CA2141873A1 - Stent construction and placement method - Google Patents
Stent construction and placement methodInfo
- Publication number
- CA2141873A1 CA2141873A1 CA002141873A CA2141873A CA2141873A1 CA 2141873 A1 CA2141873 A1 CA 2141873A1 CA 002141873 A CA002141873 A CA 002141873A CA 2141873 A CA2141873 A CA 2141873A CA 2141873 A1 CA2141873 A1 CA 2141873A1
- Authority
- CA
- Canada
- Prior art keywords
- roll
- core
- stent
- sheet
- condition
- 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.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2/9662—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the middle portion of the stent or stent-graft is released first
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
Abstract
A stent (10) for reinforcing a damaged wall in a body passage such as a vascular passage. The stent (10) takes the form of a sheet (11) of metal foil wound tightly around a spool (12) in a multiple layer roll (13) and held in a contracted state by a sheath (20) sleeved around the roll (13). The spool (11) is inserted into the body passage until the stent (10) is adjacent to the area of the damaged wall. The spool (11) and stent (10) are then advanced while the sheath (20) is held stationary. This pushes the stent (10) out the end of the sheath (20) and releases the stent (10) such that the roll (13) unwinds and expands against the damaged vessel wall.
Description
WOg4/03128 PCT/US93/06597 STENT CONST~C~ON ~ND P~A~EME~ MET~OD
. Field of the ~n~ention This invention relates in general to the rield or medical implants and more particularly to a s.ent which ~s constr~cted in an improved manner for simple and ef'ecti~e placement in a body - passage to reLnforce a damaged area.
Bac~round of the Inventi~
Tubular prostheses commonlv known as stents have been used ts reinrorce and strenalhen dama~ed ~lood vessels and other body passages. For example, .he blood ~essels can collapse, - dilate, become partially occL~ded or otherwise damaged by disease or other causes. The presence of an aneurysm~or stricture in the blGod vessel often requires implzmtation of a stent to strengthen ;~ the vasc~lar wall in the area of the damage. Other passages in the ody can also sometimes benefit from stent implantation, including .
the esophagus, the trachea, the gastro intestinal tract, the bile duct, _he ureter and the urethra.
The benefits of self-expanding stents have been recognized. A self-expanding stent is held in a contracted state until it has been positioned properly, typically with t~e aid of an instrument such as a catheter. After the stent has been placed properly in the damaged blood vessel, it is allowed to expand against the damaged vessel wall in order to reinforce the damaged ' - area. Examples of self-expanding stents are disclosed in U.S.
Patent Nos. 5,026,377 and 5,078,720 to Burton et al., U~S. Patent :
,.
SUBSTITUTE SHEET
W094tO3128 PCT/US93/06S97 ~o. ~,019,085 to Hillstead, -J.S. Patent ~o. ~,969,~58 to Wiktor, and U.S. Patent ~o. ~,041,126 to Gianturco. The ~ic~tcr ~nd Gianturco stents are in the form of coiled or looped wires that are unable to conlact the entirety of the weakened vessel wall. The ~;
same is true of the Hillstead stent ~hich takes the form of a multiple loop wire structure. The st nts disclosed in _he ~-~o ~-Burton patents are braided structures that are likewise incapable of contacting the enti~ety of the damaqed vessel wall. ~ll of the -~stents and particularly their placement means are com~licated to construc-, ~nd the stents are di.f~cult t~ place orecisely ~n the damaqed ~essel.
Summar~ of_the In~ention The present invention is directed to an improved stent whIch is particularly characterized by a stronger construction, the a~ility to provide a solid and continuous wall that lines the ; entirety of the damaged part of passage wall in which t is implanted, and by ease and accuracy of placement. In accordance with the invention, a stent is provided in the form of a flexible metal sheet which i5 closely wound around a spool in a spinal roll.
- A sheath initially surrounds the roll in order to retain it in a contracted state. The spool, stent and sheath can be inserted together into the body with the spool following a guide wire until it is located adjacent to the damaged area. Then, the sheath is , held stationary while the spool is pushed out the end of the --! sheath, with a flange on the spool making certain that the tightly coiled roll remains on the spool. Once the spool has cleared the ;, , i ;
,~
:i SUBSTITUTE SHEET
~ WO94/03128 2 1 4 1 ~ 7 3 PCT/US93/06597 I sheath, the roll is released and allowed to expand against the damaged ~all of the vPssel. The sheath and spool c n then be 3 - withdrawn, lea~ing tAe stent in place.
An alternative embodiment of the invention elimina~es the ` sheath and instead holds the stent in its retracted state by means -j of a pair of control cords which are connected by slip knots to -, flanges on the spool located adjacent to the opposite ends of the stent. When the stent has been properly positioned, the cords can be pulled to release the slip knots and allow the stent to expand - against the vessel wall. _a both embodimenls, multiple s.en~s can , be carried on the same s~ocl ,f it is necessary tO s~ren~then the vessel in more than one area.
Because the stent takes the form of a continuous sheet, the stent essentially contacts the entirety of the damaged vessel wall area, rather than simply reinforcing the damaged area as is t~e case with looped or coiled wires or braided netting type - structures. In addition, the stent preferably has multiple l~yers ., that bear against one another whem the stent is in its expanded condition. This further enhances the strength of the stent and provides multiple layers that are held against one another by friction resulting from the tendency for the stent to expand under the influence of internal spring force.
The method by which the stent is placed in the proper position and allowed to expand against the vessel wall is improved in a num~er of respects compared to what has been proposed in the past. The placement method is simple and accurate and does not ,',',.'' :' SUBSTITUTE SHEET
W094~03128 PCT/US93/06597 ~ 4.~ ~ 3 involve complexities such as the need to inflate a balloon c-~theter ~ or other mechanism.
- Description of the Drawin~s .1 In t~e accompanying drawings which form a part of the specification and are to be read in conjunction therewith and in ; which like reference numerals are used to indicate liXe parts in i the various views: -Fig. 1 is a fragmentary perspecti~e view of a s.ent and Dlacement system for the s~ent, all constructed ac~ording to a preferred em~odiment ~f t.~e ~resent invention, ~ith the stent in i~s retracted condition and part of '.~e sheath shown in section for purposes of illustration;
Fig. 2 is a fragmentary sectional view illustrating the stent being applied to a stricture in a blood vessel, with the broken lines depicting the spool and stent pushed out the end of ~ the sheath;
-- Fig. 3 is a fragmentary sectional view similar to Fig. 2, but showing the stent expanded against the damaged vessal wall prior to withdrawal of the sheath and spool;
Fig. 4 is a fragmentary sectional view showing an alternative embodiment of the invention in which the spool is constructed to carry multiple stents and to apply them to multiple damaged areas of a blood vessel;
Fig. 5 is a fragmentary sectional view of a stent arrangement constructed according to an alternative embodiment of the invention, with the stent in its retracted condition and .,.. ,., :
WO94/03128 PCT/~S93/06597 2 ~ 7 3 j posi~ioned properly f~r application to a dama~ed str~ure in a j blood vessei; and ~ Fig. 5 is a fraqmentary s~cti~al ~iew similar _a Fig. 5, 3 but showing the stent released and expanded against the aamaged ¦ vesse~ wall pri~r to withdrawal of the spool.
Detailed Description of t~e_Invention Referring now t~ the drawings in more detail and initially to Fig. l in particular, numeral 10 generally designates a stent which ~s constructed in ac~ordance with 2 ?referred embodiment cr 'he present inven~ion. ~he stent 10 takes ~he form of an initially flat metal sheel .Jhic~ is wound tightly around a core which is in the form of a tu~ular spool 12. The stent 10 is ~ preferably constructed of a stainless steel foil which is ;;~ commercially available under the trade designation PH15-7, Condition C~900. The thic~ness of the sheet ll is preferably about .0005 inch. When the sheet ll is coiled around the spool 12, it is in the shape of a spiral roll 13, and its outside diameter may be approximately 1.5 millimeter. The sheet 11 is long enou~h that there are approximately six or seven !ayers of the sheet which overlap one another when the roll 13 is in the contracted position shown in Figs. 1 and 2.
The sheet ll produces an innerent spring force which tends to expand the sheet from the retracted condition of the roll 13. ~y way of example, it is contemplated that the sheet will ~, initlally be rolled to a diameter of approximately S millimeters and then heat treated in that condition in order to relax the ~ `'`' ,..
, ~ SUBSTITUTE SHEET ::
WO94/03128 PCT/US93/06~97 7,3 internal stresses that are i~duced ~ windir.g .he shee~ ~o 2 ~artially contrac~ed condition. Followin~ the hea~ treatment, the ~aterial can be rolled into the tighter oll 13 (approximately 1.5 ~illimeter in diameter), and the ~oll will have fewer internal stresses than if it were initi~lly ~ound into the tight 1.5 ~illimeter cylinder. The internal spring force of the roll 13 will tend to cause it to unwind to an expanded condition in ~hich its diameter i5 approximately 5 millimeters (the diameter at -~hich the heat ~reatment takes place).
The sheet 11 is wound ~ightli ~n _he s~ool 12 near one end of the spool, and one end of the roll 13 butts a~ainst a flange 14 which is formed on the spool 12 at ~ location spaced rrom t~e end of the spool. The flange 14 projects radially from the spool 12 and has a diameter approximately equal to the diameter of the stent 10 in its ful1y contracted condition. The flange 14 is spaced from the end of the spool a distance greater than the axial length of the stent 10. The spool 12 is provided with a central axial passaqe 16 which receives a quide wire 13. As will be explained more fully, the spool 12 can be moved along the ~uide wire 18 in order to properly position the stent 10.
The stent lO is maintained in its fully contracted position by an elongated sheath 20 having a tu~ular shape. The sheath 20 has an inside diameter su~stantially equal to t~e outside diameter of the stent 10 in its fully retracted condition.
The spool 12 and stent lO are located within the sheath 20, with the outer surface of the stent 10 in contact with the inside 6 ;
.. ,',' ' ` SUBSTITlJTE SHEEl' ~, ' . ', ' . ,' .. .. . , ' ' ' WO94/03128 PCT/US93/06~97 1 8 ~ 3 surrace of the sheath 20. ~he sheath 20 has 2 llb~'ar for~ in order to receive the stent '0 and spool 12. The outside diameter of the sheath ~0 is preferably s~mewhat smaller ~han the body passa~e in which the stent 10 is t~ be implanted. ~he spool 12 and sheath 20 are 1Qn~ enou~h that they can be advanced into a vessel to the area which is to be ~reated ~ith the stent while the ends remain outside of the booy.
In use, the sheath 20, ~ith the stenl 10 and spool 1 inside of it, is inserted ~nto the body and advanced until its end is adjacent t~ an area or ~ ko~y ~assaqe in ~hiC.q 'Lle s~ent is to be implanted. For example, ~ith reference to Fig. -, .he sheath 20 may be inserted through a ~lood vessel 22 until the leading end of the sheath is adjacent to the dama~ed area such as the stricture 24. The advance of the sheath 20 is then stopped, and the tu~e 12 is advanced while the sheath 20 remains stationary. As the tu~e is thus pushed out through the end of the sheath 20, the spool carries the stent 10 with it because the flange 14 pushes .he stent forwardly along with the spool. Once the flange 14 and the entirety of the stent 10 have cleared the end of the sheath 20 in the position shown in ~roken lines in Fig. 2, there is no longer anythinq restraining the sten~ 10 against expansion. At this time, the stent is aligned with the stricture 24.
Because the stent i5 no longer held against expansion, it expands naturally under the influence of its inherent spring force to the full diameter of the vessel 22. In the fully expanded condition of the stent shown in Fig. 3, its outside surface ! `
~^~ SUBSTITUTE SHEET
WO~4/03128 PCT/US93/06597 con~acts the inside surface sf the ~essel ~all ~nd effec~s expansion of the stricture 24.
It is noteworthy that the sheet construction of the sten~
10 allows it to line the en~iretv or the damaged surrace of the vessel 22 at the stricture ~4 and the adjacent areas of the vessel -~all. Tn this manner, the sten~ is able to remove the occlusion in the vessel that is c~used by the stricture 24 and is also able to reinfor~e and stren~hen the damaged vessel area at and near the strict~:re 2~. Normal ciroulation ~hrouqh the -~essel is thus _eslored. ~athe_ 'han holding ~he shea~h 20 stationary an~ ?ushina .he stent out through its end, _~e sheat~ can be advanced until the stent is aligned with the damaged area, and the sheath can then be retracted while the spool 12 and sten~ 10 are held stationary.
Wh~n tbe sheath is withdrawn far enou~h ~o release the stent, the stent expands in the manner previously indicated.
In the fully expanded condition of the stent, there are prefera~ly at least two overlapping layers which bear against one another and are held against one another by friction c~used by the tendency of the stent to expand to its undeformed condition. These overlapping layers assure that the stent will be securely held in place and provide enhanced structural integrity by reason of the multiple layer structure that is implanted in the damaged area of the vessel. Once the stent has fully expanded, the sheath 20 and the tuba 12 can be removed from the vessel, along with the guide wire 18. In its fully expanded condition, the diameter of the stent is at least as great as the inside diameter of the vessel so .
~ SUBSTITUTE SHEET
WO94/~3128 PCT~US93/06~97 1S~3 .~.
..
that when the s~ent expands into con~ac_ iith the damaged vessel -~all, ~t is held securely against the '~ll under the influence of i,s inherent-spring force.
Fig. ~ depicts an ar~angemenl ~hich ~s for the most ~art identical to that shown in Figs. 1-3. ~~e principal difference is that the Fig. 1 construction has a s?ool 1~ which is pr~vided with a nu~er of spaced apart sten~s 10 car-ied adjacent to different flanges 14. In use of the embodiment snown in Fig. ~, the stents 10 are applied in series to dif erent ~ezkened or damaaed areas of the vessel 2~, ~hereby strength_ning .he iifferent damaqed areas or ... .
the vessel t3 which the stents are appl_ed. ~irtuall~ any desired number of stents can be carried on the spool 12.
Figs. ~ and 6 depict an alternative embodimen~ of the invention in which the sheath 20 is not ~resent. In place of the sheath, the function of holding the roll 13 in its contracted condition is performed by a pair of control cords 26. One of the control cords 26 is fitted through the flange 14 and is provided with a slip knot 28 which is formed adjacent to the flange and which bears against the outer layer of the stent 10 in a manner to prevent the stent from expanding. The other control cord 26 is extended through a second flange 30 which is spaced from flange 14 a distance slightly greater than the length of the stent 10. The .
ends of the cords 26 opposite the slip knots 28 remain outside the i vessel.
In use of the embodiment shown in Figs. 5 and 6, the spool 12 is extended into the vessel un~il the stent 10 is aligned -,., . S~IBSTITUTE SHEE~T
~ith the stricture 24. ~hen, the control cords 26 are ~ulled to ~ -elease the slip knots 28, thereby releasinq the stent 10 ~hich ¦ -hen expands naturally under the influence of .he internal spring force to which it is su~jected. ~he stent expands to t~e rully - expanded condition shown in Fig. 6 ~n ~hich it expands the 'r stricture 24 and eliminates the oc~lusion presented by the stricture. In addition, the stent lO lines _he vessel and strengthens and reinforces the damaged vessel wall in the area of the stricture in the same manner indicated ~re~iously. Once the stent has been fully expanded, ~he spool 12 and ~uide wire 1a can be withdrawn from the vessel. ;
From the foregoing, it will ~e seen that this invention ~- is one well adapted to attain all the ends and o~jects hereinabove set forth together with other advantages which are obvious and which are inherent to the structure.
It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims.
Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein se~ forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.
-: 10 '.
, ;,j .
SUBSTITUTE SHEET
. Field of the ~n~ention This invention relates in general to the rield or medical implants and more particularly to a s.ent which ~s constr~cted in an improved manner for simple and ef'ecti~e placement in a body - passage to reLnforce a damaged area.
Bac~round of the Inventi~
Tubular prostheses commonlv known as stents have been used ts reinrorce and strenalhen dama~ed ~lood vessels and other body passages. For example, .he blood ~essels can collapse, - dilate, become partially occL~ded or otherwise damaged by disease or other causes. The presence of an aneurysm~or stricture in the blGod vessel often requires implzmtation of a stent to strengthen ;~ the vasc~lar wall in the area of the damage. Other passages in the ody can also sometimes benefit from stent implantation, including .
the esophagus, the trachea, the gastro intestinal tract, the bile duct, _he ureter and the urethra.
The benefits of self-expanding stents have been recognized. A self-expanding stent is held in a contracted state until it has been positioned properly, typically with t~e aid of an instrument such as a catheter. After the stent has been placed properly in the damaged blood vessel, it is allowed to expand against the damaged vessel wall in order to reinforce the damaged ' - area. Examples of self-expanding stents are disclosed in U.S.
Patent Nos. 5,026,377 and 5,078,720 to Burton et al., U~S. Patent :
,.
SUBSTITUTE SHEET
W094tO3128 PCT/US93/06S97 ~o. ~,019,085 to Hillstead, -J.S. Patent ~o. ~,969,~58 to Wiktor, and U.S. Patent ~o. ~,041,126 to Gianturco. The ~ic~tcr ~nd Gianturco stents are in the form of coiled or looped wires that are unable to conlact the entirety of the weakened vessel wall. The ~;
same is true of the Hillstead stent ~hich takes the form of a multiple loop wire structure. The st nts disclosed in _he ~-~o ~-Burton patents are braided structures that are likewise incapable of contacting the enti~ety of the damaqed vessel wall. ~ll of the -~stents and particularly their placement means are com~licated to construc-, ~nd the stents are di.f~cult t~ place orecisely ~n the damaqed ~essel.
Summar~ of_the In~ention The present invention is directed to an improved stent whIch is particularly characterized by a stronger construction, the a~ility to provide a solid and continuous wall that lines the ; entirety of the damaged part of passage wall in which t is implanted, and by ease and accuracy of placement. In accordance with the invention, a stent is provided in the form of a flexible metal sheet which i5 closely wound around a spool in a spinal roll.
- A sheath initially surrounds the roll in order to retain it in a contracted state. The spool, stent and sheath can be inserted together into the body with the spool following a guide wire until it is located adjacent to the damaged area. Then, the sheath is , held stationary while the spool is pushed out the end of the --! sheath, with a flange on the spool making certain that the tightly coiled roll remains on the spool. Once the spool has cleared the ;, , i ;
,~
:i SUBSTITUTE SHEET
~ WO94/03128 2 1 4 1 ~ 7 3 PCT/US93/06597 I sheath, the roll is released and allowed to expand against the damaged ~all of the vPssel. The sheath and spool c n then be 3 - withdrawn, lea~ing tAe stent in place.
An alternative embodiment of the invention elimina~es the ` sheath and instead holds the stent in its retracted state by means -j of a pair of control cords which are connected by slip knots to -, flanges on the spool located adjacent to the opposite ends of the stent. When the stent has been properly positioned, the cords can be pulled to release the slip knots and allow the stent to expand - against the vessel wall. _a both embodimenls, multiple s.en~s can , be carried on the same s~ocl ,f it is necessary tO s~ren~then the vessel in more than one area.
Because the stent takes the form of a continuous sheet, the stent essentially contacts the entirety of the damaged vessel wall area, rather than simply reinforcing the damaged area as is t~e case with looped or coiled wires or braided netting type - structures. In addition, the stent preferably has multiple l~yers ., that bear against one another whem the stent is in its expanded condition. This further enhances the strength of the stent and provides multiple layers that are held against one another by friction resulting from the tendency for the stent to expand under the influence of internal spring force.
The method by which the stent is placed in the proper position and allowed to expand against the vessel wall is improved in a num~er of respects compared to what has been proposed in the past. The placement method is simple and accurate and does not ,',',.'' :' SUBSTITUTE SHEET
W094~03128 PCT/US93/06597 ~ 4.~ ~ 3 involve complexities such as the need to inflate a balloon c-~theter ~ or other mechanism.
- Description of the Drawin~s .1 In t~e accompanying drawings which form a part of the specification and are to be read in conjunction therewith and in ; which like reference numerals are used to indicate liXe parts in i the various views: -Fig. 1 is a fragmentary perspecti~e view of a s.ent and Dlacement system for the s~ent, all constructed ac~ording to a preferred em~odiment ~f t.~e ~resent invention, ~ith the stent in i~s retracted condition and part of '.~e sheath shown in section for purposes of illustration;
Fig. 2 is a fragmentary sectional view illustrating the stent being applied to a stricture in a blood vessel, with the broken lines depicting the spool and stent pushed out the end of ~ the sheath;
-- Fig. 3 is a fragmentary sectional view similar to Fig. 2, but showing the stent expanded against the damaged vessal wall prior to withdrawal of the sheath and spool;
Fig. 4 is a fragmentary sectional view showing an alternative embodiment of the invention in which the spool is constructed to carry multiple stents and to apply them to multiple damaged areas of a blood vessel;
Fig. 5 is a fragmentary sectional view of a stent arrangement constructed according to an alternative embodiment of the invention, with the stent in its retracted condition and .,.. ,., :
WO94/03128 PCT/~S93/06597 2 ~ 7 3 j posi~ioned properly f~r application to a dama~ed str~ure in a j blood vessei; and ~ Fig. 5 is a fraqmentary s~cti~al ~iew similar _a Fig. 5, 3 but showing the stent released and expanded against the aamaged ¦ vesse~ wall pri~r to withdrawal of the spool.
Detailed Description of t~e_Invention Referring now t~ the drawings in more detail and initially to Fig. l in particular, numeral 10 generally designates a stent which ~s constructed in ac~ordance with 2 ?referred embodiment cr 'he present inven~ion. ~he stent 10 takes ~he form of an initially flat metal sheel .Jhic~ is wound tightly around a core which is in the form of a tu~ular spool 12. The stent 10 is ~ preferably constructed of a stainless steel foil which is ;;~ commercially available under the trade designation PH15-7, Condition C~900. The thic~ness of the sheet ll is preferably about .0005 inch. When the sheet ll is coiled around the spool 12, it is in the shape of a spiral roll 13, and its outside diameter may be approximately 1.5 millimeter. The sheet 11 is long enou~h that there are approximately six or seven !ayers of the sheet which overlap one another when the roll 13 is in the contracted position shown in Figs. 1 and 2.
The sheet ll produces an innerent spring force which tends to expand the sheet from the retracted condition of the roll 13. ~y way of example, it is contemplated that the sheet will ~, initlally be rolled to a diameter of approximately S millimeters and then heat treated in that condition in order to relax the ~ `'`' ,..
, ~ SUBSTITUTE SHEET ::
WO94/03128 PCT/US93/06~97 7,3 internal stresses that are i~duced ~ windir.g .he shee~ ~o 2 ~artially contrac~ed condition. Followin~ the hea~ treatment, the ~aterial can be rolled into the tighter oll 13 (approximately 1.5 ~illimeter in diameter), and the ~oll will have fewer internal stresses than if it were initi~lly ~ound into the tight 1.5 ~illimeter cylinder. The internal spring force of the roll 13 will tend to cause it to unwind to an expanded condition in ~hich its diameter i5 approximately 5 millimeters (the diameter at -~hich the heat ~reatment takes place).
The sheet 11 is wound ~ightli ~n _he s~ool 12 near one end of the spool, and one end of the roll 13 butts a~ainst a flange 14 which is formed on the spool 12 at ~ location spaced rrom t~e end of the spool. The flange 14 projects radially from the spool 12 and has a diameter approximately equal to the diameter of the stent 10 in its ful1y contracted condition. The flange 14 is spaced from the end of the spool a distance greater than the axial length of the stent 10. The spool 12 is provided with a central axial passaqe 16 which receives a quide wire 13. As will be explained more fully, the spool 12 can be moved along the ~uide wire 18 in order to properly position the stent 10.
The stent lO is maintained in its fully contracted position by an elongated sheath 20 having a tu~ular shape. The sheath 20 has an inside diameter su~stantially equal to t~e outside diameter of the stent 10 in its fully retracted condition.
The spool 12 and stent lO are located within the sheath 20, with the outer surface of the stent 10 in contact with the inside 6 ;
.. ,',' ' ` SUBSTITlJTE SHEEl' ~, ' . ', ' . ,' .. .. . , ' ' ' WO94/03128 PCT/US93/06~97 1 8 ~ 3 surrace of the sheath 20. ~he sheath 20 has 2 llb~'ar for~ in order to receive the stent '0 and spool 12. The outside diameter of the sheath ~0 is preferably s~mewhat smaller ~han the body passa~e in which the stent 10 is t~ be implanted. ~he spool 12 and sheath 20 are 1Qn~ enou~h that they can be advanced into a vessel to the area which is to be ~reated ~ith the stent while the ends remain outside of the booy.
In use, the sheath 20, ~ith the stenl 10 and spool 1 inside of it, is inserted ~nto the body and advanced until its end is adjacent t~ an area or ~ ko~y ~assaqe in ~hiC.q 'Lle s~ent is to be implanted. For example, ~ith reference to Fig. -, .he sheath 20 may be inserted through a ~lood vessel 22 until the leading end of the sheath is adjacent to the dama~ed area such as the stricture 24. The advance of the sheath 20 is then stopped, and the tu~e 12 is advanced while the sheath 20 remains stationary. As the tu~e is thus pushed out through the end of the sheath 20, the spool carries the stent 10 with it because the flange 14 pushes .he stent forwardly along with the spool. Once the flange 14 and the entirety of the stent 10 have cleared the end of the sheath 20 in the position shown in ~roken lines in Fig. 2, there is no longer anythinq restraining the sten~ 10 against expansion. At this time, the stent is aligned with the stricture 24.
Because the stent i5 no longer held against expansion, it expands naturally under the influence of its inherent spring force to the full diameter of the vessel 22. In the fully expanded condition of the stent shown in Fig. 3, its outside surface ! `
~^~ SUBSTITUTE SHEET
WO~4/03128 PCT/US93/06597 con~acts the inside surface sf the ~essel ~all ~nd effec~s expansion of the stricture 24.
It is noteworthy that the sheet construction of the sten~
10 allows it to line the en~iretv or the damaged surrace of the vessel 22 at the stricture ~4 and the adjacent areas of the vessel -~all. Tn this manner, the sten~ is able to remove the occlusion in the vessel that is c~used by the stricture 24 and is also able to reinfor~e and stren~hen the damaged vessel area at and near the strict~:re 2~. Normal ciroulation ~hrouqh the -~essel is thus _eslored. ~athe_ 'han holding ~he shea~h 20 stationary an~ ?ushina .he stent out through its end, _~e sheat~ can be advanced until the stent is aligned with the damaged area, and the sheath can then be retracted while the spool 12 and sten~ 10 are held stationary.
Wh~n tbe sheath is withdrawn far enou~h ~o release the stent, the stent expands in the manner previously indicated.
In the fully expanded condition of the stent, there are prefera~ly at least two overlapping layers which bear against one another and are held against one another by friction c~used by the tendency of the stent to expand to its undeformed condition. These overlapping layers assure that the stent will be securely held in place and provide enhanced structural integrity by reason of the multiple layer structure that is implanted in the damaged area of the vessel. Once the stent has fully expanded, the sheath 20 and the tuba 12 can be removed from the vessel, along with the guide wire 18. In its fully expanded condition, the diameter of the stent is at least as great as the inside diameter of the vessel so .
~ SUBSTITUTE SHEET
WO94/~3128 PCT~US93/06~97 1S~3 .~.
..
that when the s~ent expands into con~ac_ iith the damaged vessel -~all, ~t is held securely against the '~ll under the influence of i,s inherent-spring force.
Fig. ~ depicts an ar~angemenl ~hich ~s for the most ~art identical to that shown in Figs. 1-3. ~~e principal difference is that the Fig. 1 construction has a s?ool 1~ which is pr~vided with a nu~er of spaced apart sten~s 10 car-ied adjacent to different flanges 14. In use of the embodiment snown in Fig. ~, the stents 10 are applied in series to dif erent ~ezkened or damaaed areas of the vessel 2~, ~hereby strength_ning .he iifferent damaqed areas or ... .
the vessel t3 which the stents are appl_ed. ~irtuall~ any desired number of stents can be carried on the spool 12.
Figs. ~ and 6 depict an alternative embodimen~ of the invention in which the sheath 20 is not ~resent. In place of the sheath, the function of holding the roll 13 in its contracted condition is performed by a pair of control cords 26. One of the control cords 26 is fitted through the flange 14 and is provided with a slip knot 28 which is formed adjacent to the flange and which bears against the outer layer of the stent 10 in a manner to prevent the stent from expanding. The other control cord 26 is extended through a second flange 30 which is spaced from flange 14 a distance slightly greater than the length of the stent 10. The .
ends of the cords 26 opposite the slip knots 28 remain outside the i vessel.
In use of the embodiment shown in Figs. 5 and 6, the spool 12 is extended into the vessel un~il the stent 10 is aligned -,., . S~IBSTITUTE SHEE~T
~ith the stricture 24. ~hen, the control cords 26 are ~ulled to ~ -elease the slip knots 28, thereby releasinq the stent 10 ~hich ¦ -hen expands naturally under the influence of .he internal spring force to which it is su~jected. ~he stent expands to t~e rully - expanded condition shown in Fig. 6 ~n ~hich it expands the 'r stricture 24 and eliminates the oc~lusion presented by the stricture. In addition, the stent lO lines _he vessel and strengthens and reinforces the damaged vessel wall in the area of the stricture in the same manner indicated ~re~iously. Once the stent has been fully expanded, ~he spool 12 and ~uide wire 1a can be withdrawn from the vessel. ;
From the foregoing, it will ~e seen that this invention ~- is one well adapted to attain all the ends and o~jects hereinabove set forth together with other advantages which are obvious and which are inherent to the structure.
It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims.
Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein se~ forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.
-: 10 '.
, ;,j .
SUBSTITUTE SHEET
Claims (17)
1. A stent assembly for placement in a body passage to reinforce a damaged wall in the passage, comprising:
an elongated core;
an elongated, flexible sheet arranged on said core in a multiple layer roll having expanded and contracted conditions and being urged toward the expanded condi-tion, said roll being tightly wound on the core in the contracted condition and presenting in the expanded condition a diameter at least equal to the diameter of the body passage, said roll being spirally wound on said core and having an inherent spring force tending to expand the roll, said roll presenting a plurality of adjacent, arcuate layers of said sheet in a direction transverse to the longitudinal axis of said core;
releasable means for retaining said roll in the contracted condition on said core while the core is being inserted into the passage to the location of the damaged walls; and means for effecting release of said releasable means to permit the roll to expand against the damaged wall in the expanded condition of the roll, said roll in the expanded condition thereof having at least an inner and an outer layer which overlap and bear against one another over a substantial portion of the circumference of the inner layer, said expanded roll securely contacting said damaged wall by virtue of said inherent spring force of the roll.
an elongated core;
an elongated, flexible sheet arranged on said core in a multiple layer roll having expanded and contracted conditions and being urged toward the expanded condi-tion, said roll being tightly wound on the core in the contracted condition and presenting in the expanded condition a diameter at least equal to the diameter of the body passage, said roll being spirally wound on said core and having an inherent spring force tending to expand the roll, said roll presenting a plurality of adjacent, arcuate layers of said sheet in a direction transverse to the longitudinal axis of said core;
releasable means for retaining said roll in the contracted condition on said core while the core is being inserted into the passage to the location of the damaged walls; and means for effecting release of said releasable means to permit the roll to expand against the damaged wall in the expanded condition of the roll, said roll in the expanded condition thereof having at least an inner and an outer layer which overlap and bear against one another over a substantial portion of the circumference of the inner layer, said expanded roll securely contacting said damaged wall by virtue of said inherent spring force of the roll.
2. The stent assembly of claim 1, including a first flange on said core against which one end of said roll is engaged in the contracted condition.
3. The stent assembly of claim 2, including a second flange on said core, said roll being retained between the first mentioned flange and said second flange in the contracted condi-tion.
4. The stent assembly of claim 3, wherein said releasable means comprises a pair of control cords having slip knot connections with the respective first and second flanges arranged in a manner to retain the roll in the contracted condition, said slip knot connections being releasable upon pulling of said control cords to thereby release said roll for expansion thereof to the expanded condition.
5. The stent assembly of claim 4, wherein said core comprises a hollow spool having na axial passage therethrough for receiving a guide wire along which the spool may be guided to the location of the damaged wall.
6. The stent assembly of claim 1, wherein said core comprises a hollow spool having na axial passage therethrough for receiving a guide wire along which the spool may be guided to the location of the damaged wall.
7. The stent assembly of claim 1, wherein said sheet is constructed of a think metal foil.
8. The stent assembly of claim 1, wherein said sheet is constructed of a think stainless steel foil.
9. The stent assembly of claim 1, wherein said releasable means comprises a sheath closely sleeved on said roll, said sheath being movable axially relative to said core to release from the roll.
10. The stent assembly of claim 1, including:
a second flexible sheet arranged on said core in a second multiple layer roll spaced from the first mentioned roll, said second roll having a contracted condition wherein the second roll is tightly wound on the core and an expanded condition wherein the second roll presents a diameter, substantially equal to the diameter of the body passage, said second roll being urged toward the expanded condition;
releasable means for retaining said second roll in the con-tracted condition; and means for effecting release of the releasable means for said second roll.
a second flexible sheet arranged on said core in a second multiple layer roll spaced from the first mentioned roll, said second roll having a contracted condition wherein the second roll is tightly wound on the core and an expanded condition wherein the second roll presents a diameter, substantially equal to the diameter of the body passage, said second roll being urged toward the expanded condition;
releasable means for retaining said second roll in the con-tracted condition; and means for effecting release of the releasable means for said second roll.
11. The stent assembly of claim 10, wherein the releasable means for the first and second rolls comprises a sheath closely sleeved on the first and second rolls, said sheath being movable axially relative to said core to release from the first and second rolls in succession.
12. Apparatus for reinforcing a damaged wall of a body passage, comprising:
an elongated core;
an elongated stent in the form of a flexible sheet spirally wound around the core in a multiple layer roll having contracted and expanded conditions, said sheet being wound tightly on the core in the contracted condition and being biased having an inherent spring force biasing the roll to expand toward the expanded condi-tion thereof wherein the sheet assumes a size to contact the damaged wall, and said roll presenting a plurality of adjacent, arcuate layers of said sheet in a direction transverse top the longitudinal axis of the core;
a sheath fitting closely around said roll to hold the sheet in the contracted condition, said sheath being movable axially relative to the roll to permit the sheath to release from the roll and thereby allow expansion of the sheet against the damaged wall in the expanded condition, said roll in the expanded condition thereof having at least an inner and an outer layer which overlap and bear against one another over a substantial portion of the circumference of the inner layer, said expanded roll securely contacting said damaged wall by virtue of said inherent spring force of the roll.
an elongated core;
an elongated stent in the form of a flexible sheet spirally wound around the core in a multiple layer roll having contracted and expanded conditions, said sheet being wound tightly on the core in the contracted condition and being biased having an inherent spring force biasing the roll to expand toward the expanded condi-tion thereof wherein the sheet assumes a size to contact the damaged wall, and said roll presenting a plurality of adjacent, arcuate layers of said sheet in a direction transverse top the longitudinal axis of the core;
a sheath fitting closely around said roll to hold the sheet in the contracted condition, said sheath being movable axially relative to the roll to permit the sheath to release from the roll and thereby allow expansion of the sheet against the damaged wall in the expanded condition, said roll in the expanded condition thereof having at least an inner and an outer layer which overlap and bear against one another over a substantial portion of the circumference of the inner layer, said expanded roll securely contacting said damaged wall by virtue of said inherent spring force of the roll.
13. Apparatus as set forth in claim 12, including a flange on said core against which one end of said roll is engaged in the contracted condition.
14. Apparatus as set forth in claim 12, wherein said core comprises a spool having an axial passage therethrough for receiving a guide wire along which the spool may be guided to the location of the damaged wall.
15. Apparatus as set forth in claim 12, wherein said sheet is constructed of a thin metal foil.
16. Apparatus as st forth in claim 12, wherein said sheet is constructed of a thin stainless steel foil.
17. Apparatus as set forth in claim 12, including a second stent in the form of a second flexible sheet wound around said core in a second multiple layer roll having contracted and expanded conditions, said second sheet being wound tightly on the core in the contracted condition and being biased toward the expanded condition wherein said second sheet assumes a size to contact the passage wall, said sheath fitting closely on the second roll to hold the second sheet in the contracted condition and being movable axially to release from the second roll and thereby allow the second roll to expand against the wall in the expanded condition.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/925,959 | 1992-08-05 | ||
US07/925,959 US5306294A (en) | 1992-08-05 | 1992-08-05 | Stent construction of rolled configuration |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2141873A1 true CA2141873A1 (en) | 1994-02-17 |
Family
ID=25452493
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002141873A Abandoned CA2141873A1 (en) | 1992-08-05 | 1993-07-14 | Stent construction and placement method |
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US (3) | US5306294A (en) |
EP (1) | EP0653925A4 (en) |
AU (1) | AU4772693A (en) |
CA (1) | CA2141873A1 (en) |
WO (1) | WO1994003128A1 (en) |
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- 1993-07-14 WO PCT/US1993/006597 patent/WO1994003128A1/en not_active Application Discontinuation
- 1993-07-14 CA CA002141873A patent/CA2141873A1/en not_active Abandoned
- 1993-07-14 EP EP93918189A patent/EP0653925A4/en not_active Withdrawn
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-
1996
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US5306294A (en) | 1994-04-26 |
USRE35988E (en) | 1998-12-08 |
WO1994003128A1 (en) | 1994-02-17 |
EP0653925A1 (en) | 1995-05-24 |
AU4772693A (en) | 1994-03-03 |
US5411551A (en) | 1995-05-02 |
EP0653925A4 (en) | 1995-08-09 |
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Legal Events
Date | Code | Title | Description |
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EEER | Examination request | ||
FZDE | Discontinued |