CN105407813A - Enteroatmospheric fistula treatment devices - Google Patents

Enteroatmospheric fistula treatment devices Download PDF

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Publication number
CN105407813A
CN105407813A CN201480042382.2A CN201480042382A CN105407813A CN 105407813 A CN105407813 A CN 105407813A CN 201480042382 A CN201480042382 A CN 201480042382A CN 105407813 A CN105407813 A CN 105407813A
Authority
CN
China
Prior art keywords
fistula
embedded type
anchoring piece
tissue
type device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201480042382.2A
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Chinese (zh)
Inventor
H·F·卡里森
A·马瓦尼
S·皮耶拉尔迪
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Curaseal Inc
Original Assignee
Curaseal Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Curaseal Inc filed Critical Curaseal Inc
Priority claimed from PCT/US2014/043261 external-priority patent/WO2014205269A2/en
Publication of CN105407813A publication Critical patent/CN105407813A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae

Abstract

An implantable device covers and seals an enteroatmospheric fistula or other short-tract opening in tissue and assists in healing the fistula. The implantable device may include a cap that is configured to be positioned on a first side of the tissue and to substantially cover a first opening of the short-tract fistula. The implantable device may also include an anchor member operably connected to the cap. The anchor member may be configured to be positioned on a second side of the tissue and to substantially cover a second opening of the short-tract fistula. Also, the implantable device may include a plug structure operably connected to the cap and the anchor member. The plug structure may be configured to fill the short-tract fistula.

Description

Intestinal air fistula therapy equipment
The cross reference of related application
This application claims the U.S. Provisional Patent Application No.61/837 being entitled as " EnteroatmosphericFistulaTreatmentDevicesandMethods (intestinal air fistula therapy equipment and method) " submitted on June 20th, 2013, the priority of 597.During above-mentioned patent application is all incorporated herein by reference in their entirety.
Technical field
Present invention relates in general to medical treatment device, relate more specifically to the therapy equipment for intestinal air fistula.
Background technology
Fistula is abnormal tissue-welding path between two surfaces of health or connection means.Such as, fistula between bodily cavity cave and organ or in cave, chamber or can generate between organ and the surface of health.Fistula path or tract comprise the hole being arranged in soft tissue, and this hole extends to closing end from the first fistula opening or leads to one or more second fistula opening.Fistula can generate due to wound, can be the result that infection or abscess are formed, or can on purpose generate in (such as tracheostoma road, stomach feeding tube road etc.).But, most of abnormal fistula can typically congenital generation, after the procedure occur, due to operation related complication occur or due to wound occur.Fistula can have tract or the path of epithelization, endothelialization or mucosa usually.
Fistula can almost formed between any two organs.Such as, fistula can occur in (such as intestinal fistula of skin, stomach fistula of skin, anal fistula etc.) between internal and skin, or between two internals (such as gastrointestinal fistula, colovesical fistula etc.).The perforated intestinal exposed by the abdominal wound opened or rectum are referred to as " intestinal air fistula ".
Some fistulas can oneself close, and may not cause personal great bodily injury, and some fistulas are life-threatening, and may cause death.Such as, the intestinal fistula of skin between intestinal and skin may cause intestinal contents to enter in abdominal part, and this may cause great medical problem.In addition, fistula is difficult to treatment usually.Such as, although negative pressure usually can be used to treat the abdominal wound of other type, when intestinal air fistula, intestinal juice may suck abdominal part from intestinal by negative pressure, and this can cause septicemia.Meanwhile, may be difficult to sew up or sew on closed intestinal fistula simply.Such as, tissue may major injury, and increase additional perforation may damaged tissue further to sew up closed tissue, hinder and heal.
The method for the treatment of fistula can be a surgical operation, and wherein fistula and affected organ part are removed.But, this surgical operation normally capital operation, and mortality rate may be high.In addition, the patient standing this surgical operation (such as intestinal fistula of skin) may have chronic inflammatory disease at affected areas adjacent, and may have the binding of stiff and highly fragile tissue, makes this process more complicated.Other therapeutic choice can comprise embedded type device, and it is designed to help by the closed fistula of health oneself.But some in these devices may cause disadvantageous immunoreation, fluid may be allowed to leak around device, may be ejected and leave or may move from its current location when patient moves.
The information that description background technology part comprises, comprise any list of references of quoting herein and to its any description done or discussion, only be included for the object of Technical Reference, and should not be considered to the theme of the scope of the invention that will limit defined in claim.
Summary of the invention
An example of the present invention can comprise a kind of short-track opening for blocking the such as short-track fistula in tissue and contribute to curing the embedded type device of this short-track opening.This embedded type device can comprise cap portion, and the first side that this cap cage structure becomes will be positioned in tissue covers first (such as near-end) opening of the fistulous tract in tissue substantially.This embedded type device can also comprise the anchoring piece that may be operably coupled to cap portion.The second side that anchoring piece can be configured to be positioned in tissue covers second (such as far-end) opening of fistulous tract substantially.Embedded type device can also comprise the plug structure be operatively coupled between cap portion and anchoring piece.This plug structure can be configured to be located or to be received in fistulous tract.Short-track fistula can comprise region and the conical region of the diameter with relative constancy.Device described herein can be configured to accommodate in this physiological structure.
Another example of the present invention can comprise a kind of method for the treatment of fistula or wound.The method can comprise to be inserted anchoring piece in the fistula (such as short-track fistula) in tissue.Then can operate (such as rotate and/or expand) anchoring piece, thus this anchoring piece covers first (such as far-end) opening of fistulous tract substantially.Then cap portion second (such as near-end) overthe openings (such as after anchoring piece is in place) at fistulous tract in place can be made.Then can be operably connected cap portion and anchoring piece, to form sealing above at least one in the first and second openings of fistulous tract.
Another example can comprise the embedded type device being used for the treatment of fistula (the short-track fistula such as in tissue).This device can comprise the first component, and the first component is configured to be positioned on the first side of fistula, covers the first opening of fistulous tract.This device can also comprise second component, and second component is configured to may be operably coupled to the first component and is positioned on the second side of tissue, to cover the second opening of fistulous tract.Plug structure can may be operably coupled to the first and second components, and can be configured to be received in fistula.
This summary of the invention is provided as introduces selectable concept in simplified form, hereafter further describes these concepts in a specific embodiment.This summary of the invention is not intended to key or the basic feature of determining theme required for protection, is also not intended to the scope for limiting theme required for protection.More substantial description with the feature of the present invention, details, practicality and the advantage that limit for claim shown in the drawings is provided in the text description hereafter for various embodiment of the present invention.
Below with reference to the accompanying drawings these and other aspect and embodiment are described in further detail.
Accompanying drawing explanation
Figure 1A is the front view of the people with intestinal air fistula (that is, by perforation intestinal that the wound opening on epidermal area is close).
Figure 1B is the amplification view of the fistula in intestinal.
Fig. 2 is the isometric view being in the embedded type device of extended position being configured to will insert in the intestinal fistula of Figure 1B.
Fig. 3 A is the sectional view of the embedded type device of the Fig. 2 be partly interposed in intestinal fistula.
Fig. 3 B is the sectional view of the embedded type device of the Fig. 2 being inserted through intestinal fistula.
Fig. 3 C is the sectional view of the embedded type device of Fig. 2 of Partial Blocking intestinal fistula.
Fig. 3 D inserts completely and blocks the sectional view of the embedded type device of Fig. 2 of intestinal fistula.
Fig. 3 E is the top plan view of the embedded type device of the Fig. 2 be inserted in intestinal fistula.
Fig. 4 A is the sectional view of the embedded type device of the Fig. 2 be inserted in fistula opening, wherein has the anchoring piece being in and inserting configuration.
Fig. 4 B is the sectional view of the embedded type device of the Fig. 2 be inserted in fistula opening, and wherein anchoring piece is in expanded configuration.
Fig. 5 is the isometric view of another example of the embedded type device being in the Fig. 2 shrinking or insert configuration.
Fig. 6 A is the sectional view of the embedded type device of Fig. 5 at fistula overthe openings in place before insertion.
Fig. 6 B is the sectional view of the embedded type device of the Fig. 5 be inserted in fistula, and wherein anchoring piece is in insertion configuration.
Fig. 6 C is the sectional view of the embedded type device of the Fig. 5 be inserted in fistula, and wherein anchoring piece is in expanded configuration.
Fig. 7 is the isometric view of another embodiment of implanted intestinal air fistula therapy equipment.
Fig. 8 A is the sectional view of the embedded type device of the Fig. 7 be inserted in fistula.
Fig. 8 B shows the amplification view of Fig. 8 A of the fixture of embedded type device.
Fig. 8 C is the top plan view of the embedded type device of the Fig. 7 be inserted in fistula.
Fig. 9 is the isometric view of another embodiment of implanted intestinal air fistula therapy equipment.
Figure 10 A is the sectional view of the embedded type device of the Fig. 9 be inserted in fistula.
Figure 10 B is the top plan view of the embedded type device of the Fig. 9 be inserted in fistula.
Figure 11 A is the isometric view of another embodiment of implanted intestinal air fistula therapy equipment.
Figure 11 B is the decomposition front section view of the embedded type device of Figure 11 A.
Figure 12 A is the sectional view of the embedded type device of Figure 11 A be inserted in fistula.
Figure 12 B is the top plan view of the embedded type device of Figure 11 A be inserted in fistula.
Figure 13 is the exploded view of another example of the embedded type device of Figure 11 A.
Detailed description of the invention
This document describes the embodiment of the embedded type device of other opening being used for the treatment of such as wound in intestinal air fistula, short-track fistula and tissue.In certain embodiments, this embedded type device blocks and covers fistula or wound opening, with Promotive union (in certain embodiments, not needing stitching thread or stitching).This embedded type device can insert in fistula or wound opening, to close or to seal fistula or wound opening, and can the material of tissue growth be promoted to make by one or more or comprise this material, to contribute to for good and all closing fistula or wound opening.Embedded type device may be used for dissimilar fistula, tissue openings or other wound of some.
Embedded type device can comprise cap portion and anchoring piece, via comprising tissue growth, this cap portion and anchoring piece can promote that the plug portion serve section of material (such as collagen protein) or supporting structure link together.The tissue growth that this configuration can allow tissue growth to arrive plug portion serve section or supporting structure promotes around material neutralization materials.In addition, together with cap portion can be pulled with anchoring piece, to promote material plug portion section by tissue growth or to carry out seal tissue opening by independent maintenance or fastening structure (such as stitching thread, Bioabsorbable hook and ring or both).Therefore, embedded type device can provide fistula to seal and framework for tissue ingrowth.
First component of device or cap portion can be configured to will be positioned on first or outer surface of damaged tissues, or against first (such as near-end) opening or above it of short-track fistula.Such as, cap portion can be made up of one or more impermeable biocompatibility and/or bioabsorbable material.Like this, cap portion can prevent liquid (such as intestinal juice) and other material from entering or leaving fistula opening, also substantially prevents the infringement to health and the autoimmune reaction from health simultaneously because this material may finally absorb by health.This is such as very important when intestinal fistula, and in this case, the impermeable cap portion of device can prevent intestinal material and liquid from entering abdominal cavity by fistula.Similarly, second component or anchoring piece can be configured to second (such as far-end) opening (opening in the interior surface of such as damaged tissues) at short-track fistula in place top, and such as can be made up of one or more impermeable biocompatibility and bioabsorbable material.Certainly, the material that can may alternatively or additionally use other suitable.Together with cap portion can be operatively coupled on anchoring piece, by the tissue holder around fistula betwixt.Cap portion and anchoring piece can be linked together by any suitable mode, include but not limited to plug portion serve section, stitching thread, bonding configuration, hook and ring fixture, collagen protein connector, via magnetive attraction or by other similar structure.
Anchoring piece can be configured to be inserted in fistula opening, is then expanded and is operated.This expansion and operation can substantially by anchoring piece fastened in place through the organizing on second or medial surface of insert of this opening.In a kind of example, anchoring piece can comprise a series of stacking sheet material with diameter that is identical or change, can folded or compression when this sheet material is in the first opening being inserted into fistula, then can be expanded or launch when leaving the second opening of fistula.
In multiple configuration, cap portion can be spaced from each other with anchoring piece on the relative side of fistula surrounding tissue, but substantially fastened in place.This can allow damaged tissues to grow together in the space between cap portion and the surface of anchoring piece, simultaneously closed or sealing fistula.In addition, cap portion, anchoring piece and/or separation or fastening structure can be Bioabsorbables, thus it can finally be absorbed in health.
Figure 1A is the front view of the people 100 of the intestinal 105 with perforation.The wound 102 opened in stomach wall 104 makes the fistula 106 in intestinal 105 expose in an atmosphere.Due to wound 102 additional in abdominal cavity 104, fistula 106 may be difficult to treatment.Figure 1B shows the enlarged drawing of the impaired intestinal tissue 112 of fistula 106.Fistula 106 can extend through one or more layers of tissue 112, and can have any one in the different size of some and shape.
Fig. 2 is the isometric view of the embedded type device 110 for closed whole fistula 106.Embedded type device 110 extends into the edge covering tissue 112 on the both sides of fistula 106, and blocks fistulous tract, thus is provided for the framework of tissue 112 growth, for good and all to close fistula 106.Although embedded type device 110 is depicted as the fistula 106 in closed intestinal 105, it may be used for the opening of any short length in closing tissue substantially, includes but not limited to short-track fistula, colon is torn, vascular puncture etc.
Embedded type device 110 is configured to will be inserted in the fistula 106 in tissue 112.Fig. 3 A-3D be respectively be partly interposed in intestinal fistula, be inserted through intestinal fistula, Partial Blocking intestinal fistula and insert completely and block the sectional view of the embedded type device of Fig. 2 of intestinal fistula.Fig. 3 E is the top plan view of the embedded type device of the Fig. 2 be inserted in intestinal fistula.As shown in the figure, embedded type device 110 can comprise cap portion 114, is operably connected or is attached to anchoring piece 116 and the plug structure 118 in cap portion 114.When anchoring piece 116 is in its expanding location (such as seeing Fig. 2), cap portion 114 can have the diameter less than anchoring piece 116.Cap portion 114 is configured to be inserted in first (such as near-end) surface 122 (Fig. 3 D) top of tissue 112, and partly enters in opening 106 above opening 106.
Cap portion 114 can be formed as the spherical extension of plug structure 118, covers an end of fistula 106.Spherical caps portion 114 can be configured with the diameter larger than the diameter of the opening of fistula 106, so that anti-fluid and other material enter or leave fistula 106 substantially.Cap portion 114 can not the material silicones of osmotic fluid (such as can not) of osmotic fluid can be formed by one or more, and anti-fluid and other material enter or leave fistula 106 around cap portion 114 or through cap portion 114 thus.In some cases, cap portion 114 can be Bioabsorbable (such as, cap portion 114 can be formed by one or more bioabsorbable polymers), thus cap portion 114 can finally by the body absorption of people 100.Cap portion 114 can also be other shape or size (such as seeing Fig. 6 A).
Cap portion 114 can be spherical, and can operationally to downward-extension, to form plug structure 118.With reference to figure 2 and 3D, plug structure 118 can be from the lower surface in cap portion 114 downwards (or distally) extend and may be operably coupled to the axle of anchoring piece 116.Cap portion 114 is operationally connected to anchoring piece 116 by plug structure 118, and makes both be spaced from each other.This advantageously can prevent cap portion 114 and anchoring piece 116 pinching or force tissue 112 to leave from its marginal position by alternate manner.By the tissue growth of such as collagen protein, plug structure 118 can promote that material is made.Therefore, plug structure 118 can provide a class framework or support, and tissue can grow through this framework or support, to fill fistula 106.The material that can may alternatively or additionally use other suitable.
As shown in Figure 3A, anchoring piece 116 can be flexible substantially, thus it can insert in fistula, and then can to external expansion (as shown in Figure 3 D).With reference to figure 3B, in one embodiment, embedded type device 110 can be inserted through fistula, is first anchoring piece 116, until whole device 110 is positioned in the opposite side of tissue.After embedded type device 110 is inserted into, surgeon can pull the stay cord 113 that may be operably coupled to cap portion 114.With reference now to Fig. 3 C, along with making cap portion 114 upwards stressed, cap portion 114 and plug structure 118 can insert in fistula again.Anchoring piece 116 does not insert again, but forms sealing on the bottom opening of fistula.With reference now to Fig. 3 D, once cap portion 114 has arrived another opening part of fistula, then it can have been expanded and form connector or sealing with the opposite side at fistula.Fig. 3 E is the top plan view of the embedded type device 110 be inserted in fistula 106.
With reference now to Fig. 4 A and 4B, anchoring piece 116 can comprise a series of sheet material 124,126,128,130 with smaller szie in succession, this sheet material can be compressed or is out of shape to fit through fistula, then can expand or reformation shape (such as becoming original sheet form).Before embedded type device 110 inserts in fistula 106, sheet material 124,126,128,130 can shrink or fold.At sheet material 124,126,128,130 by fistula and after entering in abdominal cavity, plug structure 118 is in place in fistula 106, sheet material 124,126,128,130 can to external expansion.Thus, the sheet material 124,126,128,130 of anchoring piece 116 can cover the second end of fistula 106, and can be wider than opening 106, but can still can in insertion opening 106.Anchoring piece 116 covers the opening of the fistula 106 be positioned on tissue 112 inwall, and for being anchored in fistula 106 by embedded type device 110, preventing embedded type device 110 from easily being moved or being forced to leave fistula 106.Sheet material 124,126,128,130 can comprise any suitable material or multiple material (such as collagen protein), and can comprise identical or different material.
Fig. 4 A is the cross section of embedded type device 110 before anchoring piece 116 is expanded be inserted in fistula 106, and Fig. 4 B is the sectional view of embedded type device 110 after anchoring piece 116 is expanded be inserted in fistula 106.Sheet material 124,126,128,130 can be out of shape, with around bending is folding or bending each other, to be inserted in fistula 106.Such as, the interior sheet 130 of minor diameter can be bent downwardly from the central connection point with adjacent sheet 128 or fold.The middle sheet material 128 with the diameter larger than interior sheet 130 can be adjacent to interior sheet 130 and substantially above interior sheet 130 and around fold, the second middle sheet material 126 with the diameter larger than the first middle sheet material 128 can be out of shape similarly around the first middle sheet material 128.Above middle sheet material 126 and therefore there is larger-diameter outer sheet 124 can fold in middle and interior sheet 128,130.In certain embodiments, sheet material 124,126,128,130 can be connected in the midpoint of each sheet material 124,126,128,130.
With reference to figure 4B, after sheet material 124,126,128,130 is inserted through fistula 106 and enters in abdominal cavity, sheet material 124,126,128,130 can to external expansion.Outer sheet 124 can one-tenth in place with tissue 112 second surface 120 adjacent, second middle sheet material 126 can one-tenth in place adjacent with outer sheet 124, first middle sheet material 128 can one-tenth in place adjacent with the second middle sheet material 126, interior sheet 130 can one-tenth in place adjacent with the first middle sheet material 128.In this configuration, sheet material 124,126,128,130 forms stair-stepping inverted pyramid or frustum structure.Outer sheet 124 is configured to expand above the inside opening in tissue 112, thus the cap formed above fistula 106 or sealing.Middle sheet material 126,128 and interior sheet 130 provide self-supporting structure, to ensure that the span of maximum gauge sheet material 124 covers and seals the opening of fistula 106.Each sheet material 124,126,128,130 can be made up of slightly different material prescription, to increase the stiffness from maximum gauge sheet material 124 to minimum diameter sheet material 130.In this way, minimum sheet material can support the span of maximum sheet material 124 better.Selectively, based on forming the material of sheet material 124,126,128,130, the inherent structure of material can reduce along with size and wild phase to stiffness.
Sheet material 124,126,128,130 can have elastic force and flexibility, allows sheet material 124,126,128,130 folding or be deformed on position, and then when exposing from the second end of fistula 106 to external expansion or flick.This can allow anchoring piece 116 to be inserted through fistula 106, and further damaging tissue 112 or increase diameter or the size of fistula 106 substantially.
Sheet material 124,126,128,130 can be any size or shape substantially, and can present any suitable quantity, as long as they can shrink with through fistula 106.Such as, in certain embodiments, anchoring piece 116 can by be similar to umbrella, can be formed by abducent single supporting sheet on stay cord.Also other suitable anchoring piece can be used to construct.
With reference now to Fig. 3 A and 4B, when embedded type device 110 in place in fistula 106 and anchoring piece 116 is expanded time, embedded type device 110 can substantially cover fistula 106 on two of tissue 112 surface.Cap portion 114 is configured to first (such as near-end) overthe openings wanting the fistula 106 in the first surface 122 of tissue 112 in place.Plug structure 118 inserts in fistula 106, and can be configured with approximately identical with fistula 106 diameter, fills fistula 106 thus.When expanded, anchoring piece 116 covers second (such as far-end) opening of fistula 106, and one-tenth in place is adjacent with the second surface 120 of tissue 112.Cap portion 114 and anchoring piece 116 can be spaced apart from each other the distance of the thickness at least equaling tissue 112.Such as, as shown in Figure 3A, plug structure 118 can have approximately identical with the thickness of tissue 112 length, and therefore can provide suitable spacing distance between cap portion 114 and anchoring piece 116.
It should be noted that anchoring piece 116 and cap portion 114 can comprise one or more impermeable materials.In this way, substantially anti-fluid (such as intestinal juice), refuse (such as Excreta) and other material the first surface 122 of tissue 112 can be marched to from the second surface 120 of tissue 112 via fistula 106.Therefore, embedded type device 110 can contribute to preventing the medical complications because fluid, refuse etc. cause through fistula leaks.
Meanwhile, the tissue growth that can comprise one or more such as collagen protein due to supporting structure 118 promotes material, and therefore embedded type device 110 can provide tissue growth framework.Can promote to grow in the fistula 106 of tissue 112 through the framework of plug structure 118 cap portion 114 and anchoring piece 116, to fill fistula 106 and to cure tissue injury thus.In addition, substantially clamp due to cap portion 114 and anchoring piece 116 or encase tissue 112, therefore can promote that the horizontal organization of the diameter of the end of crossing fistula 106 grows.
Embedded type device 110 can comprise multiple different embodiment.Such as, Fig. 5 is the isometric view of another configuration of embedded type device 210, and this embedded type device 210 can be substantially similar with the embedded type device 110 shown in Fig. 2.But embedded type device 210 can comprise variform cap portion 214.In this embodiment, cap portion 214 is plane or plate-like substantially, instead of spherical.Other embodiment of embedded type device can comprise and has other difform cap portion.
Fig. 6 A illustrates that embedded type device 210, Fig. 6 B before inserting in fistula 106 illustrates and is inserting the embedded type device 210 after embedded type device 210, Fig. 6 C during fistula 106 illustrates in insertion fistula 106.As shown in Figure 6A, before insertion, sheet material 124,126,128,130 can be out of shape, with through fistula 106, as above about illustrated by Fig. 4 A.As can be seen, sheet material 124,126,128,130 can fold to bend around each other downwards.As shown in Figure 6B, when plug structure 118 inserts in fistula 106, sheet material 124,126,128 can arrive the second side of fistula 106 along with it and start expansion.With reference now to Fig. 6 C, once plug structure 118 inserts in fistula 106 completely, then sheet material 124,126,128,130 can be expanded completely, to form anchoring piece 116.Anchoring piece 116 covers the second end of fistula 106.
Fig. 7 is the isometric view of another embodiment of embedded type device 310.Embedded type device 310 can be substantially similar with embedded type device 110, because it can comprise cap portion 314 and anchoring piece 316.But embedded type device 310 can not comprise plug structure.On the contrary, anchoring piece 316 operationally can be connected via fixture 318 with cap portion 314.In addition, anchoring piece 316 can be integral piece, instead of is formed by multiple sheet material as in previous embodiments.Certainly, other suitable configuration of anchoring piece also can use together with fixture.
Fig. 8 A is the sectional view of the embedded type device 310 be inserted in fistula 106, and Fig. 8 B is the enlarged drawing of a part of Fig. 8 A, and Fig. 8 C is the top plan view of the embedded type device 310 be inserted in fistula 106.Anchoring piece 316 can be the component of plate-like substantially, and this component has the diameter larger than the opening of fistula 106.In certain embodiments, anchoring piece 316 can be out of shape and be inserted through fistula 106, and wherein, once anchoring piece launches in the recess that the second side 120 with tissue 112 is adjacent, then surgeon can operate this anchoring piece.Such as, anchoring piece 316 can be manipulated into for being adjacent to arrange with the second side 120 of tissue 112, and can substantially cover the opening of fistula 106 by one-tenth in place.In such an embodiment, anchoring piece 316 can be substantially similar with cap portion 314, and can be formed by impermeable material, to seal fistula 106.
Fig. 8 B is the enlarged drawing being inserted in the embedded type device 310 in fistula 106 as shown in Figure 8 A.Once the anchoring piece 316 opening becoming to cover fistula 106 in place, then cap portion 314 and anchoring piece 316 can tighten together.Fixture 318 can may be operably coupled to each cap portion 314 and anchoring piece 316.In certain embodiments, the fixture 318 being connected to cap portion 314 can also be connected to the part 318 that is relatively fixed, and this part that is relatively fixed transfers to be connected to again anchoring piece 316.In certain embodiments, fixture 318 can be inserted in the tissue 112 around fistula 106.
In one exemplary embodiment, with reference to figure 8B, at least some in fixture 318 can comprise hook fixture 321 and ring fixture 322.Hook fixture 321 can be configured to engage with ring fixture 322 or be connected.In one example, the lower surface in cap portion 314 can be formed together with hook fixture 321, and the top surface of anchoring piece 316 can be formed together with ring fixture 322.Hook fixture 321 can be pressed through tissue 112 and leave and enter in the cave, chamber on the opposite side of fistula 106, to engage with ring fixture 322.Also other embodiment and the combination of fixture can be used.
Fixture 321,322 is used as hook and loop systems, to be tightened together in cap portion 314 and anchoring piece 316, prevents cap portion 314 and anchoring piece 316 from mutually departing from thus.In certain embodiments, hook fixture 321 can relative stiffness, thus it can penetrate tissue 112, and is used as cap portion 314 and the isolated distance piece of anchoring piece 316, to avoid pinching tissue 112.In certain embodiments, fixture 318 can be made up of one or more bioabsorbable material, thus its propelling along with the time can finally be absorbed in tissue 112.
As shown in Figure 8 A, upon insertion, tissue 112 is clipped between cap portion 314 and anchoring piece 316 by embedded type device 310.Collagen protein connector 317 can be disposed in the fistula 106 between cap portion 314 and anchoring piece 316, to promote to be organized in the growth in fistula 106.The tissue 112 that this configuration can contribute to ensureing to break heals more rapidly.In addition, cap portion 314 one-tenth in place can cover fistula 106, thus contributes to anti-fluid and other material enters or leave fistula 106.
In another embodiment, with reference now to Fig. 9, embedded type device 410 can use captivation (such as magnetive attraction) make cap portion 414 and anchoring piece 416 reliably in place.Figure 10 A is the sectional view of the embedded type device 410 be inserted in fistula 106, and Figure 10 B is the top plan view of embedded type device 410.In this embodiment, cap portion 414 and anchoring piece 416 can have substantially the same size.
In this embodiment of embedded type device 410, both cap portion 414 and anchoring piece 416 all can comprise the magnetic material of one or more types be dispersed in its whole body, such as ferromagnetic material.The non-limiting example of ferromagnetic material comprises ferrum, iron oxides, magnetic iron ore and ferrofluid.Due to magnetic material, cap portion 414 and anchoring piece 416 can cross tissue 112 when aliging rightly and attract each other.The function of this polarity can be similar with previously described fixture 320, because magnetive attraction makes cap portion 414 substantially in place above anchoring piece 416.
Anchoring piece 414 can be out of shape, and to insert in fistula 106, is then operated in abdominal cavity, to recover the disc shaped of its normal plane and to cover opening.Because anchoring piece 416 can comprise the magnetics be dispersed in its whole body, therefore after anchoring piece 416 has been inserted through fistula 106, surgeon can use Magnetic tools to operate anchoring piece 416.Anchoring piece 416 can be aligned to and make it substantially cover fistula 106 by positioning magnet.
Continue with reference to figure 9 and 10A, embedded type device 410 additionally can comprise the distance piece 418 be positioned between cap portion 414 and anchoring piece 416.Distance piece 418 can contribute to the direct connection prevented between cap portion 414 and anchoring piece 416, and this connection may pinching tissue 112 or force tissue 112 to leave between cap portion 414 and anchoring piece 416.In some cases, if the magnetic attraction between cap portion 414 and anchoring piece 416 causes these two parts As time goes on compress the tissue 112 of fistula 106 perimeter and make it downright bad, make fistula 106 become large instead of Promotive union thus, then can use distance piece 418.In certain embodiments, distance piece 418 can have substantially equal with the thickness of tissue 112 height.This can allow cap portion 414 and anchoring piece 416 spaced apart enough far away to avoid applying too many pressure on tissue 112, but be enough close together to provide good sealing relative to tissue 112.
Distance piece 418 can have any suitable configuration, in certain embodiments, can be inserted in substantially columniform axle in the tissue 112 between cap portion 414 and anchoring piece 416 or bar.Such as, distance piece 418 can comprise one or more bioabsorbable material (material of such as relative stiffness).The non-limiting example of bioabsorbable material that may be suitable comprises bioabsorbable polymers, such as Poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly-(dextrorotation lactide/glycolides) copolymer (PDLA) and polycaprolactone (PCL).In one embodiment, distance piece 418 can be formed and extend from this surface on the surface in cap portion 414.
In operation, anchoring piece 416 can to insert in fistula 106 and to operate in abdominal cavity, with the edge of coverage hole and contiguous tissue 112.Once anchoring piece 416 is in place, then distance piece 418 can be inserted in tissue 112 and to may be operably coupled to anchoring piece 416.May alternatively or additionally, distance piece 418 can insert in fistula 106, to be connected to anchoring piece 416 without tissue 112.Then cap portion 414 can be disposed on the top of first surface of tissue 112, is located substantially on the top of fistula 106 and anchoring piece 416.Selectively, distance piece 418 can be formed and extend from this surface on the surface in cap portion 414.Cap portion 414 can be arranged on tissue 112, and distance piece 418 can be pushed into through tissue 112.In some cases, some distance pieces 418 can be pushed into through tissue 112, and other distance piece 418 can be pushed into through fistula 106 and not enter tissue 112.In certain embodiments, whole distance piece 418 can be pushed into through fistula 106 and not enter tissue 112.The captivation of cap portion 414 and anchoring piece 416 may be used for making to be held in place above the first and second ends of its each comfortable fistula 106.
Figure 11 A and 11B is the exploded isometric view Sum decomposition front view of another embodiment of embedded type device 510 respectively.In this embodiment, embedded type device 510 can comprise cap portion 514, and cap portion 514 has bar handle 527, and bar handle 527 has head 529 at first end.Embedded type device 510 can also comprise anchoring piece 516, and anchoring piece 516 defines receiving compartment cave 525, and receiving compartment cave 525 is configured for the head 529 receiving cap portion 514.Figure 12 A is the sectional view of the embedded type device 510 be inserted in fistula 106, and Figure 12 B is the top plan view of the embedded type device 510 be inserted in fistula 106.The fastening configuration that cap portion 514 and anchoring piece 516 are configured to fasten or other is suitable tightens together.
Cap portion 514 can have the top section of mushroom-shaped substantially, this top section in middle part to downward-extension to form bar handle 527.In other embodiments, bar handle in cap portion can delocalization at center, maybe can use multiple bar handle.Bar handle 527 can be similar with the plug structure 118 shown in Fig. 2 A, because bar handle 527 is configured to will be inserted in fistula 106.The first end being inserted in the bar handle 527 in fistula 106 can stretch out to form spherical head 529.Bar handle 527 and head 529 tissue growth of each freedom such as collagen protein can promote that material is formed.This can allow tissue 112 to grow around with through bar handle 527 and head 529, to fill fistula 106.
The shape of anchoring piece 516 can be specified to substantially identical with cap portion 514.As mentioned above, anchoring piece 516 can be defined for the receiving compartment cave 525 of the head 529 receiving cap portion 514.Be positioned at by head 529 in receiving compartment cave 525 is make cap portion 514 may be operably coupled to anchoring piece 516.Receiving compartment cave 525 can be substantially identical with the size of head 529, and can receive head 529 in the mode be fastened and connected, thus cap portion 514 is fastened to anchoring piece 516.
In certain embodiments, cap portion 514 and anchoring piece 516 can comprise multiple bar handle and receiving compartment cave (such as, for reliably connecting large diameter embedded type device 510, to cover and to fill larger-diameter fistula).Such as, Figure 13 shows the cap portion 514 with three the bar handles 527 extended from lower surface and the anchoring piece 516 comprising three receiving compartment caves 525 for receiving each head 529.Meanwhile, although show rounded nose and cave, chamber configuration, the bonding structure of other form is also possible, and being fastened and connected shown in Figure 11 A and 13 is only a kind of exemplary embodiment.
In operation, anchoring piece 516 can be out of shape (such as fold or roll) and insert in fistula 106.Then anchoring piece 516 can operate in abdominal cavity, thus launches or sprawl and move in place.Then, operator can make cap portion 514 align with fistula 106, thus bar handle 527 and head 529 can insert in fistula 106.Then head 529 can be inserted through the second surface 120 of tissue 112, and is received within receiving compartment cave 525, thus head 529 is fixed in cave, chamber 525.In some cases, anchoring piece can comprise drawing piece, and this drawing piece may be used for keeping anchoring piece in place when downward promotion cap portion.Once cap portion 514 and anchoring piece engage, then 112 are organized can be substantially sandwiched between them.The length of bar handle 527 can provide suitable complementary range between cap portion 514 and anchoring piece 516, thus tissue 112 is not substantially compressed and makes a concession.
Description above has a wide range of applications.Such as, although the embodiment disclosed herein may pay close attention to closed intestinal air fistula or other short-track fistula, the idea disclosed herein can be applied to wound and the tissue openings of other type closed equally.Similarly, although may discuss fistula and wound about the mankind, the device disclosed herein and technology can be applied to other animal equally.Therefore, the discussion for any embodiment is only intended to be exemplary, and is not intended to imply the restriction of scope of the present invention (comprising claim) by these examples.
All orientation term (such as near-end, far-end, top, bottom, upwards, downwards, left side, right side, transverse direction, longitudinal direction, front, below, top, bottom, above, below, vertically, level, radial direction, axis, clockwise and counterclockwise) be only object for identifying, to help reader understanding the application, and do not produce restriction, particularly about position, direction or the use for invention.Connect term (be such as attached, connect, connect and engage) should broadly explain, and unless indicated otherwise, otherwise the relative movement between the intermediate member that can be included between many elements and these elements.Like this, connect term and may not refer to that two elements directly connect and mutually in fixed relationship.Exemplary accompanying drawing is only for illustrated object, and the size reflected in accompanying drawing, position, order and relative size can change.
Description above, example and data provide the description for the structure of exemplary embodiment of the present invention defined in claim and the complete of use.Although above by characteristic to a certain degree or the various embodiments describing claimed invention with reference to one or more independent embodiment; but when not deviating from claimed the spirit or scope of the present invention, those skilled in the art can carry out multiple change to disclosed embodiment.Therefore it is contemplated that other embodiment.What description above comprised should be construed as being only the explanation to specific embodiment with the full content shown in accompanying drawing, instead of restrictive.When not deviating from the fundamental of the present invention defined in claim hereafter, can change details or structure.

Claims (16)

1. be configured for being inserted into the embedded type device in the short-track fistula in tissue, this embedded type device comprises:
The first side being configured to be positioned in tissue covers the cap portion of the first opening of short-track fistula substantially;
May be operably coupled to cap portion and the second side being configured to be positioned in tissue covers the anchoring piece of the second opening of short-track fistula substantially; With
To be operatively coupled between cap portion and anchoring piece and to be configured to be positioned in the plug structure in short-track fistula.
2. embedded type device according to claim 1, wherein, the first opening is the proximal openings of short-track fistula.
3. embedded type device according to claim 2, wherein, the second opening is the distal openings of short-track fistula.
4. embedded type device according to claim 1, wherein, plug structure comprises collagen protein.
5. embedded type device according to claim 1, also comprises:
May be operably coupled to the hook fixture on the surface in cap portion; With
May be operably coupled to the ring fixture on the surface of anchoring piece,
Wherein, hook fixture is configured to through tissue and will to be inserted in ring fixture.
6. embedded type device according to claim 1, wherein:
Cap portion also comprises the first magnetic material; With
Anchoring piece comprises the second magnetic material being substantially attracted to the first magnetic material.
7. embedded type device according to claim 1, wherein, anchoring piece comprises the first sheet material, and this first sheet material has the first configuration and second expanded configuration with a size that allow through short-track fistula, and the size that this second expanded configuration has is larger than the diameter of short-track fistula.
8. embedded type device according to claim 7, wherein, anchoring piece also comprises the second sheet material, be connected to the first sheet material this second sheet being operable, and there is the 3rd configuration and there is the 4th configuration of expansion of a size, the size that the 4th configuration of this expansion has than short-track fistula diameter greatly but less than the size of the first sheet material.
9. embedded type device according to claim 1, wherein, plug structure is connected directly to cap portion, and is connected to anchoring piece via being fastened and connected.
10. embedded type device according to claim 9, wherein, plug structure also comprises:
From the bar handle that the lower surface in cap portion extends; With
From the head that the bottom end of bar handle extends.
11. embedded type devices according to claim 10, wherein, anchoring piece also comprises the cave, chamber being at least partially configured for receiving head.
12. 1 kinds of embedded type devices, comprising:
To cover the first component of the first opening of the short-track fistula in tissue on the first side being configured to be positioned in tissue;
Be configured to may be operably coupled to the first component and to cover the second component of the second opening of short-track fistula on second side that will be positioned in tissue; With
May be operably coupled to the first component and second component and be configured to be received within the plug structure in short-track fistula.
13. embedded type devices according to claim 12, wherein, second component is deformed into the first configuration before being configured in the short-track fistula of insertion, and is extended to the second configuration after inserting in short-track fistula.
14. embedded type devices according to claim 13, wherein, second component comprises the first sheet material, and this first sheet material is configured to be deformed into the first configuration, and is extended to the second configuration to have the size larger than the diameter of short-track fistula.
15. embedded type devices according to claim 12, wherein, plug structure is connected directly to the first component, and is connected to second component via being fastened and connected.
16. embedded type devices according to claim 12, wherein, plug structure is tissue growth frame material.
CN201480042382.2A 2013-06-20 2014-06-19 Enteroatmospheric fistula treatment devices Pending CN105407813A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361837597P 2013-06-20 2013-06-20
US61/837,597 2013-06-20
PCT/US2014/043261 WO2014205269A2 (en) 2013-06-20 2014-06-19 Enteroatmospheric fistula treatment devices

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070135842A1 (en) * 1991-10-22 2007-06-14 Kensey Nash Corporation Sealing device
CN101889884A (en) * 2010-06-13 2010-11-24 西安交通大学 Magnetic device for repairing first-stage intestinal fistula
CN201691972U (en) * 2009-09-25 2011-01-05 王峰 Cavity fistula aperture stopper
CN102046095A (en) * 2008-05-29 2011-05-04 库克生物科技公司 Devices and methods for treating rectovaginal and other fistulae

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070135842A1 (en) * 1991-10-22 2007-06-14 Kensey Nash Corporation Sealing device
CN102046095A (en) * 2008-05-29 2011-05-04 库克生物科技公司 Devices and methods for treating rectovaginal and other fistulae
CN201691972U (en) * 2009-09-25 2011-01-05 王峰 Cavity fistula aperture stopper
CN101889884A (en) * 2010-06-13 2010-11-24 西安交通大学 Magnetic device for repairing first-stage intestinal fistula

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Application publication date: 20160316