CA2030196C - Biological duct liner and installation catheter - Google Patents
Biological duct liner and installation catheterInfo
- Publication number
- CA2030196C CA2030196C CA002030196A CA2030196A CA2030196C CA 2030196 C CA2030196 C CA 2030196C CA 002030196 A CA002030196 A CA 002030196A CA 2030196 A CA2030196 A CA 2030196A CA 2030196 C CA2030196 C CA 2030196C
- Authority
- CA
- Canada
- Prior art keywords
- tube
- catheter
- liner
- compressible
- split
- 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.)
- Expired - Fee Related
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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
- A61F2/95—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
- A61F2/82—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
Abstract
An apparatus for correcting narrowing of a fluid vessel of the body comprising a catheter, for insertion into the blood vessel at a location remote from a region of narrowing, and a fluid vessel liner.
The liner is comprised of a radially resiliently compressible tube having an elongated split along one side thereof. The edges of the sides of the liner on each side of the split overlap each other. The liner is contained within the catheter adjacent a tip of the catheter in a compressed condition. The catheter is constructed for expulsion of the liner from the catheter forward of the catheter at the region of narrowing, thereby facilitating expansion of the tube to a natural expanded condition so as to support the blood vessel from the interior to the diameter of the tube in its naturally expanded diameter.
The liner is comprised of a radially resiliently compressible tube having an elongated split along one side thereof. The edges of the sides of the liner on each side of the split overlap each other. The liner is contained within the catheter adjacent a tip of the catheter in a compressed condition. The catheter is constructed for expulsion of the liner from the catheter forward of the catheter at the region of narrowing, thereby facilitating expansion of the tube to a natural expanded condition so as to support the blood vessel from the interior to the diameter of the tube in its naturally expanded diameter.
Description
` 2030196 01 This invention relates to a catheter, and 02 in particular to a catheter for installing a liner or 03 sleeve device in an artery or other biological duct in 04 order to maintain it permanently or temporarily in a 05 dilated state.
06 One of the techniques used for clearing 07 blocked arteries, for example, arteries clogged by 08 cholesterol, is to insert a catheter to the site of 09 the blockage. The end of the catheter is then expanded, e.g. by expansion of a balloon at the site 11 of the blockage. This expansion compresses the 12 cholesterol, allowing the passage of blood. However 13 this technique has not always worked, and in addition, 14 another build-up often occurs at the same site which again blocks the artery.
16 In order to ensure that the artery is 17 maintained in an expanded state, Dominic M. Wiktor, in 18 U.S. Patent 4,649,922 issued March 17th, 1987, 19 describes a catheter which contains a balloon for compressing chole~terol, the catheter bein~ ~truct~lre~
21 so that a liner formed of stainless steel spring is 22 deployed at the site of the blockage, and is 23 maintained in place after the catheter has been 24 removed. However this structure, using a helical spring, has a diameter that must be narrower than the 26 artery itself in order to be inserted. Yet due to the 27 structural form of the catheter the spring, is wider 28 in diameter before deployment than after deployment, 29 and in its widest diameter state is significantly narrower than the artery itself. It cannot expand to 31 an optimal diameter in order to maintain the interior 32 of the artery to an optimal diameter.
33 The present invention is a biological 34 vessel sleeve- which is inserted in place while maintaining a diameter which is narrower than the 36 duct, but expands to an optimal diameter which is 37 significantly greater than its diameter during 20301g6 insertion.
In addition, the sleeve is coated by a material which rejects adhesion by blood of cholesterol, the coating being preferably TeflonT~.
One embodiment of the invention is a fluid vessel liner cmoprised of a compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other.
In accordance with another embodiment, a biological fluid vessel liner forming a sleeve comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, a tube being covered on all surfaces with polytetra-fluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be permanently bent away from a linear axis.
In accordance with another embodiment, apparatus for correcting narrowing of a fluid vessel of a biological body comprising a catheter, for insertion into the blood vessel at a location remote from a region of narrowing, a fluid vessel liner comprised of a radially resiliently compressible tube having an elongated split along one side thereof and the edges of the sides of the linear on each side of the split overlapping each other contained within the catheter adjacent a tip of the catheter in a compressed condition, means for expulsion of the liner from the catheter forward of the catheter at the region of narrowing, and means for facilitating expansion of the tube to a natural expanded condition thereby to support the blood vessel from the interior to the diameter of the tube in its naturally expanded diameter, in which the tube is formed of magnetically attractable metal, and in which the means for facilitating expansion is comprised of an electromagnet for containment within the tube, and for attracting and radially compressing the compressible tube thereto by means of a controllable electromagnetic field when the tube is contained within the catheter, and for releasing the compressible tube by liquidating the electromagnetic field when the compressible tube is in a deployment position at the region of narrowing, thus allowing the compressible tube to expand to a predetermined diameter.
In accordance with another embodiment, a method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter, in which the liner is formed of SS a longitudinally split tube of magnetic material having overlapping edges along the split, the contracting step being comprised of applying a magnetic field to the material to cause radial contraction and overlap of the overlapping edges additional to the overlap achieved in the absence of said field.
In accordance with another embodiment, a method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter in which the liner is comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, the tube being covered on all surfaces with polytetra-fluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be bent away from a linear axis.
- 2a -~' 03 While the description herein may appear to 04 be mainly directed to application to blood ves.sels, 05 the invention is not intended to be so limited. The 06 invention i8 equally applicable to all biological 07 ducts, including urological ducts.
08 A better understanding of the invention 09 will be obtained upon reading the description below, in conjunction with the following drawings, in which:
11 Figures 1-4 are isometric views of various 12 types of biological sleeves, as contemplated by the 13 present invention, 14 Figure 5 is an end view of a biological sleeve as contemplated in the present invention, 16 Figure 6 is a partly sectional view of the 17 end of a catheter containing the biological sleeve, 18 prior to deployment, 19 Figure 7 is a cross-sectional view along 20 section X-X of Figure 6, 21 Figure 8 is a partly sectional view of a 22 catheter in accordance with the present invention of a 23 type designed to retrieve an alrçady deployed sleeve, 24 and Figure 9 is a cross-section along section 26 Y-Y of Figure 8.
. 27 Turning now to Figures 1-5, a sleeve 1 28 formed of a cylinder of spring sheet stainless steel 29 coated with Teflon~ (polytetrafluoroethylene) is shown. The cylinder is axially slit, the edges along 31 the slit overlapping as shown at 2. It may be seen 32 that the sleeve can be radially compressed, and will 33 spring back. to a predetermined diameter, due to the 3~ . spring nature of the stainless steel. An outer side of the sleeve 10 can slip past an inner side of the 36 sleeve 9, during compression. In.the embodiment sho.wn 37 in Figure 1, the surfaces of the sleeve are smooth and 01 are not generally perforated.
02 The embodiment shown in Figure 2 cont-ains 03 circular corrugations 3. This allows the sleeve to be 04 bent permanently. Prior to deployment, however, the 05 sleeve is straightened against the spring tendency to '06 maintain it in the bent position. It will ,be 07 temporarily maintained in its straightened position 08 within the deployment catheter to be described below.
09 The embodiment shown in Figure 3 is formed of stainless steel mesh 5, which can be used in a 11 biological duct in which the maximum interior surface 12 area of the duct must be exposed. The embodiment of 13 Figure 4 is formed of stainless steel spring sheet 14 which has been punched with a large number of holes 7. This structure provides more strength than the 16 structure of Figure 3, but allows significant areas of 17 the inner surface of the biological duct to be exposed 18 to fluids passing therethrough. The embodiments of 19 Figures 3 and 4 can of course contain circular corrugations as in Figure 2, in order that the sleeve 21 can be permanently bent.
- 22 It should be noted that it is possible the 23 sleeves as shown in Figures 3 and 4 will "grow into"
24 (be incorporated into) the wall of the biological duct after some time, and will become an integral part of 26 the duct. This can be better accomplished by not 27 coating the outside of the sleeves with Teflon~.
28 Figure 6 illustrates a sleeve deployment 29 catheter. A cathete~ sleeve 13 contains a plunger head 14, contained at the end of a plunger rod 15.
31 The plun,ger rod can slide within the catheter sleeve 32 13 either by being coupled by a thread 16, the plunger 33 rod rotating within the catheter sleeve, or, if no 34 thread is used, by simple manual sliding manipulation.
A nose cone 17 at the front of the sleeve 36 over the plunger head terminates in a conical tip 18.
01 With additional reference to Figure 7, a 02 sleeve 1 of a type described with reference to Figures 03 1-5 is contained within the nose cone 17, behind the 04 conical tip, in its compressed state. The sleeve is 05 maintained in the compressed state by means of 06 electromagnets 19, which are symmetrically disposed 07 around the axis of the instrument within the sleeve 08 and are fixed to the front of the plunger head 14.
09 The electromagnets can extend over the length of the sleeve, or shorter magnets can be used if sufficient 11 total magnetic strength is used to maintain the sleeve 12 in its compressed condition. Wires 20, used to power 13 the electromagnetics, extend through the plunger head 14 14 and through the catheter, and are coupled to a power supply outside the body of the patient, via a 16 switch (not shown).
17 The conical tip is formed of an inert 18 material 21, and contains at its end adjacent the 19 sleeve 1 and electromagnets 19, a conical chamfer 22.
The end 23 of the plunger head 14 has a diameter of 21 the inner diameter of the nose cone 17 so that it 22 bears against the edge of sleeve 1, which bears 23 against the chamfer 22. A tube 20A extends the length 24 of the catheter. --In operation, the catheter containing the 26 sleeve which is compressed under the influence of the 27 magnetic field of magnets 19 is inserted into the 28 biological duct to be expanded. When near the site to 29 be expanded, dye is inserted into the outer end of tube 20A, and passes down the tube 20A to pass out of 31 the conical tip 18 into the biological duct, so that 32 the restricted area to be expanded can be viewed by 33 X-ray, and thus to ensure that the sleeve is pushed to 34 the correct location.
With the conical tip located just behind 36 the region of the biological duct to be expanded, the 37 plunger rod is moved forward, either by rotating it, 01 and thus thrusting it forward by mutual action of the 02 threading 16, or if threading is not used, by manual 03 movement of the plunger rod within the catheter sleeve 04 13.
05 This causes the plunger head 14 to push 06 the plunger end 23 against the sleeve 1. The sleeve 1 07 and magnets 19, are forced against the inner portion 08 of the conical tip 18. Due to force against the 09 conical chamfer 22, the conical tip 18, which is split in its length at, for example, three locations 120 11 apart, and causes the conical tip 18 to open, hinged 12 at the ends of the chamfer by the resilient plastic 13 material of the conical tip. The sleeve 1, maintained 14 in its compressed position by the electromagnetic field of the electromagnets 19, is pushed out of the 16 catheter, forward of conical tip 18, with its outer 17 surface finally adjacent the inner surface of the 18 biological duct at the location where the biological 19 duct is to be expanded.
The electric current to the 21 electromagnets is then turned off, by opening of the 22 external switch described earlier. With the 23 electromagnetic field thus switched off, the force 24 maintaining the sleeve compressed is removed, and the sleeve expands to its predetermined diameter, under 26 spring tension. The plunger 14 is withdrawn back into 27 the nose cone 17, with the electromagnets fixed to the 28 conical head 23 following. The conical chamfer 22, 29 bearing on the electromagnets allow the jaws of the nose cone to resiliently close toward each other 31 following passage of the electromagnets 19 into the 32 nose cone, allowing the conical tip 18 to close. The 33 jaws of conical tip 18 can be an inert resilient 34 plastics material coupled via integral plastics spring to the remainder of nose cone 17, in a well known 36 manner.
37 With the electromagnets 19 safely - . . 203Q196-01 contained within the catheter, and the nose cone 18 02 closed, the catheter is withdrawn. The sleeve 1, 03 being expanded, both compresses any cholesterol that 04 may be present along the duct wall, and expands the 05 - interior of the biological duct, maintaining it in its 06 expanded condition.
07 In the event the sleeve is to be placed in 08 a biological duct at the location of a bend, the 09 sleeve shown in Figure 2 is used. While it is permanently bent so as to maintain the bent condition 11 under spring loaded tension as described above once 12 deployed, it is resiliently bent into a straight 13 cylindrical form against the spring tension prior to 14 being inserted into the catheter. After deployment and release of the electromagnetic field, the sleeve 16 can assume its permanently bent orientation.
17 Figures 8 and 9 illustrate a catheter for 18 retrieving a sleeve already in position. Illustrated 19 in Figure 8 is a biological duct 25 containing a sleeve 1 that has been previously deployed. While a 21 form of the catheter shown in Figure 6 could be used 22 for retrieval, a modified form of it is preferred to 23 be used as the retrieving catheter, as shown in Figure 24 8.
The catheter is inserted into the 26 biological duct, and to a position just adjacent the 27 front of sleeve 1. A plunger head 14 has attached to 28 the front thereof a set of electromagnets 19 as 29 described earlier. In this embodiment, however, a dye tube is not necessary. In addition, the interior of 31 nose cone 17 contains inwardly directed sloping edges 32 26 to form cam surfaces. The forward end 27 of 33 electromagnets 19 can be smoothly conical in shape.
34 In operation, the plunger head 14 is moved forward, pushing the electromagnets 19 forward. The 36 forward end of the electromagnets come into contact 37 with the sloping edges 26 of the interior of the nose - 2û30196 01 cone 17, forcing the jaws of the~nose cone open. The 02 electromagnets are pushed forward into the interior of 03 the sleeve 1. Due to the opacity of the sleeve 1 and 04 the catheter, the positioning can be seen clearly by 05 X-ray. However in case dye is to be injected, the 06 structure can contain an interior tube 20A as 07 described earlier with respect to Figure 6.
08 Once the electromagnets 19 are in 09 position, with the end of the plunger head against the adjacent end of sleeve 1, the external switch is 11 closed and electric current is applied to the 12 electromagnets 19. The sleeve 1 is attracted to the 13 electromagnet, and compresses by the outer side of the 14 sleeve 10 sliding over the inner side of the sleeve 9 (Figure 5). The sleeve 1 thus is wrapped around the 16 electromagnets 19 in a compressed state, and is 17 magnetically adhered thereto.
18 The plunger rod is then withdrawn, drawing 19 the plunger head, electromagnets and sleeve into the nose cone 17. As the outer edge of sleeve 1 and the 21 forward end 27 of the electromagnets pass the sloping 22 edges 26 of the interior of the conical tip 18, the 23 jaws of the conical tip close. The sleeve is thus 24 safely contained within the catheter. The catheter is then withdrawn from the biological duct with the 26 sleeve.
27 It is preferred that three identical 28 electromagnets 19 symmetrically located about the axis 29 of the catheter should be used, preferably insulated from each other by means of inert resilient insulation 31 28. The wires 20 can pass through the insulation 28 32 parallel to the axis of the catheter in order to 33 connect to electromagnetic field generating coils 34 forming part of the electromagnets 19. In addition, a center core 29 of the electromagnets can be filled 36 with inert resilient material, such as silicone 37 rubber, and may contain the wires~.
.
01 It should be noted that the catheter 02 sleeve can be used to insert an ultrasonic transducer, 03 such as a miniature quartz crystal, into the 04 biological duct, in place of the conical tip. Wires 05 for operating the transducer can be passed through the 06 catheter to imaging electronics outside the body. The 07 head can be used for imaging the interior of the duct, , 08 and surrounding structures.
09 A person skilled in the art understanding the present invention may now conceive of variations 11 o,r other embodiments using the concepts described 12 herein, such as other means for compressing the 13 sleeve. All are considered to be within the sphere 14 and scope of the invention as defined in the claims appended hereto.
06 One of the techniques used for clearing 07 blocked arteries, for example, arteries clogged by 08 cholesterol, is to insert a catheter to the site of 09 the blockage. The end of the catheter is then expanded, e.g. by expansion of a balloon at the site 11 of the blockage. This expansion compresses the 12 cholesterol, allowing the passage of blood. However 13 this technique has not always worked, and in addition, 14 another build-up often occurs at the same site which again blocks the artery.
16 In order to ensure that the artery is 17 maintained in an expanded state, Dominic M. Wiktor, in 18 U.S. Patent 4,649,922 issued March 17th, 1987, 19 describes a catheter which contains a balloon for compressing chole~terol, the catheter bein~ ~truct~lre~
21 so that a liner formed of stainless steel spring is 22 deployed at the site of the blockage, and is 23 maintained in place after the catheter has been 24 removed. However this structure, using a helical spring, has a diameter that must be narrower than the 26 artery itself in order to be inserted. Yet due to the 27 structural form of the catheter the spring, is wider 28 in diameter before deployment than after deployment, 29 and in its widest diameter state is significantly narrower than the artery itself. It cannot expand to 31 an optimal diameter in order to maintain the interior 32 of the artery to an optimal diameter.
33 The present invention is a biological 34 vessel sleeve- which is inserted in place while maintaining a diameter which is narrower than the 36 duct, but expands to an optimal diameter which is 37 significantly greater than its diameter during 20301g6 insertion.
In addition, the sleeve is coated by a material which rejects adhesion by blood of cholesterol, the coating being preferably TeflonT~.
One embodiment of the invention is a fluid vessel liner cmoprised of a compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other.
In accordance with another embodiment, a biological fluid vessel liner forming a sleeve comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, a tube being covered on all surfaces with polytetra-fluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be permanently bent away from a linear axis.
In accordance with another embodiment, apparatus for correcting narrowing of a fluid vessel of a biological body comprising a catheter, for insertion into the blood vessel at a location remote from a region of narrowing, a fluid vessel liner comprised of a radially resiliently compressible tube having an elongated split along one side thereof and the edges of the sides of the linear on each side of the split overlapping each other contained within the catheter adjacent a tip of the catheter in a compressed condition, means for expulsion of the liner from the catheter forward of the catheter at the region of narrowing, and means for facilitating expansion of the tube to a natural expanded condition thereby to support the blood vessel from the interior to the diameter of the tube in its naturally expanded diameter, in which the tube is formed of magnetically attractable metal, and in which the means for facilitating expansion is comprised of an electromagnet for containment within the tube, and for attracting and radially compressing the compressible tube thereto by means of a controllable electromagnetic field when the tube is contained within the catheter, and for releasing the compressible tube by liquidating the electromagnetic field when the compressible tube is in a deployment position at the region of narrowing, thus allowing the compressible tube to expand to a predetermined diameter.
In accordance with another embodiment, a method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter, in which the liner is formed of SS a longitudinally split tube of magnetic material having overlapping edges along the split, the contracting step being comprised of applying a magnetic field to the material to cause radial contraction and overlap of the overlapping edges additional to the overlap achieved in the absence of said field.
In accordance with another embodiment, a method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter in which the liner is comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, the tube being covered on all surfaces with polytetra-fluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be bent away from a linear axis.
- 2a -~' 03 While the description herein may appear to 04 be mainly directed to application to blood ves.sels, 05 the invention is not intended to be so limited. The 06 invention i8 equally applicable to all biological 07 ducts, including urological ducts.
08 A better understanding of the invention 09 will be obtained upon reading the description below, in conjunction with the following drawings, in which:
11 Figures 1-4 are isometric views of various 12 types of biological sleeves, as contemplated by the 13 present invention, 14 Figure 5 is an end view of a biological sleeve as contemplated in the present invention, 16 Figure 6 is a partly sectional view of the 17 end of a catheter containing the biological sleeve, 18 prior to deployment, 19 Figure 7 is a cross-sectional view along 20 section X-X of Figure 6, 21 Figure 8 is a partly sectional view of a 22 catheter in accordance with the present invention of a 23 type designed to retrieve an alrçady deployed sleeve, 24 and Figure 9 is a cross-section along section 26 Y-Y of Figure 8.
. 27 Turning now to Figures 1-5, a sleeve 1 28 formed of a cylinder of spring sheet stainless steel 29 coated with Teflon~ (polytetrafluoroethylene) is shown. The cylinder is axially slit, the edges along 31 the slit overlapping as shown at 2. It may be seen 32 that the sleeve can be radially compressed, and will 33 spring back. to a predetermined diameter, due to the 3~ . spring nature of the stainless steel. An outer side of the sleeve 10 can slip past an inner side of the 36 sleeve 9, during compression. In.the embodiment sho.wn 37 in Figure 1, the surfaces of the sleeve are smooth and 01 are not generally perforated.
02 The embodiment shown in Figure 2 cont-ains 03 circular corrugations 3. This allows the sleeve to be 04 bent permanently. Prior to deployment, however, the 05 sleeve is straightened against the spring tendency to '06 maintain it in the bent position. It will ,be 07 temporarily maintained in its straightened position 08 within the deployment catheter to be described below.
09 The embodiment shown in Figure 3 is formed of stainless steel mesh 5, which can be used in a 11 biological duct in which the maximum interior surface 12 area of the duct must be exposed. The embodiment of 13 Figure 4 is formed of stainless steel spring sheet 14 which has been punched with a large number of holes 7. This structure provides more strength than the 16 structure of Figure 3, but allows significant areas of 17 the inner surface of the biological duct to be exposed 18 to fluids passing therethrough. The embodiments of 19 Figures 3 and 4 can of course contain circular corrugations as in Figure 2, in order that the sleeve 21 can be permanently bent.
- 22 It should be noted that it is possible the 23 sleeves as shown in Figures 3 and 4 will "grow into"
24 (be incorporated into) the wall of the biological duct after some time, and will become an integral part of 26 the duct. This can be better accomplished by not 27 coating the outside of the sleeves with Teflon~.
28 Figure 6 illustrates a sleeve deployment 29 catheter. A cathete~ sleeve 13 contains a plunger head 14, contained at the end of a plunger rod 15.
31 The plun,ger rod can slide within the catheter sleeve 32 13 either by being coupled by a thread 16, the plunger 33 rod rotating within the catheter sleeve, or, if no 34 thread is used, by simple manual sliding manipulation.
A nose cone 17 at the front of the sleeve 36 over the plunger head terminates in a conical tip 18.
01 With additional reference to Figure 7, a 02 sleeve 1 of a type described with reference to Figures 03 1-5 is contained within the nose cone 17, behind the 04 conical tip, in its compressed state. The sleeve is 05 maintained in the compressed state by means of 06 electromagnets 19, which are symmetrically disposed 07 around the axis of the instrument within the sleeve 08 and are fixed to the front of the plunger head 14.
09 The electromagnets can extend over the length of the sleeve, or shorter magnets can be used if sufficient 11 total magnetic strength is used to maintain the sleeve 12 in its compressed condition. Wires 20, used to power 13 the electromagnetics, extend through the plunger head 14 14 and through the catheter, and are coupled to a power supply outside the body of the patient, via a 16 switch (not shown).
17 The conical tip is formed of an inert 18 material 21, and contains at its end adjacent the 19 sleeve 1 and electromagnets 19, a conical chamfer 22.
The end 23 of the plunger head 14 has a diameter of 21 the inner diameter of the nose cone 17 so that it 22 bears against the edge of sleeve 1, which bears 23 against the chamfer 22. A tube 20A extends the length 24 of the catheter. --In operation, the catheter containing the 26 sleeve which is compressed under the influence of the 27 magnetic field of magnets 19 is inserted into the 28 biological duct to be expanded. When near the site to 29 be expanded, dye is inserted into the outer end of tube 20A, and passes down the tube 20A to pass out of 31 the conical tip 18 into the biological duct, so that 32 the restricted area to be expanded can be viewed by 33 X-ray, and thus to ensure that the sleeve is pushed to 34 the correct location.
With the conical tip located just behind 36 the region of the biological duct to be expanded, the 37 plunger rod is moved forward, either by rotating it, 01 and thus thrusting it forward by mutual action of the 02 threading 16, or if threading is not used, by manual 03 movement of the plunger rod within the catheter sleeve 04 13.
05 This causes the plunger head 14 to push 06 the plunger end 23 against the sleeve 1. The sleeve 1 07 and magnets 19, are forced against the inner portion 08 of the conical tip 18. Due to force against the 09 conical chamfer 22, the conical tip 18, which is split in its length at, for example, three locations 120 11 apart, and causes the conical tip 18 to open, hinged 12 at the ends of the chamfer by the resilient plastic 13 material of the conical tip. The sleeve 1, maintained 14 in its compressed position by the electromagnetic field of the electromagnets 19, is pushed out of the 16 catheter, forward of conical tip 18, with its outer 17 surface finally adjacent the inner surface of the 18 biological duct at the location where the biological 19 duct is to be expanded.
The electric current to the 21 electromagnets is then turned off, by opening of the 22 external switch described earlier. With the 23 electromagnetic field thus switched off, the force 24 maintaining the sleeve compressed is removed, and the sleeve expands to its predetermined diameter, under 26 spring tension. The plunger 14 is withdrawn back into 27 the nose cone 17, with the electromagnets fixed to the 28 conical head 23 following. The conical chamfer 22, 29 bearing on the electromagnets allow the jaws of the nose cone to resiliently close toward each other 31 following passage of the electromagnets 19 into the 32 nose cone, allowing the conical tip 18 to close. The 33 jaws of conical tip 18 can be an inert resilient 34 plastics material coupled via integral plastics spring to the remainder of nose cone 17, in a well known 36 manner.
37 With the electromagnets 19 safely - . . 203Q196-01 contained within the catheter, and the nose cone 18 02 closed, the catheter is withdrawn. The sleeve 1, 03 being expanded, both compresses any cholesterol that 04 may be present along the duct wall, and expands the 05 - interior of the biological duct, maintaining it in its 06 expanded condition.
07 In the event the sleeve is to be placed in 08 a biological duct at the location of a bend, the 09 sleeve shown in Figure 2 is used. While it is permanently bent so as to maintain the bent condition 11 under spring loaded tension as described above once 12 deployed, it is resiliently bent into a straight 13 cylindrical form against the spring tension prior to 14 being inserted into the catheter. After deployment and release of the electromagnetic field, the sleeve 16 can assume its permanently bent orientation.
17 Figures 8 and 9 illustrate a catheter for 18 retrieving a sleeve already in position. Illustrated 19 in Figure 8 is a biological duct 25 containing a sleeve 1 that has been previously deployed. While a 21 form of the catheter shown in Figure 6 could be used 22 for retrieval, a modified form of it is preferred to 23 be used as the retrieving catheter, as shown in Figure 24 8.
The catheter is inserted into the 26 biological duct, and to a position just adjacent the 27 front of sleeve 1. A plunger head 14 has attached to 28 the front thereof a set of electromagnets 19 as 29 described earlier. In this embodiment, however, a dye tube is not necessary. In addition, the interior of 31 nose cone 17 contains inwardly directed sloping edges 32 26 to form cam surfaces. The forward end 27 of 33 electromagnets 19 can be smoothly conical in shape.
34 In operation, the plunger head 14 is moved forward, pushing the electromagnets 19 forward. The 36 forward end of the electromagnets come into contact 37 with the sloping edges 26 of the interior of the nose - 2û30196 01 cone 17, forcing the jaws of the~nose cone open. The 02 electromagnets are pushed forward into the interior of 03 the sleeve 1. Due to the opacity of the sleeve 1 and 04 the catheter, the positioning can be seen clearly by 05 X-ray. However in case dye is to be injected, the 06 structure can contain an interior tube 20A as 07 described earlier with respect to Figure 6.
08 Once the electromagnets 19 are in 09 position, with the end of the plunger head against the adjacent end of sleeve 1, the external switch is 11 closed and electric current is applied to the 12 electromagnets 19. The sleeve 1 is attracted to the 13 electromagnet, and compresses by the outer side of the 14 sleeve 10 sliding over the inner side of the sleeve 9 (Figure 5). The sleeve 1 thus is wrapped around the 16 electromagnets 19 in a compressed state, and is 17 magnetically adhered thereto.
18 The plunger rod is then withdrawn, drawing 19 the plunger head, electromagnets and sleeve into the nose cone 17. As the outer edge of sleeve 1 and the 21 forward end 27 of the electromagnets pass the sloping 22 edges 26 of the interior of the conical tip 18, the 23 jaws of the conical tip close. The sleeve is thus 24 safely contained within the catheter. The catheter is then withdrawn from the biological duct with the 26 sleeve.
27 It is preferred that three identical 28 electromagnets 19 symmetrically located about the axis 29 of the catheter should be used, preferably insulated from each other by means of inert resilient insulation 31 28. The wires 20 can pass through the insulation 28 32 parallel to the axis of the catheter in order to 33 connect to electromagnetic field generating coils 34 forming part of the electromagnets 19. In addition, a center core 29 of the electromagnets can be filled 36 with inert resilient material, such as silicone 37 rubber, and may contain the wires~.
.
01 It should be noted that the catheter 02 sleeve can be used to insert an ultrasonic transducer, 03 such as a miniature quartz crystal, into the 04 biological duct, in place of the conical tip. Wires 05 for operating the transducer can be passed through the 06 catheter to imaging electronics outside the body. The 07 head can be used for imaging the interior of the duct, , 08 and surrounding structures.
09 A person skilled in the art understanding the present invention may now conceive of variations 11 o,r other embodiments using the concepts described 12 herein, such as other means for compressing the 13 sleeve. All are considered to be within the sphere 14 and scope of the invention as defined in the claims appended hereto.
Claims (8)
1. A biological fluid vessel liner forming a sleeve comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, a tube being covered on all surfaces with polytetrafluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be permanently bent away from a linear axis.
2. Apparatus for correcting narrowing of a fluid vessel of a biological body comprising a catheter, for insertion into the blood vessel at a location remote from a region of narrowing, a fluid vessel liner comprised of a radially resiliently compressible tube having an elongated split along one side thereof and the edges of the sides of the linear on each side of the split overlapping each other contained within the catheter adjacent a tip of the catheter in a compressed condition, means for expulsion of the liner from the catheter forward of the catheter at the region of narrowing, and means for facilitating expansion of the tube to a natural expanded condition thereby to support the blood vessel from the interior to the diameter of the tube in its naturally expanded diameter, in which the tube is formed of magnetically attractable metal, and in which the means for facilitating expansion is comprised of an electromagnet for containment within the tube, and for attracting and radially compressing the compressible tube thereto by means of a controllable electromagnetic field when the tube is contained within the catheter, and for releasing the compressible tube by liquidating the electromagnetic field when the compressible tube is in a deployment position at the region of narrowing, thus allowing the compressible tube to expand to a predetermined diameter.
3. Apparatus as defined in claim 2, the catheter further comprising an axially split nose cone having a plurality of jaws resiliently biased to a closed position, located immediately ahead of the compressible tube when contained within the catheter, the interior of the nose cone containing a conical chamfer immediately adjacent the compressible tube, whereby when the compressible tube is pushed forward to facilitate expulsion, the compressible tube rides against the conical chamfer, forcing open the jaws of the nose cone.
4. Apparatus as defined in claim 3, further including an axial tube extending substantially the length of the catheter, for carrying dye to the front of the nose cone.
5. Apparatus as defined in claim 2 in which the electromagnet is formed of three similar segments located 120° apart symmetrically about the axis of the catheter, separated by a resilient insulator means, wires for the electromagnet segments passing along or parallel to the axis of the catheter to the exterior of the catheter for connection to control apparatus.
6. A method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter, in which the liner is formed of a longitudinally split tube of magnetic material having overlapping edges along the split, the contracting step being comprised of applying a magnetic field to the material to cause radial contraction and overlap of the overlapping edges additional to the overlap achieved in the absence of said field.
7. A method as defined in claim 6, in which the step of applying a magnetic field is comprised of inserting an electromagnetic axially within the liner, and applying electric current to the electromagnet.
8. A method for expansion of a biological fluid vessel, comprising radially contracting a radially resiliently compressible liner, inserting the liner to a position in said vessel, and allowing the liner to expand to a predetermined diameter in which the liner is comprised of a radially compressible tube having an elongated split along one side thereof, the sides of the tube on each side of the split overlapping each other, the tube being covered on all surfaces with polytetrafluoroethylene, the cross-section of the tube being circular, the tube containing annular corrugations therein over a predetermined length, for providing a region allowing the tube to be bent away from a linear axis.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US443,002 | 1989-11-29 | ||
| US07/443,002 US5089006A (en) | 1989-11-29 | 1989-11-29 | Biological duct liner and installation catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2030196A1 CA2030196A1 (en) | 1991-05-30 |
| CA2030196C true CA2030196C (en) | 1997-07-22 |
Family
ID=23759042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002030196A Expired - Fee Related CA2030196C (en) | 1989-11-29 | 1990-11-16 | Biological duct liner and installation catheter |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US5089006A (en) |
| CA (1) | CA2030196C (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2030196A1 (en) | 1991-05-30 |
| US5089006A (en) | 1992-02-18 |
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| MKLA | Lapsed |