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WO1990012611A1 - Dispositif d'acces pour perfusion non intravasculaire - Google Patents

Dispositif d'acces pour perfusion non intravasculaire Download PDF

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Publication number
WO1990012611A1
WO1990012611A1 PCT/US1990/002173 US9002173W WO9012611A1 WO 1990012611 A1 WO1990012611 A1 WO 1990012611A1 US 9002173 W US9002173 W US 9002173W WO 9012611 A1 WO9012611 A1 WO 9012611A1
Authority
WO
WIPO (PCT)
Prior art keywords
infusion
access device
porous membrane
intravascular
therapeutic agent
Prior art date
Application number
PCT/US1990/002173
Other languages
English (en)
Inventor
Stephen R. Ash
Elsa M. Janle
Original Assignee
Ash Medical Systems, 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 Ash Medical Systems, Inc. filed Critical Ash Medical Systems, Inc.
Publication of WO1990012611A1 publication Critical patent/WO1990012611A1/fr

Links

Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0293—Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube

Definitions

  • the present invention relates generally to the field of medical devices and methods and, more particularly, to a device and method for infusion of therapeutic agents into the body.
  • Type II diabetes Insulin Independent Diabetes
  • About 80% of the diabetics are Type II and about 20% are Type I. All of the Type I diabetics require insulin treatment and many of the Type II patients also require insulin.
  • the primary advantage in using such pumps for insulin administration is that insulin can be delivered at a slow, basal rate, continuously and at a higher rate after food consumption. This pattern of insulin administration mimics more closely the normal secretion pattern of the human pancreas than does the insulin absorption from injected insulin.
  • Another advantage is that the rate can be varied to meet changing demands and unplanned events, such as a change in meal time or size, can be compensated for easily. To even begin to approach the insulin patterns achievable by insulin infusion pumps using injections requires at least 4 injections per day.
  • Bolus administration of drugs with a low therapeutic index may expose patients to transient toxic levels of a drug to maintain the necessary effective lower level.
  • Availability of a more permanent access device provides the option of infusing a greater variety of drugs to maintain constant low effective Concentration while minimizing the exposure of the patient to toxic levels of a particular drug. Examples of these types of drugs for which this feature would be useful include chemotherapy agents used to treat cancer and immunosuppressive drugs used to prevent post-transplant tissue rejection.
  • a continuous insulin infusion pump contains an insulin reservoir which is connected to a long tube having a needle at the opposite end.
  • the needle is inserted into the subcutaneous tissue, usually the abdomen, and taped in place.
  • the subcutaneous access method There are several problems associated with this method, which is generally known as the subcutaneous access method.
  • the mere presence of the needle can be painful. Any bumps or abrasions to the area of the needle insertion cause additional pain.
  • the needle is secured in place only by tape, there is the possibility that it will become dislodged without the patient even being aware of the dislodgment. This can result in the patient not receiving the needed medication. For diabetics whose insulin is not being administered, such an occurrance can lead to ketoacidosis and coma.
  • a catheter like device consisting of a short plastic tube having a needle stylus inside can be employed.
  • the catheter/needle combination is inserted into the tissue and the needle removed, thereby leaving the catheter in place.
  • infusion pumps In addition to external mounted infusion pumps, there are also permanently implantable infusion pumps. Characteristically, such pumps contain reservoirs for insulin which must be filled periodically from outside the body by injecting insulin into the reservoir through a septum which is placed near the skin surface. So far, these devices have been used only on an experimental basis. There are at least several potential disadvantages in an infusion system of this type. For example, in the case of a *> _ * malfunction, major surgery would be required to remove the pum * ,” There is -also the risk of a malfunction of the type . which . * f * * f Ould ⁇ cause a "run away pump.” As opposed to an ** _.
  • a non-intravasculer infusion access device for long term ⁇ 0 continuous infusion of drugs includes a porous membrane made of a material whjch is biocompatible for long term patency inside the body.
  • the porous membrane is connected to a conducting tubing-which exits from the body and is connected to a drug 25 fc infusfon system.
  • a cuff of porous material which serves to anchor the access device in position when tissue ingrowth into the cuff has occurred.
  • the present invention also comprises a method for continuous long term infusion of a drug into a non-imtravascular access site.
  • FIG. 1 is an elevation view of the infusion access device of the present invention.
  • FIGS. 2-6 depict successive steps in the implantation of the infusion access device of the present invention in a subcutaneous body location.
  • FIG. 7 is a graph of test results showing the insulin dosage and glucose response for a test dog being administered insulin by the conventional subcutaneous injection method.
  • FIG. 8 is a graph of test results showing the insulin dosage and glucose response for the same test dog used to obtain the results shown in FIG. 7 using the infusion access device of the present invention to provide continuous insulin infusion.
  • the device 10 is specifically designed to administer the infusion of insulin into a subcutaneous body location. Nevertheless, it will be appreciated by those skilled in the art that the device 10 can be modified to permit the infusion of other types of therapeutic agents and to permit access to other non-intravascular body locations.
  • a generally tubular shaped porous membrane 11 At the distal end of the device 10 is a generally tubular shaped porous membrane 11.
  • the porous membrane 11 acts as a filter to allow free flow of the drug molecules being infused therethrough, in this case insulin, while preventing larger bacteria or viruses from entering the body.
  • Membrane 11 also serves to significantly increase the surface area over which the drug is infused into and absorbed by the body.
  • the membrane 11 is formed of a copolymer of polyacrylonitrile and polyvinyl chloride manufactured by .R. Grace, Lexington, Mass.
  • the pore size of membrane 11 may be increased or decreased, or its filtering characteristics otherwise changed, depending upon the type of drug or drugs being infused. This may be accomplished in a variety of ways known to those skilled in the art, such as by changing the membrane material composition, thickness, etc. Since in all cases it will be desirable to limit the risk of infection or disease being carried into the body through the device, the pore size of the membrane should minimally have a cutoff no greater than about .2 to 1 micron. At the lower end of this range, i.e. about .2 microns, the passage of all bacteria and most types of viruses will be restricted, while a 1 micron cutoff will at least restrict the passage of bacteria.
  • tubular porous membrane 11 is inserted over an end of a length of flexible conducting tubing 12 and fixed thereto by a suitable biocompatible adhesive such as Dymax medical grade ultraviolet curing adhesive.
  • the conducting tubing 12 is adapted to extend externally of the body with the porous membrane 11 implanted subcutaneously.
  • a cuff 13 At the junction of the membrane and the conducting tubing is a cuff 13. The purpose of cuff 13 is to allow tissue ingrowth into the cuff and seal off any path for passage of skin bacteria around the device, and also to serve as an anchoring means to anchor the device in the body after sutures are removed.
  • Cuff 13 is preferably made of expanded polytetrafluoroethylene, although other porous materials which promote ingrowth of fibroblast and fibrous tissue, such as Dacron or textured polyurethane may also be employed.
  • cuff 13 is secured to conducting tubing 12 by a suitable adhesive.
  • the conducting tubing 12 has a •Q ' 25" ⁇ 0 _B_.35 cm) inside diameter and .040" (0.1016 cm) outside diameter.
  • other materials may alternatively be used for the conducting tubing 12, it has 5 _ been found that polyurethane tubing bonds well to the expanded polytetrafluoroethylene cuff 13 and membrane 12 while also possessing good biocompatibility and flexibility characteristics.
  • Suture retainers 15 and 16 are. axially aligned along the length of the tubing 12 and are spaced approximately 1/8 inch (0.318 cm) apart.
  • the suture retainers 15 and 16 are formed from droplets of Dymax medical grade ultraviolet curing adhesive.
  • an adapter 17 which serves to permit connection and
  • the adapter 17 is formed of a_,length of small gauge tubing made from steel or other suitably rigid metal.
  • the • -device 10 can also be used with implantable infusion pumps.
  • the pump 19 may be a conventionally known pump, such as for - example a CPI Betatron II insulin infusion pump manufactured by CPI/Liliy located in St. Paul, Minnesota.
  • the tissue in the area of the body entrance site 20 is anesthetized with a 1'ocal anesthetic.
  • the subcutaneous infusion access device 10 including the porous membrane 11 is placed inside the lumen of an introducer 21 in the form of a rigid hollow needle.
  • the hollow needle introducer is a 13 gauge size and made of stainless steel.
  • the device 10 and introducer 21 can be conveniently provided to the physician in a sterile, prepackaged kit intended for one time use.
  • a small stab incision is made in the anesthetized skin.
  • the introducer 21 is inserted through the incision (FIG. 2) and advanced sufficiently beneath the skin so that the membrane 11 will be totally implanted within the subcutaneous area when the introducer is withdrawn (FIG. 3).
  • the introducer is then withdrawn (FIG. 4) while the device 10 is held in place, leaving the membrane 11 under the skin.
  • a skin suture "A” is made around the device at the entrance site, closing the incision.
  • Another suture "B” is then placed around the device between the suture retainers 15 and 16 (FIG. 5). This additional suture serves to further stabilize the device and prevent accidental withdrawal from the body.
  • Both of the sutures can be removed after the position of the device 10 is stabilized in the body by fibrous tissue ingrowth into the cuff 13. Once the patency of the device 10 is confirmed, infusion of insulin from container 22 into the body can be started by activation of infusion pump 23 (FIG. 6).
  • FIG. 6 diagrammatically shows placement of the device 10 in the subcutaneous tissue of the abdomen. Other possible locations for insulin administration are the peritoneal cavity or an intramuscular location.
  • FIGS. 7 and 8 The results of a comparison study between the device 10 of the present invention and conventional injection administration is illustrated in FIGS. 7 and 8.
  • the results graphed in FIG. 7 were obtained in a subject test dog by administering insulin injections of Regular and NPH insulins two times per day.
  • the total daily insulin dosage administered by such injections was 18 units.
  • the FIG. 7 graph depicts the change in blood glucose levels over time, with the "+" representing average daily blood glucose levels (mg/dl) and the square symbol indicating the amount of insulin (uU/ml) administered each day.
  • FIG. 7 shows, the average daily glucose levels of the test dog fluctuated greatly and were frequently above the desired maximum 250 mg/dl level.
  • the graph of FIG. 8 shows the insulin infusion and glucose levels for the same test dog, brut wherein insulin was received solely by infusion through the infusion access device of the present invention.
  • insulin was infused into the test dog at a constant basal insulin infusion rate on a continuous "around the clock” basis supplemented by bolus doses-of insulin given with meals.
  • the "+" represents average daily blood glucose levels (mg/dl) and the square symbols indicate the amount of insulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé et un dispositif d'accès (10) pour perfusion non intravasculaire de manière continue et à long terme de médicaments. Le dispositif d'accès de perfusion (10) comprend une membrane poreuse (11) constituée en un matériau qui est biocompatible pour rester dans un état ouvert à long terme à l'intérieur du corps. La membrane poreuse (11) est connecté à un tubage conducteur (12) qui sort du corps et est connecté à un système de perfusion de médicaments. Au niveau de la sortie, une manche (13) en matière poreuse est prévue. La manche (13) sert à ancrer le dispositif d'accès (10) et le positionner, les tissus environnants du corps se développant autour de la manche. Sont également prévus deux petits dispositifs de retenue de suture (15, 16) pour stabiliser la disposition du dispositif d'accès (10) jusqu'à ce que les tissus se développent dans la manche (13) et autour de celle-ci.
PCT/US1990/002173 1989-04-21 1990-04-20 Dispositif d'acces pour perfusion non intravasculaire WO1990012611A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US34136489A 1989-04-21 1989-04-21
US341,364 1989-04-21

Publications (1)

Publication Number Publication Date
WO1990012611A1 true WO1990012611A1 (fr) 1990-11-01

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996033761A1 (fr) * 1995-04-28 1996-10-31 Medtronic, Inc. Systeme de catheter pour perfusion intraparenchymateuse
EP0761198A1 (fr) * 1995-09-12 1997-03-12 Fresenius AG Cathéter pour l'alimentation entérale par voie percutanée
EP0724408A4 (fr) * 1993-10-18 1997-10-01 Inner Ear Medical Delivery Sys Systeme multifonctionnel de diagnostics et de traitements de l'oreille interne
EP1393770A1 (fr) * 2002-08-29 2004-03-03 REHAU AG + Co Article médical
US7547302B2 (en) 1999-07-19 2009-06-16 I-Flow Corporation Anti-microbial catheter
RU2366465C2 (ru) * 2003-05-12 2009-09-10 Ай-Флоу Корпорейшн Катетер для равномерной подачи лекарственного средства

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4209014A (en) * 1977-12-12 1980-06-24 Canadian Patents And Development Limited Dispensing device for medicaments
US4351333A (en) * 1975-10-28 1982-09-28 Harrison Lazarus Peritoneal fluid treatment apparatus, package and method
JPS5885161A (ja) * 1981-11-16 1983-05-21 Nikkiso Co Ltd 濾液採取管
US4402694A (en) * 1981-07-16 1983-09-06 Biotek, Inc. Body cavity access device containing a hormone source
US4605399A (en) * 1984-12-04 1986-08-12 Complex, Inc. Transdermal infusion device
US4650473A (en) * 1985-04-15 1987-03-17 Warner-Lambert Company Suturing saddle
US4711251A (en) * 1980-09-02 1987-12-08 Medtronic, Inc. Body implantable lead
US4726381A (en) * 1986-06-04 1988-02-23 Solutech, Inc. Dialysis system and method
US4753636A (en) * 1983-08-02 1988-06-28 Endocon, Inc. Subcutaneous implant kit
US4798207A (en) * 1983-05-09 1989-01-17 Wade Stephen E Device for enabling time-integrated measurement of substances in biological fluids
US4904260A (en) * 1987-08-20 1990-02-27 Cedar Surgical, Inc. Prosthetic disc containing therapeutic material
US4923457A (en) * 1985-11-22 1990-05-08 Industrikontakt Ing. O. Ellingsen & Co. Artificial gland for implantation in a human body

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4351333A (en) * 1975-10-28 1982-09-28 Harrison Lazarus Peritoneal fluid treatment apparatus, package and method
US4209014A (en) * 1977-12-12 1980-06-24 Canadian Patents And Development Limited Dispensing device for medicaments
US4711251A (en) * 1980-09-02 1987-12-08 Medtronic, Inc. Body implantable lead
US4711251B1 (en) * 1980-09-02 1994-06-28 Medtronic Inc Body implantable lead
US4402694A (en) * 1981-07-16 1983-09-06 Biotek, Inc. Body cavity access device containing a hormone source
JPS5885161A (ja) * 1981-11-16 1983-05-21 Nikkiso Co Ltd 濾液採取管
US4798207A (en) * 1983-05-09 1989-01-17 Wade Stephen E Device for enabling time-integrated measurement of substances in biological fluids
US4753636A (en) * 1983-08-02 1988-06-28 Endocon, Inc. Subcutaneous implant kit
US4605399A (en) * 1984-12-04 1986-08-12 Complex, Inc. Transdermal infusion device
US4650473A (en) * 1985-04-15 1987-03-17 Warner-Lambert Company Suturing saddle
US4923457A (en) * 1985-11-22 1990-05-08 Industrikontakt Ing. O. Ellingsen & Co. Artificial gland for implantation in a human body
US4726381A (en) * 1986-06-04 1988-02-23 Solutech, Inc. Dialysis system and method
US4904260A (en) * 1987-08-20 1990-02-27 Cedar Surgical, Inc. Prosthetic disc containing therapeutic material

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0724408A4 (fr) * 1993-10-18 1997-10-01 Inner Ear Medical Delivery Sys Systeme multifonctionnel de diagnostics et de traitements de l'oreille interne
WO1996033761A1 (fr) * 1995-04-28 1996-10-31 Medtronic, Inc. Systeme de catheter pour perfusion intraparenchymateuse
EP0761198A1 (fr) * 1995-09-12 1997-03-12 Fresenius AG Cathéter pour l'alimentation entérale par voie percutanée
US7547302B2 (en) 1999-07-19 2009-06-16 I-Flow Corporation Anti-microbial catheter
US8343135B2 (en) 1999-07-19 2013-01-01 Kimberly-Clark Worldwide, Inc. Anti-microbial catheter
EP1393770A1 (fr) * 2002-08-29 2004-03-03 REHAU AG + Co Article médical
RU2366465C2 (ru) * 2003-05-12 2009-09-10 Ай-Флоу Корпорейшн Катетер для равномерной подачи лекарственного средства

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