Patent Application
20210338929
The present disclosure relates generally to implantable medical devices, and more particularly to a system and method configured to provide feedback to a user when refilling of a fluid reservoir of an implantable medical device with medicament.
A variety of medical devices are used for chronic or long-term delivery of therapy to patients suffering from a variety of conditions, such as chronic pain, tremor, Parkinson's disease, cancer, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, spasticity, or gastroparesis. For example, pumps or other fluid delivery devices can be used for chronic delivery of therapeutic medicaments, such as drugs or other agents. Typically, such devices provide therapy continuously or periodically according to programmed parameters. The programmed parameters can specify the therapeutic regimen (e.g., the rate, quantity, and timing of medicament delivery to a patient), as well as other functions of the medical device.
Implantable medical infusion pumps have important advantages over other forms of medicament administration. For example, oral administration is often difficult because the systematic dose of the substance needed to achieve the therapeutic dose at the target site may be too large for the patient to tolerate without adverse side effects. Also, some substances simply cannot be absorbed in the stomach adequately for a therapeutic dose to reach the target site. Moreover, substances that are not lipid soluble may not cross the blood-brain barrier adequately if needed in the brain. In addition, infusion of substances from outside the body requires a transcutaneous catheter, which results in other risks such as infection or catheter dislodgment. Further, implantable medical pumps avoid the problem of patient noncompliance of the patient failing to take the prescribed drug or therapy as instructed.
Implantable medical infusion pumps are typically implanted at a location within the body of a patient (typically a subcutaneous region in the lower abdomen) and are configured to deliver a fluid medicament through a catheter. The catheter is generally configured as a flexible tube with a lumen running the length of the catheter to a selected delivery site in the body, such as the intracranial or subarachnoid space.
Various types of implantable medical pumps are in use for dispensing medication within the body. These devices either have reservoirs which are to be filled for dispensation on a time-release basis, such as an implantable drug dispenser, or have ports for insertion of medication that is dispensed through an implantable catheter, commonly known as an access port. In these devices, the reservoir for receiving medication is commonly sealed with a pierceable septum. A hypodermic needle is inserted through the skin and through the access port and the septum into the reservoir. Once within the reservoir, the medication is dispensed from the syringe.
It is critical to the performance of the refilling process that the needle tip is properly positioned at the desired dispensing location. If the needle is outside the device, medication will be improperly dispensed into the body. This could lead to a fatal or otherwise harmful dose of medicament being injected directly into a subcutaneous pocket surrounding the implantable pump. If the needle opening is within the septum, rather than through the septum, excess pressure in the syringe may be required to dispense medication or the dispensing within the reservoir may be entirely prevented and be improperly dispensed into the body. However, access to the refill port with the needle tip cannot be performed with the benefit of direct visualization because the pump is implanted under the skin of the patient.
Embodiments of the present disclosure provide a system and method configured to provide confirmation to a user that a needle has entered a refill port during a refill procedure for an implantable medical device through the use of a resilient tactile feedback element within the refill port chamber that provides tactile feedback to a user of the refill needle of a location of the needle within the refill port.
In an embodiment, an implantable medical pump includes a pump housing configured to be percutaneously implanted into a patient and a medicament reservoir contained within the housing configured to contain a medicament to be delivered to the patient. A refill port can be disposed on an exterior surface of the pump housing to provide percutaneous access to a needle to refill the medicament reservoir with the medicament via a refill port cavity in fluid communication with the medicament reservoir. A needle guide can be disposed and movable within the refill port chamber and a resilient member can be disposed distally of the needle guide in the refill port chamber. The needle guide can be configured to move distally under force of the needle to contact the resilient member to actuate the resilient member from a rest position to provide tactile feedback to the user of the location of the needle within the refill port chamber. The needle guide can also function to protect the resilient member from damage that could be caused by direct contact with the needle as well as to center the contact with resilient member at a center of the resilient member.
In an embodiment, a refill port providing percutaneous access to a needle to refill a medicament reservoir of an implantable medical pump can include a refill port cavity in fluid communication with the medicament reservoir and a septum providing a needle access to the refill port cavity. A needle guide can be disposed and movable within the refill port chamber and a resilient member can be disposed distally of the needle guide in the refill port chamber. The needle guide can be configured to move distally under force of a needle to contact the resilient member to actuate the resilient member from a rest position to provide tactile feedback to the user of the location of the needle within the refill port chamber. The needle guide can also function to protect the resilient member from damage that could be caused by direct contact with the needle as well as to center the contact with resilient member at a center of the resilient member.
The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:
While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
Referring to
Referring to
The electronic components 120 can include a processor 124, memory 126/127, and transceiver circuitry 128 that can interface with one or more control registers 125. In one embodiment, the processor 124 can be an Application-Specific Integrated Circuit (ASIC) state machine, gate array, controller, microprocessor, CPU, or the like. The electronic components 120 can be generally configured to control infusion of medicament according to programmed parameters or a specified treatment protocol. The programmed parameters or specified treatment protocol can be stored in the memory 126. The transceiver circuitry 128 can be configured to receive information from and transmit information to the external programmer 108 and/or server 110. In one embodiment, the electronic components 120 can be further be configured to operate a number of other features, such as, for example, a patient alarm 130 operable with an internal clock and/or calendar 131 and an alarm drive 129.
The implantable medical pump 102 can be configured to receive programmed parameters and other updates from the external programmer 108, which can communicate with the implantable medical pump 102 through well-known techniques such as wireless telemetry. In some embodiments, the external programmer 108 can be configured for exclusive communication with one or more implantable medical pumps 102. In other embodiments, the external programmer 108 can be any computing platform, such as a mobile phone or tablet. In some embodiments, the implantable medical pump 102 and external programmer 108 can further be in communication with a cloud-based server 110. The server 110 can be configured to receive, store and transmit information, such as program parameters, treatment protocols, drug libraries, and patient information, as well as to receive and store data recorded by the implantable medical pump 102. In some embodiments, pump 102 may provide tactile feedback to the user of the location of a needle as described in this disclosure.
Referring now to
Needle guide 140 functions to both center the actuation of the resilient dome 138 at the center of the dome and to protect the resilient material of the dome from direct needle 10 contact. Needle guide 140 includes a sloped annular surface 147 that guides a needle 10 that enters the refill port cavity 136 misaligned down to the flat bottom surface of the needle guide. Needle guide 140 can be comprised of a material that can withstand repeated needle contact, such as, for example, a metal material including, e.g., stainless steel, titanium, tantalum, MP35N®, Elgiloy® or Beta21S, among others. Needle guide 140 can translate up and down within the refill port cavity 136 when actuated by the needle 10. In embodiments, needle guide 140 can be generally free floating within refill port cavity 136 but be radially constrained with a body 146 sized to fit within refill port cavity 136 to prevent the needle guide 140 from tilting when moving within the cavity. Needle guide 140 can also be axially restrained from moving up to contact the refill septum 134 by annular rim 135 within refill port cavity 136 that blocks the needle guide 140 from moving axially past the annular rim 135. Needle guide 140 further provides space for fluid to flow between the needle guide and the refill port such that medicament does not get trapped within port.
Use of a needle guide 140 such as that described above also enables use of additional resilient members that can provide tactile response to insertion of the needle that, in some embodiments, may not have been useable with a needle alone without such a needle guide 140. For example,
In other embodiments depicted in
A refill port 132 that utilizes a stamped spring 158 as a resilient tactile feedback element is depicted in
Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.
