US20100280502A1 - Modular medical pump - Google Patents

Abstract

An implantable medical device comprises a fluid reservoir configured to store a therapeutic agent; a port configured to deliver the therapeutic agent to a patient; a medical pump subassembly configured to actively transfer the therapeutic fluid from the fluid reservoir to the port; and a housing that contains the fluid reservoir, the port and the medical pump subassembly. The medical pump subassembly is configured to facilitate mechanical and electrical testing of the medical pump subassembly as a standalone component.

Description

• This application claims the benefit of U.S. Provisional Application No. 61/174,457, filed Apr. 30, 2009, the entire content of which is incorporated by reference herein.
TECHNICAL FIELD
• The disclosure relates to medical pumps, and more particularly, but without limitation, to implantable medical devices including medical pumps.
BACKGROUND
• Medical pumps can be used to treat a variety of physiological, psychological, and emotional conditions. For some medical conditions, medical pumps can restore an individual to a more healthful condition and a fuller life. For example, medical pumps may be used for chronic delivery of therapeutic agents, such as drugs. As one specific example, a medical pump may be used to deliver insulin to a diabetic patient. Other examples include delivery of pain relief medication, e.g., to the intrathecal or epidural space of a patient, to alleviate chronic pain.
• Some medical pumps are implantable. Implantable medical pumps may be implanted at a location in the body of a patient and deliver a fluid medication through a catheter to a selected delivery site within the body of a patient. Typically, a catheter connects to a catheter connection port at the outlet of the medical pump and delivers a therapeutic agent at a programmed infusion rate to a predetermined location to treat a medical condition. An implantable medical pump is implanted by a clinician into a patient at a location that interferes as little as practicable with patient activity. For example, implantable medical pumps are often implanted subcutaneously in the lower abdomen of a patient. Implantable medical pumps may include self-sealing fluid reservoirs accessible through ports to facilitate in-service refilling by percutaneous injection.
SUMMARY
• In general, the disclosure relates to medical pumps that facilitate seal integrity testing of a medical pump subassembly prior to the full assembly of an implantable medical device including the medical pump. In addition, the disclosure describes techniques that may facilitate potting of an electromagnetic coil within a medical pump subassembly, which may speed up the assembly process of a medical pump.
• In one example, the disclosure is directed to an implantable medical device comprising: a fluid reservoir configured to store a therapeutic agent; a port configured to deliver the therapeutic agent to a patient; a medical pump subassembly configured to actively transfer the therapeutic fluid from the fluid reservoir to the port; and a housing that contains the fluid reservoir, the port and the medical pump subassembly. The medical pump subassembly is configured to facilitate mechanical and electrical testing of the medical pump subassembly as a standalone component.
• In another example, the disclosure is directed to a method of manufacturing a medical pump comprising: obtaining a medical pump subassembly; mechanically and electrically testing of the medical pump subassembly as a standalone component; and installing the medical pump subassembly within a housing of an implantable medical device. The implantable medical device includes: a fluid reservoir configured to store a therapeutic agent; a port configured to deliver the therapeutic agent to a patient; the medical pump subassembly; and the housing. The housing is configured to contain the fluid reservoir, the port and the medical pump subassembly.
• The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
BRIEF DESCRIPTION OF DRAWINGS
• FIG. 1 is a conceptual diagram illustrating an example of a fluid delivery system, which includes an implantable medical device (IMD) with a medical pump that is configured to deliver a therapeutic agent to a patient via a catheter.
• FIG. 2 is functional block diagram illustrating an exemplary IMD with a medical pump.
• FIGS. 3-6 illustrate components of an exemplary modular medical pump that facilitates seal testing of a pump coil subassembly.
• FIGS. 7-10 illustrate components of an exemplary modular medical pump that facilitates pump operation testing prior to assembling a modular pump in a bulkhead.
• FIGS. 11,12A and12B illustrate components of an exemplary modular medical pump that facilitates pump operation testing prior to assembling the modular pump in a bulkhead.
• FIG. 13 is a flowchart illustrating techniques for manufacturing a medical pump.
• FIG. 14 is a flowchart illustrating techniques for manufacturing a medical pump including a pump module.
• FIG. 15 is a flowchart illustrating techniques for delivering specified quantities of therapeutic fluid to patients using medical pumps with fixed stroke lengths.
• FIG. 16 is illustrates components of an exemplary modular medical pump that facilitates pump operation testing prior to assembling the modular pump in a bulkhead.
DETAILED DESCRIPTION
• Medical devices are useful for treating, managing or otherwise controlling various patient conditions or disorders, such as, but not limited to, pain (e.g., chronic pain, post-operative pain or peripheral and localized pain), tremor, movement disorders (e.g., Parkinson's disease), diabetes, epilepsy, neuralgia, chronic migraines, urinary or fecal incontinence, sexual dysfunction, obesity, gastroparesis, mood disorders, or other disorders. Some medical devices may be configured to deliver one or more therapeutic agents, alone or in combination with other therapies, such as electrical stimulation, to one or more target sites within a patient. For example, in some cases, a medical pump may deliver one or more pain-relieving drugs to patients with chronic pain, insulin to a patient with diabetes, or other fluids to patients with different disorders. A medical pump may be implanted in the patient for chronic therapy delivery (e.g., longer than a temporary, trial basis) or temporary delivery. Example therapeutic agents deliverable with medical pumps as described herein include, but are not limited to, insulin, morphine, hydromorphone, bupivacaine, clonidine, other analgesics, baclofen and other muscle relaxers and antispastic agents, genetic agents, antibiotics, nutritional fluids, hormones or hormonal drugs, gene therapy drugs, anticoagulants, cardiovascular medications or chemotherapeutics.
• A medical pump may be configured to deliver a therapeutic agent from the fluid reservoir to a patient according to a therapy program, which may, for example, specify a delivery rate of a fluid delivered to the patient by the medical pump. As another example, a therapy program may adjust the delivery rate automatically based on physiological characteristics of a patient. In some instances, an external controller may be used to alter the therapy program as well as send and receive data relating to the operation of the medical pump. In different examples, an external controller may be operated by either one or both of a clinician and the patient.
• Drug therapies may dictate a specific target dose resolution in order meet therapy efficacy requirements; insulin therapy is one example. In accordance with the techniques disclosed herein, fully functional pump subassemblies can be built, calibrated and labeled. The calibration may include precisely measuring the fluid volume for a single pump stoke and storing a representation of that volume in memory for future therapy delivery. In addition, the techniques described herein provide for pump subassemblies with customized dosage resolutions, i.e., stroke volume and drug types (e.g. insulin) that can be “dropped in” (like a car engine) to a common pump framework, such as a bulkhead.
• In addition, in accordance with the techniques disclosed herein, fully functional pump subassemblies may greatly reduce development cycle time, manufacturing cost, scrap, and piece part costs since the pump subassemblies can be built on a feeder line and functionally tested as standalone components prior to being integrated into the pump framework. Further aspects of this disclosure include pump subassemblies designs with welding features that provide high weld yields, i.e., a low rate of defective welds.
• In accordance with the techniques disclosed herein, a fully functional pump subassembly can include an electromagnetic drive coil, electromagnetic material to drive flux, a reciprocating electromagnetic actuator, a piston, a bore, a check valve, a stroke length setter, and a bacterial filter. In some examples, a fully functional pump subassembly includes a titanium sleeve which comprises the pump bore, spring recess, valve seat and valve fastening features integrated with electromagnetic drive coil components. A titanium weld ring is integrated to electromagnetic drive coil components to facilitate hermetically attaching pump components. A fully functional pump subassembly may include a bacterial filter with a cover including stroke setting features. Stroke setting feature integrated to cover that encloses the pumping actuator can provide a hermetic flow path of subassembly. In addition, a fully functional pump subassembly can include a valve assembly housed within the titanium sleeve. A “sandwich weld” can be used to permanently and hermetically weld the electromagnetic drive coil components to the pump enclosure component by sealing the titanium weld ring, a barrier plate over the drive coil and the cover with a single weld. Some examples included in this disclosure can provide for testing pumping functionality (seal testing, electrical testing and mechanical pump operation testing) of the pump subassembly as a standalone component, i.e., without installing the pump subassembly within the common pump framework. As referred to herein, mechanical testing includes testing the mechanical operation of the pump piston and or pump valve and electrical testing includes testing the functionality and/or integrity of the pump coil. Seal testing includes looking for defects or leaks in welds and/or other seals of a pump or pump subassembly. These and other examples are described with respect to the figures included in this disclosure.
• FIG. 1 is a conceptual diagram illustrating an example of atherapy system10 includingIMD12, which is configured to deliver at least one therapeutic agent, such as a pharmaceutical agent, insulin, pain relieving agent, anti-inflammatory agent, gene therapy agent, or the like, to a target site withinpatient16 viacatheter18, which is coupled toIMD12. In one example,catheter18 may comprise a plurality of catheter segments. In other examples,catheter18 may be a unitary catheter. In the example shown inFIG. 1, the target site is proximate tospinal cord14 ofpatient16. Aproximal end18A ofcatheter18 is coupled toIMD12, while adistal end18B ofcatheter18 is located proximate to the target site.Therapy system10 also includesexternal programmer20, which wirelessly communicates withIMD12 as needed, such as to provide or retrieve therapy information or control aspects of therapy delivery (e.g., modify the therapy parameters, turnIMD12 on or off, and so forth). Whilepatient16 is generally referred to as a human patient, other mammalian or non-mammalian patients are also contemplated.
• Generally,IMD12 has an outer housing that is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids, such as titanium or biologically inert polymers.IMD12 may be implanted within a subcutaneous pocket close to the therapy delivery site. For example, in the example shown inFIG. 1,IMD12 is implanted within an abdomen ofpatient16. In other examples,IMD12 may be implanted within other suitable sites withinpatient16, which may depend, for example, on the target site withinpatient16 for the delivery of the therapeutic agent.
• In accordance with the techniques described herein,IMD12 includes a modular medical pump. A modular medical pump is a medical pump that facilitates assembly of at least a portion of the pump components separately from the pump housing (or bulkhead) ofIMD12 containing a fluid a fluid reservoir, a port and a medical pump subassembly. An IMD with a modular medical pump may have a lower production cost compared to an IMD in which all or substantially all of the medical pump assembly occurs in conjunction with a bulkhead.
• Catheter18 may be coupled toIMD12 either directly or with the aid of a catheter extension (not shown inFIG. 1). In the example shown inFIG. 1,catheter18 traverses from the implant site ofIMD12 to one or more target sites proximate tospine14.Catheter18 is positioned such that one or more fluid delivery outlets ofcatheter18 are proximate to the one or more target sites withinpatient16.IMD12 delivers a therapeutic agent to the one or more target sites proximate tospinal cord14 with the aid ofcatheter18.IMD12 can be configured for intrathecal drug delivery into the intrathecal space, as well as epidural delivery into the epidural space, both of which surroundspinal cord14. The epidural space (also known as “extradural space” or “peridural space”) is the space within the spinal canal (formed by the surrounding vertebrae) lying outside the dura mater, which encloses the arachnoid mater, subarachnoid space, the cerebrospinal fluid, andspinal cord14. The intrathecal space is within the subarachnoid space ofspinal cord14, which is past the epidural space and dura mater and through the theca ofspinal cord14.
• As already mentioned, in some applications,therapy system10 can be used to reduce pain experienced bypatient16. In such an application,IMD12 can deliver one or more therapeutic agents to patient16 according to one or more dosing programs that set forth different therapy parameters, such as a therapy schedule specifying programmed doses, dose rates for the programmed doses, and specific times to deliver the programmed doses. The dosing programs may be a part of a program group for therapy, where the group includes a plurality of dosing programs and/or therapy schedules. In some examples,IMD12 may be configured to deliver a therapeutic agent to patient16 according to different therapy schedules on a selective basis.IMD12 may include a memory to store one or more therapy programs, instructions defining the extent to whichpatient16 may adjust therapy parameters, switch between dosing programs, or undertake other therapy adjustments.Patient16 or a clinician may select and/or generate additional dosing programs for use byIMD12 viaexternal programmer20 at any time during therapy or as designated by the clinician.
• In some examples,multiple catheters18 may be coupled toIMD12 to target the same or different tissue or nerve sites withinpatient16. Thus, although asingle catheter18 is shown inFIG. 1, in other examples,system10 may include multiple catheters orcatheter18 may define multiple lumens for delivering different therapeutic agents to patient16 or for delivering a therapeutic agent to different tissue sites withinpatient16. Accordingly, in some examples,IMD12 may include a plurality of reservoirs for storing more than one type of therapeutic agent. In some examples,IMD12 may include a single long tube that contains the therapeutic agent in place of a reservoir. However, for ease of description, anIMD12 including a single reservoir is primarily discussed herein with reference to the example ofFIG. 1.
• Programmer20 is an external computing device that is configured to wirelessly communicate withIMD12. For example,programmer20 may be a clinician programmer that the clinician uses to communicate withIMD12. Alternatively,programmer20 may be a patient programmer that allows patient16 to view and modify therapy parameters. The clinician programmer may include additional or alternative programming features, relative to the patient programmer. For example, more complex or sensitive tasks may only be allowed by the clinician programmer to prevent patient16 from making undesired changes to the operation ofIMD12.
• Programmer20 may be a hand-held computing device that includes a display viewable by the user and a user input mechanism that can be used to provide input toprogrammer20. For example,programmer20 may include a display screen (e.g., a liquid crystal display or a light emitting diode display) that presents information to the user. In addition,programmer20 may include a keypad, buttons, a peripheral pointing device, touch screen, voice recognition, or another input mechanism that allows the user to navigate though the user interface ofprogrammer20 and provide input.
• Ifprogrammer20 includes buttons and a keypad, the buttons may be dedicated to performing a certain function, i.e., a power button, or the buttons and the keypad may be soft keys that change in function depending upon the section of the user interface currently viewed by the user. Alternatively, the screen (not shown) ofprogrammer20 may be a touch screen that allows the user to provide input directly to the user interface shown on the display. The user may use a stylus or their finger to provide input to the display.
• In other examples, rather than being a handheld computing device or a dedicated computing device,programmer20 may be a larger workstation or a separate application within another multi-function device. For example, the multi-function device may be a cellular phone, personal computer, laptop, workstation computer, or personal digital assistant that can be configured to an application to simulateprogrammer20. Alternatively, a notebook computer, tablet computer, or other personal computer may execute an application to function asprogrammer20, e.g., with a wireless adapter connected to the personal computer for communicating withIMD12.
• Whenprogrammer20 is configured for use by the clinician,programmer20 may be used to transmit initial programming information toIMD12. This initial information may include hardware information forsystem10 such as the type ofcatheter18, the position ofcatheter18 withinpatient16, the type and amount, e.g., by volume of therapeutic agent(s) delivered byIMD12, a refill interval for the therapeutic agent(s), a baseline orientation of at least a portion ofIMD12 relative to a reference point, therapy parameters of therapy programs stored withinIMD12 or withinprogrammer20, and any other information the clinician desires to program intoIMD12. In accordance with some examples of this disclosure, the refill interval may be based on an expiration time for the therapeutic agent(s).
• The clinician usesprogrammer20 toprogram IMD12 with one or more therapy programs that define the therapy delivered byIMD12. During a programming session, the clinician may determine one or more dosing programs that may provide effective therapy topatient16.Patient16 may provide feedback to the clinician as to the efficacy of a specific program being evaluated or desired modifications to the dosing program. Once the clinician has identified one or more programs that may be beneficial topatient16,patient16 may continue the evaluation process and determine which dosing program or therapy schedule best alleviates the condition ofpatient16 or otherwise provides efficacious therapy topatient16.
• The dosing program information may set forth therapy parameters, such as different predetermined dosages of the therapeutic agent (e.g., a dose amount), the rate of delivery of the therapeutic agent (e.g., rate of delivery of the fluid), the maximum acceptable dose, a time interval between successive supplemental boluses such as patient-initiated boluses (e.g., a lock-out interval), a maximum dose that may be delivered over a given time interval, and so forth.IMD12 may include a feature that prevents dosing the therapeutic agent in a manner inconsistent with the dosing program.Programmer20 may assist the clinician in the creation/identification of dosing programs by providing a methodical system of identifying potentially beneficial therapy parameters.
• A dosage of a therapeutic agent, such as a drug, may be expressed as an amount of drug, e.g., measured in milligrams, provided to the patient over a particular time interval, e.g., per day or twenty-four hour period. This dosage amount may convey to the caregiver an indication of the probable efficacy of the drug and the possibility of side effects of the drug. In general, a sufficient amount of the drug should be administered in order to have a desired therapeutic effect, such as pain relief. However, the amount of the drug administered to the patient should be limited to a maximum amount, such as a maximum daily dose, in order not to avoid potential side effects. Program information specified by a user viaprogrammer20 may be used to control dosage amount, dosage rate, dosage time, maximum dose for a given time interval (e.g., daily), or other parameters associated with delivery of a drug or other fluid byIMD12. Dosage may also prescribe particular concentrations of active ingredients in the therapeutic agent delivered byIMD12 topatient16.
• In some cases,programmer20 may also be configured for use bypatient16. When configured as the patient programmer,programmer20 may have limited functionality in order to prevent patient16 from altering critical functions or applications that may be detrimental topatient16. In this manner,programmer20 may only allowpatient16 to adjust certain therapy parameters or set an available range for a particular therapy parameter. In some cases, a patient programmer may permit the patient to controlIMD12 to deliver a supplemental, patient bolus, if permitted by the applicable therapy program administered by the IMD, e.g., if delivery of a patient bolus would not violate a lockout interval or maximum dosage limit.Programmer20 may also provide an indication topatient16 when therapy is being delivered or whenIMD12 needs to be refilled or when the power source withinprogrammer20 orIMD12 need to be replaced or recharged.
• Whetherprogrammer20 is configured for clinician or patient use,programmer20 may communicate toIMD12 or any other computing device via wireless communication.Programmer20, for example, may communicate via wireless communication withIMD12 using radio frequency (RF) telemetry techniques known in the art.Programmer20 may also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared (IR) communication according to the IRDA specification set, or other standard or proprietary telemetry protocols.Programmer20 may also communicate with another programming or computing device via exchange of removable media, such as magnetic or optical disks, or memory cards or sticks. Further,programmer20 may communicate withIMD12 and another programmer via remote telemetry techniques known in the art, communicating via a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example.
• In other applications oftherapy system10, the target therapy delivery site withinpatient16 may be a location proximate to sacral nerves (e.g., the S2, S3, or S4 sacral nerves) inpatient16 or any other suitable nerve, organ, muscle or muscle group inpatient16, which may be selected based on, for example, a patient condition. For example,therapy system10 may be used to deliver a therapeutic agent to tissue proximate to a pudendal nerve, a perineal nerve or other areas of the nervous system, in which cases,catheter18 would be implanted and substantially fixed proximate to the respective nerve. As further examples,catheter18 may be positioned to deliver a therapeutic agent to help manage peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve therapy, intercostal nerve therapy, gastric stimulation for the treatment of gastric motility disorders and/or obesity, muscle stimulation, for mitigation of other peripheral and localized pain (e.g., leg pain or back pain). As another example,catheter18 may be positioned to deliver a therapeutic agent to a deep brain site or within the heart (e.g., intraventricular delivery of the agent). Delivery of a therapeutic agent within the brain may help manage any number of disorders or diseases. Example disorders may include depression or other mood disorders, dementia, obsessive-compulsive disorder, migraines, obesity, and movement disorders, such as Parkinson's disease, spasticity, and epilepsy.Catheter18 may also be positioned to deliver insulin to a patient with diabetes.
• Examples of therapeutic agents thatIMD12 may be configured to deliver include, but are not limited to, insulin, morphine, hydromorphone, bupivacaine, clonidine, other analgesics, genetic agents, antibiotics, nutritional fluids, analgesics, hormones or hormonal drugs, gene therapy drugs, anticoagulants, cardiovascular medications or chemotherapeutics.
• FIG. 2 is a functional block diagram illustrating components of an example ofIMD12, which includesrefill port26,reservoir30,processor38,memory40,telemetry module42,power source44,medical pump46,internal tubing32, andcatheter connection port36. As discussed in further detail below,medical pump46 may facilitate mechanical, electrical and seal testing as a standalone component.Catheter connection port36 is one example of a port for delivering a therapeutic fluid to a patient; in other examples,IMD12 may deliver a therapeutic agent without a catheter.Medical pump46 may be a mechanism that delivers a therapeutic agent in some metered or other desired flow dosage to the therapy site withinpatient16 fromreservoir30 via thecatheter18.Refill port26 may comprise a self-sealing injection port. The self-selaing injection port may include a self-sealing membrane to prevent loss of therapeutic agent delivered toreservoir30 viarefill port26. After a delivery system, e.g., a hypodermic needle, penetrates the membrane ofrefill port26, the membrane may seal shut when the needle is removed fromrefill port26.Internal tubing32 is a segment of tubing that runs fromreservoir30, around or throughmedical pump46 tocatheter connection port36.
• Processor38 controls the operation ofmedical pump46 with the aid of instructions associated with program information that is stored inmemory40. For example, the instructions may define dosing programs that specify the amount of a therapeutic agent that is delivered to a target tissue site withinpatient16 fromreservoir30 viacatheter18. The instructions may further specify the time at which the agent will be delivered and the time interval over which the agent will be delivered. The amount of the agent and the time over which the agent will be delivered are a function of the dosage rate at which the fluid is delivered. In other examples, a quantity of the agent may be delivered according to one or more physiological characteristics of a patient, e.g., physiological characteristics sensed by one or more sensors (not shown) implanted within a patient as part of therapy system10 (FIG. 1). Components described as processors withinIMD12 andexternal programmer20 may each comprise one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination.
• Memory40 may include any volatile or non-volatile media, such as a random access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. As mentioned above,memory40 may store program information including instructions for execution byprocessor38, such as, but not limited to, therapy programs, historical therapy programs, timing programs for delivery of fluid fromreservoir30 tocatheter18, and any other information regarding therapy ofpatient16.Memory40 may include separate memories for storing instructions, patient information, therapy parameters (e.g., grouped into sets referred to as “dosing programs”), therapy adjustment information, program histories, and other categories of information such as any other data that may benefit from separate physical memory modules.
• Telemetry module42 inIMD12, as well as telemetry modules in a controller, such asprogrammer20, may accomplish communication by RF communication techniques. In addition,telemetry module42 may communicate withprogrammer20 via proximal inductive interaction ofIMD12 withexternal programmer20.Processor38controls telemetry module42 to send and receive information.
• Power source44 delivers operating power to various components ofIMD12.Power source44 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. In the case of a rechargeable battery, recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil withinIMD12. In some examples, power requirements may be small enough to allowIMD12 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time. As a further alternative, an external inductive power supply could transcutaneouslypower IMD12 whenever measurements are needed or desired.
• FIGS. 3-6 illustrate components ofmedical pump100. For example,medical pump100 may be part of an IMD, such as IMD12 (FIG. 1).Medical pump100 includes modularpump coil subassembly120, piston/pole subassembly160,cover170,bulkhead180 andfilter190. In accordance with the techniques described herein, the configuration ofmedical pump100 facilitates electrical and seal integrity testing of modularpump coil subassembly120 as a standalone component, i.e., prior to assembly of modularpump coil subassembly120 withinbulkhead180.
• As shown inFIG. 3,bulkhead180 includes cup-mountingbay182 to receive modularpump coil subassembly120 and filter-mountingbay184 to receivefilter190.Fluid passageway186 connects cup-mountingbay182 to filter-mountingbay184.Bulkhead180 comprises a biocompatible material. As examples,bulkhead180 may include a stainless steel alloy, a titanium alloy or other biocompatible material.
• During the operation ofmedical pump100, therapeutic fluid flows throughfilter190 and into cup-mountingbay182 viafluid passageway186. Within cup-mountingbay182, the fluid enters an enclosure including piston/pole subassembly160 throughholes174 incover170. Once within the enclosure undercover170, the fluid enterscentral aperture150 and is pushed by the motion ofpiston166 through one-way valve152 (FIG. 4A). After passing throughvalve152, the therapeutic fluid is directed to one or more target sites within a patient. For example, as shown inFIG. 1, a catheter may be used to direct therapeutic fluid from a medical pump to a target site within a patient.
• Filter190 includes three elements:filter cover194,filter element192 andfilter base196.Base196 forms a seal with filter-mountingbay184 to prevent any therapeutic fluid from bypassingfilter element192 prior to enteringfluid passageway186.Filter cover194 serves to compressfilter element192 andbase196 to provide a seal betweenfilter element192 andbase196 as well as a seal betweenbase196 andbulkhead180.Filter cover194 may be attached tobulkhead180 by interference fit, screws (not shown) or other suitable techniques. Each of the elements offilter190 comprise corrosion-resistant materials. As an example,base196 may comprise a deformable material, such as a polymer or silicone rubber. In other examples,base196 may comprise a stainless steel or other suitable material. As another example, cover194 may comprise a polymer, a stainless steel or other suitable material.
• Pump coil subassembly120 operates to drive piston/pole subassembly160 during a pump stroke ofmedical pump100. The components of modularpump coil subassembly120 are shown inFIGS. 4A-4B.Pump coil subassembly120 includescup assembly140,electromagnetic coil134,barrier plate130 and one-way valve152.Electromagnetic coil134 fits underneathbarrier plate130 and withinrecess149 ofcup assembly140. In addition, one-way valve152 seals againstseat151 within the end ofsleeve144 ofcup assembly140opposite barrier plate130.
• As shown inFIG. 5,cup assembly140 includesmagnetic cup141,weld ring146 andsleeve144.Magnetic cup141forms recess149. Withinrecess149,magnetic cup141 includesprotrusion145. In addition,magnetic cup141 formscentral aperture150 inprotrusion145, which receivessleeve144. As an example,sleeve144 may be interference fit withincentral aperture150 or secured withincentral aperture150 by other techniques.Weld ring146 surroundsrecess149 and fits withingroove143 ofmagnetic cup141.Weld ring146 may be interference fit to groove143 ofmagnetic cup141 or secured by other techniques.Magnetic cup141 comprises a highly magnetic material. The highly magnetic material ofmagnetic cup141 efficiently magnetizes in response to current throughelectromagnetic coil134. As an example,magnetic cup141 may comprise a highly magnetic steel alloy. As another example,magnetic cup141 may comprise a highly magnetic stainless steel alloy such as 430F. However, as highly magnetic materials are generally susceptible to corrosion,magnetic cup141 is separated from the flow path of fluid being pumped bymedical pump100 to prevent corrosion ofmagnetic cup141. As will be discussed in greater detail,weld ring146 combines withbulkhead180,barrier plate130 andsleeve144 to separatemagnetic cup141 from the flow path.
• Electromagnetic coil134 comprises one or more insulated conductors arranged in a multitude of turns. As examples,electromagnetic coil134 may comprise a single continuous conductor or more than one conductor electrically connected in series or in parallel.Electromagnetic coil134 includesflex circuit136, which provides the electrical connections used to deliver current toelectromagnetic coil134. Withinmedical pump100, delivering current toelectromagnetic coil134 magnetizesmagnetic cup141 in order to attractpole162 for a pump stroke ofmedical pump100.Flex circuit136 fits throughhole142 ofmagnetic cup141 and also throughhole183.Hole183 is formed in the bottom of cup-mountingbay182 inbulkhead180 and lines up withhole142 to receiveflex circuit136.
• Barrier plate130 coversrecess149 to encloseelectromagnetic coil134 withinrecess149.Barrier plate130forms mating aperture131, which provides an inner diameter ofbarrier plate130.Mating aperture131 coincides withcentral aperture150 ofmagnetic cup141. The inner diameter ofbarrier plate130 is sealed tosleeve144, whereas the outer diameter ofbarrier plate130 is sealed toweld ring146. For this reason, the inner diameter ofbarrier plate130 may be smaller than the inner diameter ofmagnetic cup141, but larger than the inner diameter ofsleeve144.Barrier plate130 comprises a relatively thin material to provide the best magnetic performance forpump100 while maintaining sufficient strength and stiffness to isolateelectromagnetic coil134 andmagnetic cup141 from the flow path. For example,barrier plate130 may have a thickness between about 0.0005 inches to about 0.10 inches. As other examples,barrier plate130 may have a thickness between about 0.001 inches to about 0.010 inches, a thickness between about 0.001 inches to about 0.005 inches, a thickness of less than about 0.010 inches, a thickness of less than about 0.005 inches, a thickness between about 0.00175 inches to about 0.00225 inches, or a thickness of about 0.002 inches.Barrier plate130 comprises a biocompatible material. As examples,barrier plate130 may include a stainless steel alloy, a titanium alloy or other biocompatible material.
• Piston/pole subassembly160 includespiston166 andpole162. Piston/pole subassembly160 is positioned such thatpiston166 is located withincentral aperture150 of modularpump coil subassembly120.Spring132 is located withincentral aperture150 adjacentdistal end167 ofpiston166.Spring132 functions to bias piston/pole subassembly160 away from modularpump coil subassembly120 such thatpole162 is spaced apart frombarrier plate130.Piston166 may be interference fit topole162 or secured topole162 by other suitable techniques.Pole162 comprises a magnetic material that is attracted tocup assembly140 to produce a pump stroke. As an example,pole162 may comprise a stainless steel. Betweenholes174 formed incover170 andcentral aperture150, therapeutic fluid flows throughholes168 inpole166 as well as through a gap betweenpole162 and inner surface ofsidewall176 ofcover170. Becausepole162 is within the fluid flow path, the material ofpole162 should resist corrosion. As an example,pole162 may comprise a magnetic stainless steel alloy, such as AL29-4. Likewise,piston166 is also located within the fluid flow path and should also resist corrosion. As an example,piston166 may comprise sapphire material, which can limit wear between piston andsleeve144 caused by the pumping action ofmedical pump100. As other examples,piston166 may comprise a metal material, such as a stainless steel or titanium alloy. In some examples, piston/pole subassembly160 may comprises a unitary component consisting of a single magnetic material such as a stainless steel alloy.
• Cover170 mounts tobarrier plate130 to form an enclosure containing piston/pole subassembly160 andspring132. Whenmedical pump100 is fully-assembled,cover170 is secured tobulkhead180 within cup-mountingbay182. As examples, cover170 may be interference fit within cup-mountingbay182 or secured tobulkhead180 using a weld joint, one or more screws or other techniques. Cover170 includesholes174, which allow the therapeutic fluid passing throughmedical pump100 to enter the enclosure formed bycover170 after passing throughfluid passageway186. Cover170 also includesprotrusions172, which are located on its interior surface adjacent topole162.Protrusions172 serve constrain the motion of piston/pole subassembly160 thereby limiting the maximum stroke length of a pump stoke. In this manner, the height of protrusion s172 may be selected to set the stroke length of a pump stroke. As the volume of therapeutic fluid delivered bymedical pump100 per pump stroke directly (pump-stroke volume) relates to the stroke length, the design ofmedical pump100 facilitates different pump-stroke volumes simply by changing the height ofprotrusions172. The other components ofmedical pump100 can be identical for different pump-stroke volumes. However, the pump-stroke volume also depends on the diameter ofpiston166 and the inner diameter ofsleeve144, and can also be selected in combination with a stroke length to provide selected pump-stroke volumes.
• Piston/pole subassembly160 actuates within an enclosure between an interior surface ofcover170 and an exterior surface ofbarrier plate130.Spring132 biases piston/pole subassembly160 away fromvalve152 and againstprotrusions172 ofcover170. The motion of piston/pole subassembly160 is driven byelectromagnetic coil134. Specifically, during a pump stroke, current throughelectromagnetic coil134 serves to magnetizemagnetic cup141 to attractpole162. The magnetic attraction force betweenpole162 andmagnetic cup141 overcomes the force ofspring132 to create a pumping action ofpiston166. The motion ofpiston166 forces therapeutic fluid withincentral aperture150 and adjacent todistal end167 ofpiston166 through one-way valve152.
• Following a pump stroke, current throughelectromagnetic coil134 stops, andspring132 returns piston/pole subassembly160 to its original position againstcover170. Asspring132 moves piston/pole subassembly160, therapeutic fluid flows through a small gap betweenpiston166 and the inner surface ofsleeve144 to fill the growing space withincentral aperture150 adjacent todistal end167 ofpiston166. While some therapeutic fluid could technically flow back though the gap betweenpiston166 and the inner surface ofsleeve144 during a pump stroke, the speed of a pump stroke combined with the viscosity of the therapeutic fluid allows any amount of therapeutic fluid flowing back though the gap betweenpiston166 and the inner surface ofsleeve144 during a pump stroke to be negligible.
• The size of the gap betweenpiston166 and the inner surface ofsleeve144 may be selected according to the fluid being pumped throughmedical pump100. For example, a higher viscosity fluid may take more time than a lower viscosity fluid to flow through gap betweenpiston166 and the inner surface ofsleeve144 for a given gap and a given spring force fromspring132. The size of the gap as well as the spring force fromspring132 may be selected to limit backflow during a pump stroke as well as provide a return stroke fast enough for a desired pump stroke rate according to the fluid properties of a particular therapeutic to be pumped throughmedical pump100. Generally the gap betweenpiston166 and the inner surface ofsleeve144 should be selected to prevent backflow whilespring132 should provide a near minimal spring force necessary to accomplish a return stroke fast enough to provide a desired pump stroke rate. These are examples of howmedical pump100 can be customized to suit a particular application with limited modification.
• Generally, a return stroke is relatively slow compared to a pump stroke. As an example, a pump stoke may take about 0.01 to 100 milliseconds, whereas a return stroke may take about 0.5 to 20 seconds. As another example, a pump stoke may take about 1 to 10 milliseconds, whereas a return stroke may take about 0.1 to 20 seconds. As another example, a pump stoke may take about 1 to 5 milliseconds, whereas a return stroke may take about 0.5 to 5 seconds. As yet another example, a pump stoke may take about 3 milliseconds, whereas a return stroke may take about 2 seconds. In this manner, the configuration ofpiston166 andsleeve144 acts as a one-way valve during the operation ofmedical pump100.
• Therapeutic fluid pushed bypiston166 during a pump stroke exitsmedical pump100 through one-way valve152. One-way valve152 includes three components:disc154,spring156 andbonnet158.Spring156 functions tobias disc154 againstseat151 ofsleeve144.Bonnet158 functions to holdspring156 in place. As an example,bonnet158 may be interference fit tosleeve144. In other examples,bonnet158 may be attached tosleeve144 using a weld joint, screws or by other suitable techniques. In yet other examples,valve152 may be located remotely. In such examples, a sealed fluid passageway, such as a catheter, would connectsleeve144 andvalve152.Bonnet158 includes holes that provide fluid passageways throughbonnet158. When one-way valve152 is closed,disc154 seals to seat151 ofsleeve144. The configuration of one-way valve152 may be referred to as a lift check valve. In other examples, different valve configurations may be used including, but not limited to, ball check valves, diaphragm valves, gate valves and other valves. The design ofmedical pump100 allows different valves to be selected for one-way valve152 as desired according to a particular therapeutic to be pumped throughmedical pump100 and the desired pumping characteristics. Generally, one-way valve152 should be selected to minimize a pressure differential in the fluid flow path at one-way valve152 while maintaining a fluid seal except during pump strokes.
• As best shown inFIG. 6,magnetic cup141 is separated from the flow path of fluid being pumped bymedical pump100. In the manufacture of modularpump coil subassembly120, the outer diameter ofbarrier plate130 is sealed toweld ring146 to encloseelectromagnetic coil134 withinrecess149. In addition, the interior diameter ofbarrier plate130 is sealed tosleeve144. As shown inFIG. 6,barrier plate130 is sealed tosleeve144 with a first weld joint, i.e., weld joint122, andbarrier plate130 is sealed toweld ring146 with a second weld joint, i.e., weld joint124. In other examples,barrier plate130 may be sealed toweld ring146 andsleeve144 using other techniques.Weld ring146 forms notch147, which is adjacent to an outer perimeter ofbarrier plate130. Weld joint124 is at least partially located withinnotch147. As an example, the external diameter ofbarrier plate130 may be substantially the same as the inner diameter ofnotch147.
• The combination ofbarrier plate130,sleeve144,weld ring146 andweld joints122,124 serves to fluidically separate an interior ofmagnetic cup141, from an external surface ofbarrier plate130, i.e., the surface oppositemagnetic cup141, and thus separate the interior ofmagnetic cup141 from fluid being pumped throughmagnetic pump100. In addition, modularpump coil subassembly120 is installed withinbulkhead180 such thatweld ring146 is sealed to cup-mountingbay182 to fluidically separate an exterior ofmagnetic cup141 from an external surface ofbarrier plate130, and thus separate the exterior ofmagnetic cup141 from fluid being pumped throughmagnetic pump100.
• As examples,weld ring146 may be interference fit withinbulkhead180 within cup-mountingbay182 or sealed tobulkhead180 with a weld joint or other suitable techniques. In this manner, the design ofmedical pump100 completely separatesmagnetic cup141 from fluid being pumped throughmagnetic pump100. This allowsmagnetic cup141 to be formed from a highly magnetic material, such as a highly magnetic steel, which may have a low resistance to corrosion. In contrast,weld ring146,sleeve144,barrier plate130 andbulkhead180 comprise materials that resist corrosion. Examples of suitable materials include stainless steel and titanium alloys.
• The design ofcup assembly140 and, more specifically,weld ring146, allows modularpump coil subassembly120 to be assembled separately frombulkhead180 and tested as a standalone component. In addition, the design ofcup assembly140, includingweld ring146, also allows testing the integrity of seals at the inner and outer diameter ofbarrier plate130 before mounting modularpump coil subassembly120 tobulkhead180 and electrical testing ofelectromagnetic coil134. In one example of a manufacturing process ofmagnetic pump100, the integrity of weld joints122,124 is tested before pottingcoil134 withincup assembly140 to ensure a tight seal at weld joints122,124. Potting involves encasingcoil134 within a non-conductive material withinrecess149 by pouring (or forcing) a non-conductive potting material though hole139 (FIG. 4B) inmagnetic cup141 afterbarrier plate130 is sealed toweld ring146 andsleeve144. Because the seals separating the interior ofmagnetic cup141 from the external surface ofbarrier plate130, i.e., weld joints122,124 are part ofcup assembly140 and do not includebulkhead180, the design of modularpump coil subassembly120 allowscoil134 to be potted withincup assembly140 beforecup assembly140 is mounted tobulkhead180 within cup-mountingbay182. The design ofmedical pump100 also allows electrical testing ofelectromagnetic coil134 after potting and before mounting modularpump coil subassembly120 tobulkhead180.
• In general, potting includes allowing the potting material to “set-up” or harden after filling the remaining space withinrecess149 within the potting material. As examples, a potting material may be an epoxy or a polymer.Potting coil134 withincup assembly140 can take a significant amount of time to allow the potting material to harden. Depending on the potting material, potting can take between about 1 to 24 hours. As another example, potting can take about between about 2 to 12 hours. As another example, potting can take about 8 hours. Because the potting process takes a significant amount of time, separating potting process frombulkhead180 streamlines the assembly ofmedical pump100.
• In addition, during the manufacturing of a plurality ofmedical pumps100, some of weld joints122,124 will not form proper seals. In such instances, thefaulty cup assembly140 may be removed from the assembly process. In contrast, in an alternative design in which the outer diameter ofbarrier plate130 is sealed directly to cup-mountingbay182 ofbulkhead180, e.g., using a weld joint, instead of indirectly viaweld ring146, testing the integrity of the seal betweenbarrier plate130 and cup-mountingbay182 could only be performed after mountingmagnetic cup141 within cup-mountingbay182. In such an alternative design, in the event of a bad seal, the entire assembly, includingbulkhead180, would have to be removed from the assembly process. In this manner, the design ofmedical pump100 provides the advantage of facilitating a manufacturing process that does not waste abulkhead180 in the event of a bad seal at one of weld joints122,124.
• While numerous techniques may be suitable to manufacturecup assembly140, the following techniques may be included in themanufacture cup assembly140. In each stage of the following description, components are referred to using the same names as these components have in a full-assembledmedical pump100, even though such components may not yet include each its associated features provided during the previous description ofmedical pump100.
• Central aperture150 is machined inmagnetic cup141 to receivesleeve144; likewise,sleeve144 is bored to acceptpiston166. Next,sleeve144 is interference fit withincentral aperture150 ofmagnetic cup141. Then,valve seat151 is finish-machined to acceptvalve152, and the bore ofsleeve144 is also finish-machined topiston166. Following this step, the combinedmagnetic cup141/sleeve144 is passivated using acid and vacuum-baked. Vacuum-baking may limit the occurrence of corrosion at the interface betweenmagnetic cup141 andsleeve144 and the interface betweenmagnetic cup141 andweld ring146 during future heat treatment processes. For example, such corrosion may be caused by particles left behind by tooling used in the finish machining. Following the vacuum-baking, the combinedmagnetic cup141/sleeve144 is heat treated. The heat treatment forms a hard titanium-oxide layer onsleeve144, which improves the wear resistance ofsleeve144 to limit wear caused by the motion ofpiston166.
• Next,groove143 is machined inmagnetic cup141, andweld ring146 is machined from a titanium alloy to fitgroove143.Weld ring146 is then interference fit withingroove143 ofmagnetic cup141. Then,cup assembly140 is finished-machined. Finish machining includingmachining notch147 inweld ring146 as well as formingrecess149 withinmagnetic cup141. Formingrecess149 withinmagnetic cup141 includes leavingprotrusion145 in place. The finish machining also includes facing-off the upper surfaces ofmagnetic cup141, includingprotrusion145,sleeve144 andweld ring146 to ensure these surfaces are substantially coplanar. It is useful to ensure that the upper surfaces ofmagnetic cup141 are substantially coplanar to improve the likelihood that weld joints122,124 will form proper seals withbarrier plate130. Following this step, thecup assembly140 is again passivated with acid and vacuum-baked. One-way valve152 is then seated invalve seat151 ofsleeve144. The forgoing description provides an example of techniques that may be included in themanufacture cup assembly140. Other techniques and combinations of techniques may be used in the manufacture ofcup assembly140.
• Modularpump coil subassembly120 can be electrically and seal tested as a standalone component. This limits manufacturing costs by detecting defective pump components before installation ofpump coil subassembly120 within a bulkhead. In addition, modularpump coil subassembly120 allows for faster assembly because potting of the pump coil occurs prior to the assembly line process, further limiting manufacturing costs by reducing the time and space required for the assembly of an IMD includingpump coil subassembly120.
• FIGS. 7-10 illustrate components of modularmedical pump200, in accordance with another example.Medical pump200 facilitates pump operation testing prior to assembling the modular medical pump in a bulkhead, i.e., testing ofmodular pump218 as a standalone component.Medical pump200 includesmodular pump218 withcover270, which includes filter element276 (FIG. 9), andbulkhead280. In many respects,medical pump200 is similar tomedical pump100. For example, many of the components described with respect tomedical pump100 are also suitable formedical pump200. These components are numbered the same inFIGS. 7-10 with respect tomedical pump200 as inFIGS. 3-6 with respect tomedical pump100. For brevity, such components are described in little, if any, detail with respect tomedical pump200.
• Likemedical pump100,medical pump200 may be part of an IMD, such as IMD12 (FIG. 1). In contrast tomedical pump100,medical pump200 includes a modular pump,modular pump218, which is mechanically and electrically functional withoutbulkhead280.Medical pump200 also includesbulkhead280.Modular pump218 includescup assembly140,coil134,barrier plate130,spring132, piston/pole subassembly160,cover270 and one-way valve152.
• As shown inFIG. 7,bulkhead280 includes cup-mountingbay282 to receivemodular pump218. In contrast to bulkhead180 (FIG. 3),bulkhead280 does not include a filter-mounting bay. Instead, cover270 ofmedical pump200 includes an integrated filter. As withbulkhead180,bulkhead280 comprises a biocompatible material. As examples,bulkhead280 may include a stainless steel alloy, a titanium alloy or other biocompatible material.
• As shown inFIG. 9, cover270 includesperforated screen274,filter element276,gasket278 andbase279.Gasket278 forms a seal betweenfilter element276 andbase279 to prevent any therapeutic fluid flowing through modular pump218 (FIG. 7) from bypassingfilter element276.Perforated screen274 serves to compressfilter element276 andgasket278 to provide a seal betweenfilter element276 andgasket278 as well as a seal betweengasket278 andbase279. As the components ofcover270 are within the flow path of fluid being pumped bymedical pump200, the components ofcover270 comprise biocompatible materials. As examples,perforated screen274 andbase279 may comprise a stainless steel, titanium alloy or other suitable material. As another example,perforated screen274 andbase279 may comprise a polymer, a stainless steel or other suitable material. In addition,gasket278 may comprise a deformable material, such as a polymer, silicon rubber or other suitable material.
• Holes273 provide the fluid flow path throughbase279. In addition,base279 includesprotrusion272, which serves constrain the motion of piston/pole subassembly160 thereby limiting the maximum stroke length of a pump stoke. As discussed with respect toprotrusions172 inmedical pump100, the height ofprotrusion272 may be selected to set the stroke length of a pump stroke ofmedical pump200.
• As best shown inFIG. 10,magnetic cup141 is separated from the flow path of fluid being pumped bymedical pump200. In the manufacture ofmodular pump218, the interior diameter ofbarrier plate130 is first sealed tosleeve144. Then, the outer diameter ofbarrier plate130 is sealed toweld ring146 to encloseelectromagnetic coil134 withinrecess149. As shown inFIG. 10,barrier plate130 is sealed tosleeve144 with a first weld joint: weld joint122, andbarrier plate130 is sealed toweld ring146 with a second weld joint: weld joint224. However, in contrast tomedical pump100, the second weld joint, weld joint224 also attachescover270 tobarrier plate130 andweld ring146. Becausecover270 is placed overbarrier plate130 prior to forming weld joint224, weld joint224 can not interfere with the placement ofcover270 againstbarrier plate130. In contrast, inmedical pump100, weld joint124 (FIG. 6) could potentially interfere with the placement ofcover270 againstbarrier plate130. The location ofcover270 is important at least becauseprotrusions272 serve to set the stroke length of a pump stroke ofmedical pump200.
• Weld ring146 forms notch147, which is adjacent to an outer perimeter ofbarrier plate130. Likewise,base279 ofcover270 forms notch281, which is adjacent to notch147 inweld ring146. Weld joint224 is partially located withinnotch147, and weld joint224 is also partially located withinnotch281. As an example, the external diameter ofbarrier plate130 may be substantially the same as the inner diameter ofnotch147 and the inner diameter ofnotch281. The combination ofbarrier plate130,sleeve144,weld ring146 andweld joints122,224 serves to fluidically separate an interior ofmagnetic cup141 from an external surface ofbarrier plate130, and thus separate the interior ofmagnetic cup141 from fluid being pumped throughmagnetic pump200. In addition,modular pump218 is installed withinbulkhead280 such thatweld ring146 is sealed to cup-mountingbay282 to fluidically separate an exterior ofmagnetic cup141 from an external surface ofbarrier plate130, and thus separate the exterior ofmagnetic cup141 from fluid being pumped throughmagnetic pump200. As examples,weld ring146 may be interference fit withinbulkhead280 within cup-mountingbay282 or sealed tobulkhead280 with a weld joint or other suitable techniques. In this manner, the design ofmedical pump200 completely separatesmagnetic cup141 from fluid being pumped throughmagnetic pump200.
• As discussed with respect tomedical pump100, the design ofmedical pump200 allows potting ofcoil134 to be performed separately from the assembly of components to bulkhead280, which streamlines the manufacture ofmedical pump200. The design ofmedical pump200 also allows seal integrity testing of weld joints122,224. Furthermore,modular pump218 can be electrically, mechanically and seal tested as a standalone component, i.e., prior to installation inbulkhead280. This additional testing further ensures the functionality of the components ofmedical pump200 prior to final assembly inbulkhead280. One additional advantage of the design ofmedical pump200 as compared tomedical pump100 is that a higher class cleanroom, i.e., a dirtier cleanroom, may be used during the assemblyprocesses including bulkhead280. For example, assembly ofmedical pump100 andmodular pump218 may be performed in an International Organization for Standardization (ISO) 14644-1 Class 5 (FED STD 209E Class 100) cleanroom, whereas assembly ofmedical pump200 may be performed in an ISO 14644-1 Class 7 (FED STD 209E Class 10,000) cleanroom.
• FIGS. 11-12B illustrate components of modularmedical pump300.Medical pump300 is substantially similar tomedical pump200, with the exception that cover370 does not include an integrated filter element. The design ofmedical pump300 facilitates pump operation testing of the modular medical pump as a standalone component, i.e., prior to assembling the modular medical pump in a bulkhead.Medical pump300 includescover370,filter element190 andbulkhead380. In many respects,medical pump300 is similar tomedical pumps100,200. For example, many of the components described with respect tomedical pumps100,200 are also suitable formedical pump300. For brevity, such components are described in little, if any, detail with respect tomedical pump300.
• Medical pump300 may be part of an IMD, such as IMD12 (FIG. 1).Medical pump300 includesmodular pump318,filter element190 andbulkhead380.Modular pump318 includescup assembly140,coil134,barrier plate130,spring132, piston/pole subassembly160,cover370 and one-way valve152.
• As shown inFIG. 11,bulkhead380 includes cup-mountingbay382 to receivemodular pump318 and filter-mountingbay384 to receivefilter190.Fluid passageway386 connects cup-mountingbay382 to filter-mountingbay384.Bulkhead380 comprises a biocompatible material. As examples,bulkhead380 may include a stainless steel alloy, a titanium alloy or other biocompatible material. Cover370 also comprises a biocompatible material such as a stainless steel, titanium alloy or other suitable material.
• In contrast to cover270 ofmodular pump218,cover370 is a unitary component.Fluid passageway374 incover370 directs fluid fromfluid passageway386 inbulkhead380 intomodular pump318. Cover370 includesprotrusion372, which serves to constrain the motion of piston/pole subassembly160 thereby limiting the maximum stroke length of a pump stoke. As discussed with respect toprotrusions172 inmedical pump100, the height ofprotrusion372 may be selected to set the stroke length of a pump stroke ofmedical pump300. Cover370 also formsnotch381, which is adjacent to notch147 inweld ring146. A weld joint sealingweld ring146, the outer diameter ofbarrier plate130, and cover370 is partially located withinnotch147 and also partially located withinnotch381. As an example, the external diameter ofbarrier plate130 may be substantially the same as the inner diameter ofnotch147 and the inner diameter ofnotch381.
• As discussed with respect tomedical pump100, the design ofmedical pump300 allows potting ofcoil134 to be performed separately from the assembly of components to bulkhead380, which streamlines the assembly ofmedical pump300. The design ofmedical pump300 also allows seal integrity testing and electrical and mechanical testing ofpump300 as a standalone component. This testing further ensures the functionality of the components ofmedical pump300 prior to final assembly inbulkhead380. In addition, as discussed with respect tomedical pump200, a higher class clean room, i.e., dirtier, may be used during assemblyprocesses including bulkhead380 than for assembly ofmodular pump318.
• FIG. 13 is a flowchart illustrating techniques for manufacturing a medical pump. For clarity, the techniques shown inFIG. 13 are described with respect tomedical pump100. Some of the assembly steps may be automated whereas other steps may be performed manually. First,magnetic cup141 andweld ring146 are assembled (402). For example,weld ring146 may be assembled tomagnetic cup141 by interference fit. Next,electromagnetic coil134 is placed withinrecess149 circumscribing protrusion145 (404).Barrier plate130 is then sealed toweld ring146 to enclose theelectromagnetic coil134 within recess149 (406), and integrity of the seals ofbarrier plate130 is tested (408). Sealingbarrier plate130 toweld ring146 and tosleeve144 fluidically separates an interior ofmagnetic cup141 from an external surface ofbarrier plate130. Next,electromagnetic coil134 is potted within magnetic cup recess149 (410). Finally, modularpump coil subassembly120 is placed within cup-mountingbay182 of bulkhead180 (412) andweld ring146 is sealed to bulkhead180 (414) to fluidically separate an exterior ofmagnetic cup141 from an external surface ofbarrier plate131.
• FIG. 14 is a flowchart illustrating techniques for manufacturing a medical pump including a pump module. For clarity, the techniques shown inFIG. 14 are described with respect tomedical pump200. First,magnetic cup141 andweld ring146 are assembled (422). For example,weld ring146 may be assembled tomagnetic cup141 by interference fit. Next,electromagnetic coil134 is placed withinrecess149 circumscribing protrusion145 (424). The inner diameter ofbarrier plate130 is then sealed tosleeve144 ofcup assembly140, e.g., with weld joint122 (426).Spring132 andpiston166 of piston/pole subassembly160 are positioned within central aperture150 (428). Cover270 is positioned overbarrier plate130 and piston/pole subassembly160. The outer diameter ofbarrier plate130 is then sealed toweld ring146 and cover270 with weld joint224 (430), and integrity of the seals ofbarrier plate130 is tested (432). In other examples, such asmedical pump500 inFIG. 16, twoseparate weld joints523,524 may be used to seal the outer diameter of abarrier plate130 to aweld ring146 and a cover570 (430). Sealingbarrier plate130 toweld ring146 and tosleeve144 fluidically separates an interior ofmagnetic cup141 from an external surface ofbarrier plate130. Next,electromagnetic coil134 is potted within recess149 (434). Optionally,modular pump218 may then be electrically, mechanically and seal tested as a standalone component. Finally,modular pump218 is mounted with cup-mountingbay282 of bulkhead280 (436), andweld ring146 is sealed tobulkhead180 to fluidically separate an exterior ofmagnetic cup141 from an external surface ofbarrier plate131.
• Medical pumps designs having a fixed stroke length, such asmedical pumps100,200,300 may be easier to manufacture and more reliable than medical pumps with adjustable stroke lengths. As referred to herein, medical pumps having a fixed stroke length, is a medical pump in which the stroke length of a piston of the pump is not adjustable in a manner that could account for variability in the manufacture of a plurality of substantially identical medical pumps, e.g., a series of medical pumps manufactured according to the same design and specifications. However, in contrast to medical pumps with adjustable stroke lengths, individual medical pumps with fixed stroke lengths can not be calibrated to account for variability in the manufacturing process to ensure that each of a plurality of substantially identical pumps provide the same volume of fluid delivered per pump stroke. As referred to in this disclosure, pumps are considered to be substantially identical pumps if built according to the same design and specifications, such as a series of pumps manufactured using interchangeable parts on the same assembly line. In some medical pump applications, such as the delivery of therapeutic fluids, the variability in volume of fluid delivered per pump stroke among a plurality of substantially identical pumps is not precise enough to provide optimal patient treatment using the medical pumps. For this reason, it may be useful to calibrate a patient therapy program to a measured volume of fluid delivered per pump stroke for the medical pump in a plurality of substantially identical pumps being controlled by the patient therapy program. In other words, a patient therapy program may be slightly adjusted to deliver desired therapy while compensating for slight differences between different substantially identical pumps.
• FIG. 15 is a flowchart illustrating techniques for delivering specified quantities of therapeutic fluid to patients using medical pumps with fixed stroke lengths. For clarity, the techniques shown inFIG. 15 are described with respect toIMD12,programmer20 andmedical pumps100,200,300.
• First, following the manufacture or assembly of a plurality of medical pumps having fixed stroke lengths, a volume of fluid delivered per pump stroke is measured for each of the medical pumps (440).Medical pumps100,200,300 are examples of medical pumps with fixed stroke lengths. In addition,pump modules218,318 are also considered medical pumps with fixed stroke lengths aspump modules218,318 provide the pumping function ofmedical pumps200,300. Measuring a volume of fluid delivered per pump stroke in a medical pump may include connecting the medical pump to a power source, pumping a fluid with the medical pump using a known number of pumping strokes, and measuring (e.g., by mass or volume) the pumped fluid to determine the volume of fluid delivered per pump stroke of the medical pump. The volume of fluid delivered may be measure automatically as part of the assembly process, or manually, either as part of the assembly process, or by a clinician prior to operation of a medical pump in conjunction with a patient.
• Indications of the measured volumes are stored in memory (442). An indication of a measured volume could be entered manually, e.g., into a user-interface ofprogrammer20 or automatically by an instrument used to measure the volumes. As examples, the memory could be included in an IMD including the medical pump, such asmemory40 inIMD12. As another example, the memory could be a memory of a programmer such asprogrammer20.
• As other examples, the memory could be a removable data storage media, such as a compact disc, memory card, magnetic disk, or the like. In some cases, the information may be stored as part of a computer database that includes indications of volumes of fluid delivered per pump stroke for plurality of substantially identical medical pumps. The stored indication of volume of fluid per pump stroke for a medical pump is stored in a manner that associates the medical pump with the stored indication. For example, the indication may be stored in a memory associated with the medical pump and/or the indication may be stored with a unique identifier, e.g., a serial number, of the medical pump to associate the medical pump with the stored indication.
• Following implantation of an IMD including the medical pump in a patient, the stored indication of volume of fluid delivered can be used to calibrate a therapy program for the delivery of a therapeutic fluid to the patient. For example, for each medical pump, a programmer, such asprogrammer20, may receive an indication of a specified quantity of therapeutic fluid to be delivered to a patient from a user (444). In different examples, the user may be the patient or a clinician. The specified quantity of therapeutic fluid may be defined as a volume, as a flow-fate, according to one or more physiological characteristics of the patient or by other means.
• Next, for each medical pump, a processor accesses the indication of volume of fluid per pump stroke for a medical pump stored in memory and generates a therapy program based on the indication of volume of fluid delivered per pump stroke and the specified quantity of therapeutic fluid to be delivered to the patient (446). The processor can be located in an IMD including the medical pump, within a programmer associated with the medical pump or within a remote device in communication withtherapy system10.
• As an example, the processor may beprocessor38 ofIMD12. In such an example,IMD12 may receive the specified quantity of therapeutic fluid to be delivered to the patient fromprogrammer20 and generate the therapy program based on the indication of volume of fluid per pump stroke automatically. Such a process may occur automatically and without the knowledge of a user who provided the specified quantity of fluid to be delivered.
• As another example, the processor may be part ofcontroller20. In such an example,controller20 may then issue instructions toIMD12 to deliver the therapeutic fluid with the equivalent quantity of pump strokes rather than directly specifying a quantity of fluid delivered in the instructions toIMD12. Again, such a process may occur automatically and without the knowledge of a user who provided the specified quantity of fluid to be delivered.
• After generation of the therapy programs, each of the medical pumps deliver a specified quantity of therapeutic fluid to a patient using a therapy program calibrated to that particular medical pump based on a volume of fluid delivered per pump stroke measured from that particular medical pump (448).
• In the manner, the specified quantities of therapeutic fluid to be delivered are converted to equivalent quantities of pump strokes based on indications of the volume of fluid delivered per pump stroke stored in a memory to account for variability in the manufacture of a plurality of substantially identical medical pumps. Generally, the techniques ofFIG. 15 are repeated for each of the plurality of substantially identical medical pumps.
• FIG. 16 illustrates components of modularmedical pump500, in accordance with another example.Medical pump500 facilitates pump operation testing of modularmedical pump518 as a standalone component, i.e., prior to assembly of modularmedical pump518 inbulkhead280. Likemedical pump200,medical pump500 may be part of an IMD, such as IMD12 (FIG. 1).Medical pump500 includesmodular pump518 andbulkhead280.Modular pump518 includescup assembly140,coil134,barrier plate530,spring132, piston/pole subassembly160,cover570 and one-way valve152.
• Medical pump500 is substantially similar tomedical pump200. One exception is that the functionality of weld joints523,524 inmedical pump200 is provided by twoseparate weld joints523,524 inmedical pump500. In addition,barrier plate530 has a smaller outer diameter thanbarrier plate530 to accommodate weld joint523, andbase579 ofcover570 includesnotch583 to accommodate weld joint523.
• Cover570 includesperforated screen274,filter element276,gasket578 andbase579.Gasket578 forms a seal betweenfilter element276 andbase579 to prevent any therapeutic fluid flowing throughmodular pump518 from bypassingfilter element276.Perforated screen274 serves to compressfilter element276 andgasket578 to provide a seal betweenfilter element276 andgasket578 as well as a seal betweengasket578 andbase579. As the components ofcover570 are within the flow path of fluid being pumped bymedical pump200, the components ofcover570 comprise biocompatible materials. As examples,perforated screen274 andbase579 may comprise a stainless steel, titanium alloy or other suitable material. As another example,perforated screen274 andbase579 may comprise a polymer, a stainless steel or other suitable material. In addition,gasket578 may comprise a deformable material, such as a polymer, silicon rubber or other suitable material.Gasket578 has a round cross-section, which in contrast to gasket278 ofcover270, which has a rectangular cross-section. However,gasket278 andgasket578 provide equivalent functionality.
• Holes573 provide the fluid flow path throughbase579. In addition,base579 includesprotrusion572, which serves constrain the motion of piston/pole subassembly160 thereby limiting the maximum stroke length of a pump stoke. As discussed with respect toprotrusions172 inmedical pump100, the height ofprotrusion572 may be selected to set the stroke length of a pump stroke ofmedical pump200.
• Magnetic cup141 is separated from the flow path of fluid being pumped bymedical pump500. In the manufacture ofmodular pump518, the interior diameter ofbarrier plate530 is first sealed tosleeve144 with weld joint122 and the outer diameter ofbarrier plate530 is sealed toweld ring146 with weld joint523 to encloseelectromagnetic coil134 withinrecess149. Then, in contrast tomedical pump200, a third weld joint, weld joint524, attachescover570 tobarrier plate530 andweld ring146. In this manner, the thickness ofbarrier plate530 does not influence the height ofprotrusion572 relative tomagnetic cup141 andweld ring146.
• Weld ring146 forms notch147, which is adjacent to an outer perimeter ofcover570. Likewise,base579 ofcover570 forms notch581, which is adjacent to notch147 inweld ring146. Weld joint524 is partially located withinnotch147, and weld joint524 is also partially located withinnotch581. In addition,base579 also forms notch583 at the inner diameter ofbase579.Notch583 is adjacent to the external diameter ofbarrier plate530. Weld joint523 is partially located withinnotch583.
• The combination ofbarrier plate530,sleeve144,weld ring146 andweld joints122,523,524 serve to fluidically separate an interior ofmagnetic cup141 from an external surface ofbarrier plate530, and thus separate the interior ofmagnetic cup141 from fluid being pumped throughmagnetic pump500. In addition,modular pump518 is installed withinbulkhead280 such thatweld ring146 is sealed to cup-mountingbay282 to fluidically separate an exterior ofmagnetic cup141 from an external surface ofbarrier plate530, and thus separate the exterior ofmagnetic cup141 from fluid being pumped throughmagnetic pump500. As examples,weld ring146 may be interference fit withinbulkhead280 within cup-mountingbay282 or sealed tobulkhead280 with a weld joint or other suitable techniques. In this manner, the design ofmedical pump500 completely separatesmagnetic cup141 from fluid being pumped throughmagnetic pump500.
• The techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the described techniques may be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit comprising hardware may also perform one or more of the techniques of this disclosure.
• Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components.
• The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer-readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.
• Various examples of the disclosure have been described. However, modifications to the described examples may be made within the spirit of the disclosure. As an example, the described examples generally referred to medical pumps as delivering a therapeutic fluid to a target site within a patient. However, medical pumps may also be used to remove fluid from a patient. Specific examples of draining include using medical pumps to drain cerebrospinal fluid (CSF) from a patient and using medical pumps to drain other fluids from a cavity within a patient. These and other examples are within the scope of the following claims.

Claims (23)

1. An implantable medical device comprising:

a fluid reservoir configured to store a therapeutic agent;

a port configured to deliver the therapeutic agent to a patient;

a medical pump subassembly configured to actively transfer the therapeutic fluid from the fluid reservoir to the port; and

a housing that contains the fluid reservoir, the port and the medical pump subassembly,

wherein the medical pump subassembly is configured to facilitate mechanical and electrical testing of the medical pump subassembly as a standalone component.

2. The implantable medical device ofclaim 1, wherein the medical pump subassembly is configured to facilitate weld integrity testing of the medical pump subassembly as the standalone component.

3. The implantable medical device ofclaim 1, wherein the medical pump subassembly is configured to facilitate fluid seal testing of the medical pump subassembly as the standalone component.

4. The implantable medical device ofclaim 1, wherein the medical pump subassembly is configured to facilitate mechanical testing of the medical pump subassembly as the standalone component to measure a volume of fluid delivered per pump stroke of the medical pump subassembly.

5. The implantable medical device ofclaim 1, further comprising a bulkhead including a bay that receives the medical pump subassembly, wherein the bulkhead provides at least a portion of the housing.

6. The implantable medical device ofclaim 1, wherein the medical pump subassembly comprises:

a magnetic cup forming a recess, wherein the magnetic cup includes a protrusion within the recess, wherein the cup forms a central aperture through the protrusion;

an electromagnetic coil within the recess and circumscribing the protrusion;

a weld ring surrounding the recess;

a barrier plate covering the recess; and

a weld between the weld ring and the barrier plate to fluidically separate an interior of the cup from an external surface of the barrier plate.

7. The implantable medical device ofclaim 6, wherein the weld is a first weld, the subassembly further comprising:

a sleeve within the central aperture, wherein the barrier plate forms a mating aperture that coincides with the central aperture of the cup; and

a second weld between the sleeve and the barrier plate at an internal diameter of the barrier plate to fluidically separate the interior of the cup from the external surface of the barrier plate.

8. The implantable medical device ofclaim 7, wherein the medical pump subassembly comprises:

an electromagnetic drive coil including a magnetic cup;

a barrier plate over the electromagnetic drive coil;

a cover; and

a third weld between the cover and the barrier plate at an external diameter of the barrier plate.

9. The implantable medical device ofclaim 1, wherein the medical pump subassembly comprises:

an electromagnetic drive coil including a magnetic cup;

a barrier plate over the electromagnetic drive coil; and

a cover.

10. The implantable medical device ofclaim 9, further comprising a weld joint between the magnetic cup, the barrier plate and the cover.

11. The implantable medical device ofclaim 1, further comprising a refill port in fluidic communication with the fluid reservoir.

12. The implantable medical device ofclaim 1, wherein the medical pump subassembly comprises:

a magnetic cup forming a recess, wherein the magnetic cup includes a protrusion within the recess, wherein the cup forms a central aperture through the protrusion;

a one-way valve that controls fluid flow within the central aperture;

an electromagnetic coil within the recess and circumscribing the protrusion;

a barrier plate covering the recess;

a piston within the central aperture;

a magnetic pole attached to the piston, wherein the magnetic pole is adjacent to an external surface of the barrier plate;

a cover enclosing the magnetic pole between an interior surface of the cover and an external surface of the barrier plate, wherein the cover constrains the motion of the piston within the central aperture; and

a weld between the cup and the barrier plate and the cover to fluidically separate an interior of the cup from the external surface of the barrier plate.

13. A method of manufacturing a medical pump comprising:

obtaining a medical pump subassembly;

mechanically and electrically testing of the medical pump subassembly as a standalone component; and

installing the medical pump subassembly within a housing of an implantable medical device, the implantable medical device including:

a fluid reservoir configured to store a therapeutic agent;

a port configured to deliver the therapeutic agent to a patient;

the medical pump subassembly; and

the housing, wherein the housing is configured to contain the fluid reservoir, the port and the medical pump subassembly.

14. The method ofclaim 13, further comprising performing weld integrity testing of the medical pump subassembly as the standalone component prior to installing the medical pump subassembly within the housing of the implantable medical device.

15. The method ofclaim 13, further comprising performing fluid seal testing of the medical pump subassembly as the standalone component prior to installing the medical pump subassembly within the housing of the implantable medical device.

16. The method ofclaim 13, further comprising performing mechanical testing of the medical pump subassembly as the standalone component to measure a volume of fluid delivered per pump stroke of the medical pump subassembly prior to installing the medical pump subassembly within the housing of the implantable medical device.

17. The method ofclaim 16, further comprising storing an indication of the volume of fluid delivered per pump stroke in a memory.

18. The method ofclaim 17, further comprising delivering a specified quantity of therapeutic fluid to the patient based on the indication of the volume of fluid delivered per pump stroke.

19. The method ofclaim 16, further comprising storing an indication of the volume of fluid delivered per pump stroke in a memory of the implantable medical device.

20. The methodclaim 13,

wherein the implantable medical device includes a bulkhead including a bay configured to receive the medical pump subassembly,

wherein the bulkhead provides at least a portion of the housing,

wherein installing the medical pump subassembly within the housing of the implantable medical device comprises positioning the medical pump subassembly within the bay.

21. The methodclaim 13, wherein obtaining the medical pump subassembly comprises:

placing an electromagnetic coil within a recess of a magnetic cup and circumscribing a protrusion in the magnetic cup, wherein the a protrusion is within the recess, wherein the magnetic cup forms a central aperture through the protrusion, and wherein the magnetic cup is included in a magnetic cup/weld ring assembly also including a weld ring surrounding the recess;

welding a barrier plate to the weld ring to enclose the electromagnetic coil within the recess to fluidically separate an interior of the cup from an external surface of the barrier plate; and

potting the electromagnetic coil within the recess after welding the barrier plate to the weld ring to create a potted magnetic cup/electromagnetic coil assembly.

22. The methodclaim 21, wherein obtaining the medical pump subassembly further comprises:

placing the potted magnetic cup/electromagnetic coil assembly within a cup-mounting bay of a bulkhead; and

welding the weld ring to the bulkhead to fluidically separate an exterior of the cup from an external surface of the barrier plate.

23. The methodclaim 21, wherein obtaining the medical pump subassembly further comprises:

positioning a piston of a piston/pole subassembly within the central aperture;

positioning a cover configured to mate with the weld ring to enclose the magnetic pole between an interior surface of the cover and an external surface of the barrier plate; and

welding the cover to the weld ring.

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