CA1209754A - Helical ureteral stent - Google Patents

Helical ureteral stent

Info

Publication number
CA1209754A
CA1209754A CA000442502A CA442502A CA1209754A CA 1209754 A CA1209754 A CA 1209754A CA 000442502 A CA000442502 A CA 000442502A CA 442502 A CA442502 A CA 442502A CA 1209754 A CA1209754 A CA 1209754A
Authority
CA
Canada
Prior art keywords
stent
coils
proximal end
ureteral stent
tubular member
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
Application number
CA000442502A
Other languages
French (fr)
Inventor
William J. Norton
Irwin S. Wolosky
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CR Bard Inc
Original Assignee
CR Bard Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CR Bard Inc filed Critical CR Bard Inc
Application granted granted Critical
Publication of CA1209754A publication Critical patent/CA1209754A/en
Expired legal-status Critical Current

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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/048—Ureters
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Abstract

ABSTRACT OF THE DISCLOSURE

A ureteral stent for maintaining drainage of urine between the kidney and the bladder including an elongated flexible silicone tubular member having series of helical coils on its distal end, the longitudinal axis of which is parallel to the tubular member. A retention coil is formed on the proximal end of the tubular member for reception in the renal pelvis and drainage holes are formed along the length of the stent. The stent is straightened for insertion by means of a wire guide.

Description

:L

The general ield of this in~ention is directed to the art of urology for achieving and maintaining internal ureteral drainage in a variety o pathologic conditions.
Frequently, intubation of a ureteral stent is necessary with patients having malignant diseases, progressive azotemia and ureteral obstructions. Such obstructions are frequently caused by carcinoma of the prostate, bladder, cervix, uterus, ovary and rectosigmoid. Generally such stents are utilized on a temporary basis and are only left indwelling until a surgical procedure can be performed.
~ Some stents on the other hand may be utilized as a ; permanent method of diversion and often for palliation and relief of pain.
The use of stenting catheters has been substantia-ted in the medical literature and in general practice, Note for examplel Gibbons, R. F.; Correaa, R. J., Jr.; Cummings, K.
B., and Mason, J. To " EXPERIENCE WITH INDWELLIN~ URETE~AL
STENT CATHETERS" Journal of Uroloyy, 197~ 115:22; and Hepper-ten, Thomas W., M . D .: " SELF-RETAINED INTER~AL
URETERAL ST~NTS~ A NEW ARPROACH", The Journal of Urology, June, 1978, 119:731-734.
Indwelling ureteral ~tents also aid ureteral alignment and maintenanc0 of ureteral caliber. The devices can be placed either endascopically or utiliz-ing open surgery to ., ~ , ,. ~, -: ~`' provide drainage of the kidney to the bladder when the ana-tomical ureter cannot adequately perform this task by itself.
Ureteral stents are shown in the prior art and emphasis in recent years has been directed to providing means associated with the stents to prevent upward or downward migration. Note, for example, U.S. Patent 3,938,529 (Gibbons), which utilizes flexible, laterally ex-tending barbs for this purpose. Barbs of this type, however, in-crease the diameter of the stent and make it more difficult to insert and in some instances can cause the stent to migrate outside the bladder creating problems for the physi-cian. U.S. Patent 4,212,304 (Finney), provides a ureteral stent having opposed hook-shaped elements for retention.
Devices of this type must be provided in numerous lengths to accommodate the particular patient. Additionally, note the ureteral prosthesis of U.S. Pa-tent 4,225,979 (Rey et al).
It is an object of our invention to pxovide a new ureteral stent having a novel retention means on at least one end thereof.
Another object of the invention is to provide a novel helical ureteral stent that is simple to insert and need only be provided in a single length to eliminate the need for radiographic sizing.
Another ohject of our invention is the provision of a new coil stent which is relatively inexpensive, safe and ef~icient in use and which may be inserted utilizing conven-tional techniques.
We have therefore provided a new helical coil s-tent which is simple in construction, relatively easy to insert cystoscopically and is safe for use by the patien-t. Addi-tionally, the unique design Oe our new helical coil st2n-t provides an effective means for preventing upward or downward migration of the device and yet provides a non~traumatic spring effect when the patient is active.
Accordingly the invention provides an adjustable l~ngth ureteral sten-t for maintaining drainage be-tween the kidney and bladder including an elongated flexihle tubular ,t, ~
r~
~j3~`

"` ~l2~75~

member provided with drainage means extending along the length thereof, retention means on the proximal end of the tubular member adapted -to be received in the kidney, a plurality of helical coils formed on the distal end of the tubular member, at least one of which is adapted in use ~o remain in the bladder, the remaining coils being adapted to straighten out as an extension of the tubular member to provide length adjustment to accommodate said stent to different patient sizes, the central axis of -the helix of the coils being substantially parallel to the portion of the tubular body between the coils and the proximal end reten-tion means.
The new stent need only be provided in one length for each French size (diameter). It is the helical coil configuration on the distal or bladder end of the s-tent which makes the single size feature possible and eliminates the necessity for radiographic sizing prior to insertion and the inconvenience of inadvertently placing a stent that may either be too long or too short as is prevalent with the prior art devices.
Embodiments of the invention will now be descrlbed, by way of example, with reference to the accompanying draw-ings, in which:
FIGURE l is a schematic isometric view illustrating a ureteral sten~ in position between the kidney and the bladder;
FIGURE 2 is a front elevation of the new ureteral stent and also including the means used for inserting the same;
FIGURE 3 is an end view taken from the left of Figure 2 o~ the stent only;
FIGURE 4 is an eleva-tion of a first modified form of the ureteral stent;

:4 FIGURE 5 is an eleva~ion of.a second modi-~ied.form of ureteral stent; and FIGURE 6 is an eleva:tion of a further modi-fied form of s-tent having a hook-shaped retaining means.

S The new ureteral sten-t.is shown generally in FigurP 1 at 10. It is depicted in place within the afEected ure-ter 11 which connects between the renal pelvis 12 and the bladder 13. ~or the purpose of further description, and utilizing conventional medical terminology, the end of the stent received in the kidney will be designated as the proximal end and the opposite end of the stent received in the bladder will be termed the distal end.
While the stent may be formed of any bio-compatible material, a soft, flexible, medical grade silicone plastic is preferred. This material resists tissue adherence and encrustation~ The material is also chosen to be radio-opaque in order to facilitate insertion. The stent may be formed with di:Eferent outside diameters, as for example French sizes 6, 7 and 8, however it is only necessary to provide a single l~ngth for all uses and a length oE 31 centimeters has been found ideal :Eor this purpose. In the preferred form oE the invention shown in Figure 2, the proximal end of the stent is provided with a rela-tively short helical coil configuration 14,:shown for example as having only one-and a half.revolutions. ~t.the distal end, the.stent is~set with:a longer coil 15 which in the emdodi~
ment:shown represent five coils. It will be seen that the ` ~ 7~

longitudinal axis of the he:Lical construction is parallel to the main body 16 of the stent but offset therefrom in the preferred embodiment.
Drainage holes 17 are provided throughout the entire length of the helical coil ,tent leading -to the-lumen, although there is a greater concentration of the drainage holes at the proximal end. When the stent is formed, both ends may be closed off, although it will be seen later herein that during insertion the distal end is clipped off to permit use of the spring wire guide and push catheter.
The spring wire guide used :for insertion is shown in Figure 2 at 18 and the plastic push catheter at 19.
In the modified form of stent shown in Figure 4, it will be noted that the coils are formed with the helical axis concentric with the ma.in tubular body 20 of the stent.
The Figure 5 embodimerlt is basically the same as the preferred embodiment, however here the proximal end coils are formed with a constant :radius wherein the preferred form is spiraled.
The form of the invent.ion shown in Figure 6 utilizes the coaxial coil arrangement of Figure 4 on the distal end, however the proximal end is ormed with a "J hook" 21 instead of the helical coil.
It will be appreciated that with each of the designs, the retention coils or hook'forms provi~e an effective means for preventing bo-th'upward or downward migration of the stent yet the cons.truction is soft and pliable and provides ' a nontraumatic ~'spring effect" especially ~uring times when the patient is active.

,~;

5~;
I' .
The technique for selection and insertion o~ our new ureteral stent is conventional. The surgeon selects the proper French size, as one would normal'ly do with any ureteral catheter. The stent of the present inVRntiOn is designed to accommodate ureteral lengths of from 11 centimeters to 30 cRntimeters. 'At fuIl extension of the stent, at least one coil on the distal end of the stent must remain in the bladder to prevent'upward migration.
When placing the stent using endoscopic means, the distal end is clipped off as noted previously. The spring wire guide 18 is inserted through the clipped end of the stent lumen and the stent is threaded over the wire. This serves to straighten the retention coils of the helix. Care must be taken not to force the wire guide through the proximal end of the stentO Subsequently, the plastic push catheter is slipped on next and this serves to hold the stent in position when the wire guide is withdrawn from the stent after insertion and placement.
The assembly is inserted as a conventional ureteral catheter. Once the renal pelvis has been ~entered, confirmation can be obtained by a radiograph~ Thereafter the spring wire guide is gent'ly withdrawn while holding the plastic push catheter in position. After the wire guide 18 and the push catheter 19 have been complete'ly withdrawn, the stent is left in place and any excess stent coils in ~he bladder may be clipped and removed endoscopically if desired. The surgeon must insure, h'owever, ~hat at least one retention coil'is'left in the bladder for the purpose of precluding upward migration of the stent.

. .

7~i~
'I
Our new stent may also be inserted in-to the ureter during open surgery. In th:is application, the distal end tip is not clipped off and the plastic push catheter 19 is not necessary. The spring ~ire guide 18/ however, is inserted into the stent via one of the side drainage holes 17. The coil is straightened and the stent is advanced into the ureter via a surgical incision. If the bladder end is inserted first, the physician can determine when the stent is in the bladder by aspirating urine with syringe suction on the stent at the drainage hole closest to the ureteral entry point. Placement of the stent into the renal pelvis is accomplished by using the same technique. Whether or not the stent is removed is of course left to the discretion of the physician. Our stent may be removed endoscopically utilizing forceps.
Various modifications can be made in the constructions noted above without departing from the invention as claimed.
For example, if desired, means for increasing the rigidity of the proximal and distal coils may be incorporated. To this extent, fabric, metal or plastic materials may be incorpora-ted into the coils ior the purpose oE making them more rigid and therefore more resistant to migration. Further, measurement markings or indexes may be painted or otherwise applied -to the stent which would be visible during X ray.

Claims (7)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An adjustable length ureteral stent for maintain-ing drainage between the kidney and bladder including an elongated flexible tubular member provided with drainage means extending along the length thereof, retention means on the proximal end of the tubular member adapted to be received in the kidney, a plurality of helical coils formed on the distal end of the tubular member r at least one of which is adapted in use to remain in the bladder, the remaining coils being adapted to straighten out as an exten-sion of the tubular member to provide length adjustment to accommodate said stent to different patient sizes, the central axis of the helix of the coils being substantially parallel to the portion of the tubular body between the coils and the proximal end retention means.
2. A ureteral stent as defined in claim 1 wherein the tubular member has an internal lumen and the drainage means consists of a plurality of holes extending into the lumen.
3. A ureteral stent as defined in claim 2 wherein the drainage holes extend along the entire stent with a greater concentration thereof adjacent the proximal end thereof.
4. A ureteral stent as defined in claim 1, wherein the retention means on the proximal end consists of at least one helical coil substantially coaxial with said first coils.
5. A ureteral stent as defined in claim 4, wherein the axis of the helix of the coils is offset from the portion of the tubular body between the coils and the proximal end retention means.
6. A ureteral stent as defined in claim 4, wherein the axis of the helix of the coils is coaxial with the portion of the tubular body between the coils and the proximal end retention means.
7. A ureteral stent as defined in claim 1, wherein the retention means comprises a hook formation extending less than 360°.
CA000442502A 1982-12-07 1983-12-02 Helical ureteral stent Expired CA1209754A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US447,679 1982-12-07
US06/447,679 US4531933A (en) 1982-12-07 1982-12-07 Helical ureteral stent

Publications (1)

Publication Number Publication Date
CA1209754A true CA1209754A (en) 1986-08-19

Family

ID=23777301

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000442502A Expired CA1209754A (en) 1982-12-07 1983-12-02 Helical ureteral stent

Country Status (12)

Country Link
US (1) US4531933A (en)
JP (1) JPS59111748A (en)
AT (1) AT391625B (en)
AU (1) AU563743B2 (en)
CA (1) CA1209754A (en)
CH (1) CH662513A5 (en)
DE (1) DE3342163A1 (en)
DK (1) DK559383A (en)
FR (1) FR2537001B1 (en)
GB (1) GB2132091B (en)
NO (1) NO155913C (en)
SE (1) SE454050B (en)

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