# US 6,471,688 B1 · Osmotic pump drug delivery systems and methods

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- Number: US 6,471,688 B1
- Document ID: US6471688B1
- Status: Granted
- Kind: B1
- Application number: 09/503,821
- Filed: 2000-02-15
- Granted: 2002-10-29
- Earliest claimed: 2000-02-15
- Assignees: MicroSolutions, Inc.
- Inventors: Derek J. Harper; Charles F. Milo
- Web page: https://patentgrep.com/patent/US6471688B1

## CPC

- A61M 5/14276: {specially adapted for implantation}
- A61M 5/145: using pressurised reservoirs, e.g. by means of pistons
- A61M 5/16827: {controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407)}
- A61M 2005/14513: {with secondary fluid driving or regulating the infusion}
- A61M 2205/16: with back-up system in case of failure
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug. The second drug may potentiate a therapeutic effect (such as an analgesic effect) of the first drug, as is the case with Sufentanil and Clonidine.

## Claims

### Claim 1

An implantable osmotic pump system, comprising:
a first osmotic pump including a first semipermeable membrane;
a second osmotic pump including a second semipermeable membrane, and
a single catheter attached to both the first and the second osmotic pumps.

### Claim 2 (depends on 1)

The pump system of claim 1, wherein the catheter includes a first lumen and a second lumen, the first lumen being connected to the first osmotic pump and the second lumen being connected to the second pump.

### Claim 3 (depends on 1)

The pump system of claim 1, wherein the catheter includes a single lumen with two side arms, one of the two side arms being attached to the first pump and the other of the two side arms being attached to the second pump, each of two side arms including an internal lumen that feeds into the single lumen.

### Claim 4 (depends on 1)

The pump system of claim 1, wherein the second semipermeable membrane is sealed by an impermeable membrane.

### Claim 5 (depends on 4)

The pump system of claim 4, wherein the impermeable membrane is disposed over and away from said one of the first and second semipermeable membranes so as to define a fluid tight compartment therewith, the fluid tight compartment being filled with a saturated saline solution.

### Claim 6 (depends on 4)

The pump system of claim 4, wherein the impermeable membrane is adapted to be punctured with a lancet when the pump system is implanted in a patient.

### Claim 7 (depends on 4)

The pump system of claim 4, wherein the impermeable membrane comprises at least one of titanium, stainless steel, platinum, platinum-iridium, polyethylene, PET and PETG.

### Claim 8 (depends on 4)

The pump system of claim 4, wherein the first and second pumps are preloaded with at least one pharmaceutical agent.

### Claim 9 (depends on 4)

The pump system of claim 4, wherein the first pump is preloaded with a first pharmaceutical agent at a first therapeutically effective concentration and wherein the second pump is preloaded with a second pharmaceutical agent at a second therapeutically effective concentration.

### Claim 10 (depends on 9)

The pump system of claim 9, wherein the first pharmaceutical agent is a same pharmaceutical agent as the second pharmaceutical agent.

### Claim 11 (depends on 10)

The pump system of claim 10, wherein the first concentration is a same concentration as the second concentration.

### Claim 12 (depends on 9)

The pump system of claim 9, wherein the first pharmaceutical agent is a different pharmaceutical agent than the second pharmaceutical agent.

### Claim 13 (depends on 9)

The pump system of claim 9, wherein the first pharmaceutical agent potentiates a therapeutic property of the second pharmaceutical agent.

### Claim 14 (depends on 9)

The pump system of claim 9, wherein the first pharmaceutical agent is an opioid and wherein the second pharmaceutical agent includes a drug that potentiates an analgesic property of the first pharmaceutical agent.

### Claim 15 (depends on 14)

The pump system of claim 14, wherein the first pharmaceutical agent includes Sufentanil and wherein the drug includes an alpha 2-adrenoreceptor agonist.

### Claim 16 (depends on 15)

The pump system of claim 15, wherein the alpha 2-adrenoreceptor agonist includes Clonidine.

### Claim 17 (depends on 4)

The pump system of claim 4, wherein the first pump is preloaded with a first opioid and wherein the first pump is adapted to infuse the first opioid at a first therapeutically effective range of concentration and wherein the second pump is preloaded with a second opioid and wherein the second pump is adapted to infuse the second opioid at a second therapeutically effective range of concentration after the semipermeable membrane is breached.

### Claim 18 (depends on 17)

The pump system of claim 17, wherein the first opioid includes one of Fentanyl and Sufentanil and wherein the second opioid includes one of Fentanyl and Sufentanil.

### Claim 19 (depends on 17)

The pump of claim 17, wherein the first opioid is a same opioid as the second opioid and wherein the second pump is adapted to infuse the second opioid at the first therapeutically effective range when the first pump is out of the first opioid, upon breaching the impermeable membrane.

### Claim 20 (depends on 1)

The pump system of claim 1, wherein the first and second pumps are preloaded with at least one pharmaceutical agent.

### Claim 21 (depends on 1)

The pump system of claim 1, wherein the first pump is preloaded with a first pharmaceutical agent at a first therapeutically effective concentration and wherein the second pump is preloaded with a second pharmaceutical agent at a second therapeutically effective concentration.

### Claim 22 (depends on 21)

The pump system of claim 21, wherein the first pharmaceutical agent is a same pharmaceutical agent as the second pharmaceutical agent.

### Claim 23 (depends on 22)

The pump system of claim 22, wherein the first concentration is a same concentration as the second concentration.

### Claim 24 (depends on 21)

The pump system of claim 21, wherein the first pharmaceutical agent is a different pharmaceutical agent than the second pharmaceutical agent.

### Claim 25 (depends on 21)

The pump system of claim 21, wherein the first pharmaceutical agent potentiates a therapeutic property of the second pharmaceutical agent.

### Claim 26 (depends on 21)

The pump system of claim 21, wherein the first pharmaceutical agent is an opioid and wherein the second pharmaceutical agent includes a drug that potentiates an analgesic property of the first pharmaceutical agent.

### Claim 27 (depends on 26)

The pump system of claim 26, wherein the first pharmaceutical agent includes Sufentanil and wherein the drug includes an alpha 2-adrenoreceptor agonist.

### Claim 28 (depends on 27)

The pump system of claim 27, wherein the alpha 2-adrenoreceptor agonist includes at least one of Clonidine and derivatives of Clonidine.

### Claim 29

A kit, comprising:
a first osmotic pump including a first semipermeable membrane;
a second osmotic pump including a second semipermeable membrane, and
a single catheter adapted to attach to both the first and the second osmotic pumps.

### Claim 30 (depends on 29)

The kit of claim 29, wherein the catheter includes a first lumen and a second lumen, the first lumen being adapted to connect to the first osmotic pump and the second lumen being adapted to connect to the second pump.

### Claim 31 (depends on 29)

The kit of claim 29, wherein the catheter includes a single lumen with two side arms, one of the two side arms being adapted to attach to the first pump and the other of the two side arms being adapted to attach to the second pump, each of two side arms including an internal lumen that feeds into the single lumen.

### Claim 32 (depends on 29)

The kit of claim 29, wherein the second semipermeable membrane is sealed by an impermeable membrane.

### Claim 33 (depends on 32)

The kit of claim 32, wherein the impermeable membrane is disposed over and away from the said one of the first and second semipermeable membrane so as to define a fluid tight compartment therewith, the fluid tight compartment being filled with a saturated saline solution.

### Claim 34 (depends on 32)

The kit of claim 32, further including a lancet configured to breach the impermeable membrane.

### Claim 35 (depends on 29)

The kit of claim 29, wherein the first osmotic pumps is preloaded with a first pharmaceutical agent and wherein the second pump is preloaded with a second pharmaceutical agent.

### Claim 36 (depends on 35)

The kit of claim 35, wherein the first pharmaceutical agent is a same pharmaceutical agent as the second pharmaceutical agent.

### Claim 37 (depends on 35)

The kit of claim 35, wherein the first pharmaceutical agent is a different pharmaceutical agent as the second pharmaceutical agent.

### Claim 38

A drug delivery method, comprising the steps of:
infusing a first drug at a first therapeutically effective range of concentration from a first implanted osmotic pump;
infusing a second drug at a second therapeutically effective range of concentration from a second implanted osmotic pump;
preventing the first and second drugs from mixing until both the first and second drugs reach an intended delivery site by attaching a catheter having a first and a second lumen to the first and second osmotic pumps, the first lumen being in fluid communication with the first osmotic pump and the second lumen being in fluid communication with the second osmotic pump, a free end of the catheter being disposed at the intended delivery site.

### Claim 39 (depends on 38)

The method of claim 38, wherein the first and second drugs are therapeutically effective for at least one therapy selected from pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy and chemotherapy.
