66 is set, and Axle 12 is set to keep stabilization in the top of the elongate body 18 propulsion guider 70 of axle 12.As described above, tip 20 can be to distal end It is gradually reduced, this will be helpful to tip 12 promptly and/or through bone 67.In addition, alternatively or additionally, Bone 67 can include calcified cartilage.
As shown in the directional arrow in Figure 26, delivering guider 70 can be distally advanced from the top of axle 12, and make to lead The support 10 on tip 20 is finally contacted to the distal end 70a of device.Because guider 70 may be constructed such that around axle 12, guider 70 distal end 70a can be distally advanced from the top of axle 12 (and then from above tip 20 of projecting shaft 12), and not contact point Support 10 is contacted in the case of first 20.Delivering guider 70 can be organized 64 to distal end push-in, until the distal end of guider 70 Untill support 10 is pushed cavity 66 by 70a, so support 10 optionally can also be moved into plane configuration from folding configuration.Bone Bone piercing elements 74 can pass through support 10 and contact at least one surface of bone 67, and this will be helpful to that guider 70 will be delivered The correct position in patient's body is maintained at, and support 10 is temporarily kept in the fixed position in cavity 66.The skill of this area Art personnel will be appreciated that, one or more bone piercing elements 74 may be constructed such that and be not passed through support 10, from without contact bone Bone 67.When in the required position during support 10 is maintained at cavity 66 by guider 70, can be from guider 70 and patient's body Remove axle 12.Axle 12 can be removed by any mode, for example, as shown in figure 27, manipulating proximally direction and stretching out guider The near-end 12b of the axle 12 outside near-end 70b, and proximally pull axle 12.Allow guider 70 towards the movement of support 10 by support 10 push away one or more tips 20, but if certain tip 20 is worn after be maintained at for support 10 in cavity 66 by guider 70 Support 10 is crossed, is then moved proximally to axle 12 and is passed through the passage 76 of guider, it is possible to tip 20 is extracted from support 10.
Optionally, when support 10 is in the implantation position in cavity 66, support 10 can be connected to patient. Those skilled in the art will be appreciated that the support 10 in implantation position can completely fit in cavity 66, or when (example When such as) support 10 is cut into the size bigger than cavity 66, a part of of support 10 can be stretched out outside cavity 66.This area Technical staff will be appreciated that, support 10 can be connected to patient by any mode.In certain embodiments, it is being oriented to Device 70 pushes support 10 after implantation position, and guider 70 can be removed from patient, but in an exemplary embodiment In, when the passage 76 of at least one Surigical tool push-in guider so that support 10 is attached to patient, it is oriented to Device 70 remains in that original position.
Can by any mode using any one or more Surigical tools come attachment bracket 10.In Figure 28-31 In shown one embodiment, can be with bone preparation tool (such as perforating tool 82) in support 10 and below support 10 Bone 87 in pass at least one hole or opening 86, and can use the support instrument in place (such as fastener apply instrument 88) will At least one fixed mechanism or fastener 90 pass through one or more openings 86 formed by perforating tool 82, to secure the stand to On bone 87.In certain embodiments, individual tool can be configured to bone preparation tool and support instrument in place (such as staple Insertion apparatus), such as those devices discussed in detail in above-mentioned following patent：The announce, title on the 10th of September in 2002 It is " Instrument For Inserting Graft Fixation the Device " (device for inserting graft fixation device Tool) United States Patent (USP) No.6,447,517；On January 30th, 2001 announces, entitled " Graft Fixation Device The United States Patent (USP) No.6,179,840 of And Method " (graft fixation device and method)；And on July 23rd, 2002 announces , entitled " Instrument For Inserting Graft Fixation Device " (is fixed for inserting graft The apparatus of device) United States Patent (USP) No.6,423,073.Perforating tool 82 and fastener apply instrument 88 can individually be pushed Support 10 is fixed on the delivering guider 70 in cavity 66 such that it is able to which it is relative that perforating tool 82 and fastener are applied into instrument 88 More accurately set in support 10, and help to ensure that one or more fasteners 90 for applying the applying of instrument 88 with fastener are set At the required position relative to support 10, and ensure one or more fasteners 90 with one or more openings 86 for being formed Correct alignment.Those skilled in the art will be appreciated that, if when support 10 is applied by any way in both uses one Person or another one, then can use other bone preparation tools and support instrument in place.For non-limiting examples, fastener Can be drawn from bone 87, then pass through support 10.
Perforating tool 82 can have sizes, shape and configuration.Those skilled in the art will be appreciated that, generally wear Hole instrument 82 can include any perforator for being configured to form one or more openings or hole in organization bracket and bone Tool.The non-limiting example of perforating tool is found in the following patent for being incorporated by this paper：In September, 2002 Announcing, entitled " Instrument For Inserting Graft Fixation Device " was (for inserting shifting on 10th The apparatus of device for fixing plant) United States Patent (USP) No.6,447,517；On January 30th, 2001 announces, entitled " Graft The United States Patent (USP) No.6,179,840 of Fixation Device And Method " (graft fixation device and method)；And That on July 23rd, 2002 announces, entitled " Instrument For Inserting Graft Fixation Device " (is used In insertion graft fixation device apparatus) United States Patent (USP) No.6,423,073.In the one embodiment shown in Figure 28, wear Hole instrument 82 can include having the elongate body of at least one bone preparation element 85 of the distal end 82a positioned at perforating tool 82 83.Perforating tool 82 can have any longitudinal length, but in the exemplary embodiment, perforating tool 82 can be oriented to than delivering Device 70 is grown, so as to when the distal end 70a of guider 70 and the distal end 82a of perforating tool 82 contact the support 10 in patient's body, Allow to be arranged on perforating tool 82 in passage 16, and to proximally stretching out the near-end 70b of guider.Bone piercing elements 85 can With with any size, shape and configuration.Similar to bone engagement element 74 discussed above, bone piercing elements 85 can be big Cause is configured to dentation or tip, and these dentations or tip are configured at least partially penetrate bone, to contribute in bone Middle formation hole or opening.The bone piercing elements 85 of perforating tool 82 can be different from the bone engagement element 74 of guider 70, It is more acute and/or longer for example than its, suitable hole can be formed in bone with the bone piercing elements 85 for allowing perforating tool 82 To receive fastener.As illustrated, the bone piercing elements 85 of perforating tool 82 can be cylindrical rigid solid component.
As described above, perforating tool 82 may be constructed such that being detachably connected on guider 70, make perforating tool Elongate body 83 is slideably received into the inner passage 76 of guider 70.Therefore, as shown in this embodiment, perforating tool Elongate body 83 can be matched with substantially cylindrical with the shape with inner passage 76.The passage 76 of guider and perforator The corresponding cylinder form of elongate body 83 of tool can allow perforating tool 82 internally in passage 76 and meanwhile carry out it is linear with Rotary motion, unless there is registration mechanism (such as one or more bearing pins 87) so that perforating tool 82 cannot be in guider 70 Passage 76 in rotation.Therefore, the elongate body 83 of perforating tool can have the diameter D8 of the inner passage 76 than guider Less diameter D10, to allow elongate body 83 movable within.Conversely, the near-end 82b of perforating tool can have than being oriented to The diameter D8 and elongate body diameter D10 of device passage 76 bigger diameter D11.So, the near-end 82b of perforating tool can serve as Stop mechanism, it is configured to limitation perforating tool 82 and stretches into guider 70 simultaneously and then be pierced into the distance of bone.
Although perforating tool 82 can be solid component as depicted, perforating tool 82 can also include one or many The individual passage for being formed wherein.For non-limiting examples, perforating tool 82 can include running through its distal end 82a and near-end The passage of 82b, the passage is configured to receive at least one surgical operating instrument for passing through setting, and being such as configured to can be by The vacuum plant that body fluid, tissue etc. are suctioned out from operative site.
When using, as shown in figure 29, perforating tool 82 can to distal end push-in delivering guider 70, and through tissue 64 in Opening 62, until perforating tool 82 distal end (not shown) contact support 10 or otherwise advantageously set up relative to branch Put.Observed with sensation and/or through the otch 78 in guider 70, can confirm that perforating tool 82 is correct in guider 70 Positioning.If perforating tool 82 and guider 70 include registration mechanism, then can before by perforating tool push-in wherein and/ Or with registration mechanism perforating tool 82 is alignd relative to guider 70 afterwards, so as in desired manner by the distal end of perforating tool Alignd relative to support 10, so as to set the opening 86 formed with perforating tool 82 in desired manner.Registration mechanism can also be by The bone piercing elements 85 of perforating tool 82 are aligned in predetermined radial position relative to guider 70.Generally, perforating tool is worked as It is once or many with the near-end 82b that hammer 84 beats perforating tool 82 by (such as) after 82 are arranged in the passage 76 of guider It is secondary, perforating tool 82 can be distally advanced, to form one or more in the bone 87 in support 10 and below support 10 Opening 86.Perforating tool 82 is optionally used, but because bone 87 may be very rigid, forms one or more through support 10 And can be more prone to applying one or more fasteners 90 into the opening 86 of bone 87.Formed as needed in perforating tool 82 Opening 86 after whenever, perforating tool 82 can be moved proximally to by (such as), pass through and leave guider 70, to remove perforating tool 82 from patient's body.When perforating tool 82 is removed, guider 70 can be applied to distal end to press Power, so as to support 10 be held in place.
As shown in one embodiment of Figure 30, from guider 70 after removal perforating tool 82, similar to perforating tool 82, fastener can be applied instrument 88 to distal end push-in delivering guider 70, and pass through the opening 62 in tissue 64.With sense Feel and/or observed through the otch 78 in guider 70, equally can confirm that fastener applying instrument 88 in guider 70 just It is determined that position.If there is registration mechanism, it is also possible to fastener similarly is applied into instrument 88 relative to guider 70 with registration mechanism Alignd with support 10.Perforating tool 82 and fastener apply instrument 88 can be similarly configured to registration mechanism so that be worn Hole instrument 82 and fastener apply pre-position of the instrument 88 in guider 70 and have similarly radially to be orientated so that use fastener The leg of the fastener 90 that applying instrument 88 applies can stretch into the hole 86 formed with perforating tool 82.Therefore, need not (such as) In the case of seeing or otherwise confirming that fastener applies position of the instrument 88 in patient's body, registration mechanism can help to really Fastener applying instrument 88 is protected to be arranged to carry out one or more of fasteners 90 through the hole 86 formed with perforating tool 82 Apply.Fastener can be activated by any mode and apply instrument 88, to apply one or more fasteners.Those skilled in the art It will be appreciated that, fastener applies instrument 88 can be included being configured to one or more fasteners can be applied into appointing on organization bracket What fastener applies instrument.Generally, fastener applies instrument 88 can have at least one to be located at the button that fastener applies the distal end of instrument 88 Part holding member, and be configured to keep at least one fastener with fastener holding member, and at least one fastener is passed through into branch Frame 10 is applied on the bone 87 of the lower section of support 10.The non-limiting example of fastener applying instrument is found in and was above referring to Following patents：Announce, entitled " the Instrument For Inserting Graft Fixation on the 10th of September in 2002 The United States Patent (USP) No.6,447,517 of Device " (apparatus for inserting graft fixation device)；On January 30th, 2001 announces , the United States Patent (USP) of entitled " Graft Fixation Device And Method " (graft fixation device and method) No.6,179,840；And the announcement of on July 23rd, 2002, entitled " Instrument For Inserting Graft The United States Patent (USP) No.6,423,073 of Fixation Device " (apparatus for inserting graft fixation device).Applying one After be connected to support 10 on bone 87 by individual or multiple fasteners 90, fastener can be applied by instrument 88 and guiding by (such as) Device 70 is moved proximally to together or individually, passes through and leave the opening 62 in tissue 64, and fastener is applied into instrument 88 Removed from patient's body with guider 70.
Although Figure 31 illustrate only an X-shaped fastener 90 that support 10 is connected to patient, but it is also possible to use any number Be attached to support 10 in cavity 66 by the fastener 90 of amount.Those skilled in the art will be appreciated that, although shown fastener 90 is seam Nail, but can include one or more fastener of type for support 10 to be connected to one or more fasteners of patient, for example, Any combination of staple, tissue hobnail, suture, binding agent etc..Delivering guider 70 can reset relative to support 10 One or many, it is extra to be conducive to passing one or more in the support 10 using the perforating tool through guider 70 Hole, and be conducive to applying one or more extra fasteners using the fastener applying instrument through guider 70, pass through institute State one or more extra holes.
Device as herein described can be made of any combinations of rigid material and/or flexible material, but in exemplary reality Apply in example, material is biocompatibility.It will be appreciated by those skilled in the art that term " flexibility " used herein and " rigidity " It is intended to various configurations.In general, " flexibility " component has a certain degree of elasticity, for example, can bend without breaking Split, and " rigidity " component then lacks flexibility.In one exemplary embodiment, device or it is raw by least one at least partially Thing compatibility material is constituted, such as plastics, titanium, stainless steel etc..
It will be appreciated by those skilled in the art that present invention can apply to conventional endoscope operation and open operation apparatus, Can also be applied to robotic assisted surgery.
Apparatus as disclosed herein may be designed as, using once abandoning afterwards, being also designed to for being used for multiple times.But no matter It is which kind of situation, the device all can be at least using once exercising use by repairing again afterwards.Reparation may include device dismounting, it Specific part and the follow-up any combination for these steps such as re-assemblying are changed in rear cleaning.Specifically, detachably should Device, and any amount of specific component or part of device can be optionally changed or pulled down in any combination.Cleaning And/or after changing particular elements, can ressemble apparatus in repair shop or by medical surgery team personnel before surgical operation is close to, For subsequently using.It will be appreciated by those skilled in the art that can be dismantled using multiple technologies during repair the device, clean/more Change and re-assembly.The use of these technologies and the repair the device of gained are within the scope of the present invention.
Those skilled in the art will appreciate that more features of the invention and advantage according to the various embodiments described above.Therefore, originally Invention is not limited by the content for having specifically illustrated and describe, but is defined by the appended claims.That quotes from herein is all Publication and bibliography are all clearly incorporated by reference herein in its entirety.
1. a kind of organization bracket delivery system, including：
Delivering guider, the delivering guider has at least that inner chamber therethrough and the periphery from its distal end are stretched out Tooth, at least one tooth is configured to through organization bracket and engages bone, and organization bracket is protected relative to the bone Hold in fixed position, the delivering guider also includes at least one window of the neighbouring distal end, at least one window It is configured to allow for observing the part being arranged in the inner chamber of the far-end.
2. system according to claim 1, wherein at least one window is included in the delivering guider being formed Multiple otch.
3. system according to claim 1, wherein at least one window is included in the delivering guider being formed Transparent part.
4. system according to claim 1, also including bone preparation tool, the bone preparation tool be configured to through The inner chamber of the delivering guider, and prepare to connect the bone of organization bracket.
5. system according to claim 4, wherein the bone preparation tool includes the perforation with least one tip Instrument, at least one tip is configured to get at least one on the organization bracket fixed by least one tip Hole, and the bone entered below the organization bracket.
6. system according to claim 1, also including support instrument in place, the support instrument in place is configured to be pushed away Enter the inner chamber of the delivering guider, and will be in place by the organization bracket of an at least tooth fix in position.
7. system according to claim 6, wherein support instrument in place includes that fastener applies instrument, the fastener is applied Processing tool has fastener holding member, and the fastener holding member is located at the fastener and applies the distal end of instrument, and is configured to Keep at least one fastener and apply the fastener, pass through at least one organization bracket of tooth fix in position described in, It is fixed on the bone below the organization bracket with by the organization bracket.
8. system according to claim 1, also including delivering axle, the delivering axle has at least stretched out from its distal end Individual tip, at least one tip is configured to through organization bracket, and the delivering guider can be arranged on it is described On delivering axle so that at least one tooth is configured to engage and is arranged at least one tip of the delivering axle Organization bracket.
9. system according to claim 8, also including delivery cannula, the delivery cannula has the leakage for being connected to its distal end Bucket, the delivering axle can be slideably disposed to through the delivery cannula.
10. system according to claim 1, wherein the delivering guider includes registration mechanism, the registration mechanism quilt It is configured to that predetermined radial position will be arranged on relative to the delivering guider through the instrument of the delivering guider.
CN201510069563.0A 2009-03-27 2010-03-29 Organization bracket delivery system CN104688280B (en)
US12/412499 2009-03-27
CN201010145524.1A CN101953698B (en) 2009-03-27 2010-03-29 Methods and devices for delivering and affixing tissue scaffolds
CN201010145524.1A Division CN101953698B (en) 2009-03-27 2010-03-29 Methods and devices for delivering and affixing tissue scaffolds
CN104688280A CN104688280A (en) 2015-06-10
CN104688280B true CN104688280B (en) 2017-06-20
CN201510069563.0A CN104688280B (en) 2009-03-27 2010-03-29 Organization bracket delivery system
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BRPI1001384B1 (en) 2019-11-26