Abstract:
Disclosed is a universal connector for connecting component devices of an implantable medical treatment system. The universal connector includes a male and a female interface adapted to connectively mate two devices of the implantable medical treatment system. A locking flange and recess are provided, as well as a locking shoulder and ridge combination, to securely connect the mated male and female interfaces. When mated and securely joined, the universal connector of the present invention allows a device of the implantable medical treatment system to interface with any other device of the implantable medical treatment system for simplified handling and bi-directional communications.

Description:
FIELD OF THE INVENTION 
   The present invention generally relates to implantable medical device systems. More particularly, this invention relates to uniform interfaces for connecting component devices of an implantable medical treatment system, including telemetry modules of wired or wireless physician/patient programmers, magnet housings, external neural stimulators, patient chargers, and various other programming system component devices. 
   BACKGROUND OF THE INVENTION 
   The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Physicians use medical devices alone or in combination with drug therapies to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life. 
   Implantable medical devices are commonly used today to treat patients suffering from various ailments. Implantable medical devices can be used to treat any number of conditions such as pain, incontinence, movement disorders such as epilepsy and Parkinson&#39;s disease, and sleep apnea. Additional therapies appear promising to treat a variety of physiological, psychological, and emotional conditions. As the number of implantable medical device therapies has expanded, greater demands have been placed on the implantable medical device. 
   These devices provide treatment therapy by delivering electrical stimulation or drugs to various portions of the body and include, for example without limitation, neurostimulators, drug delivery devices, pacemakers, defibrillators, and cochlear implants. In the case of providing electrical stimulation, one or more electrodes are implanted within the body. A physician uses an external neural stimulator (ENS) connected to provide electrical energy to the electrodes and establish effective treatment parameters. Once efficacious treatment settings have been determined, an implantable neurostimulator (INS) (also known as an Implantable Pulse Generator (IPG)) replaces the ENS, is connected to the electrodes, and is implanted within the patient&#39;s body. In the case of providing drugs, a pump is implanted within the body. The pump is coupled to a catheter that delivers drugs to select portions of the body. Patients can be implanted with both INS and pump devices, or combination devices. INS and pump devices can be programmed and recharged while implanted within a patient to adjust treatment therapies over time without invasive surgery. 
   A physician programmer, typically a computer with associated electronics, can communicate with the ENS, INS, and pump devices using telemetry. A telemetry module is linked to the physician programmer with a cable or by wireless methods. A patient programmer and a patient charger can also communicate with implanted treatment devices, as well as with the physician programmer, via wired or wireless links. The physician or patient may want devices of the treatment system to communicate with one another via telemetry for any number of reasons including, for example, to recharge a power supply of the implanted device, to fine tune the therapy program, to exchange diagnostic data between devices, to account for changes in the disease being treated, or to account for migration of the implanted lead or catheter. 
   Known systems for programming a medical device have a number of disadvantages. In particular, many implanted pumps must be activated for programming by the presence of a strong magnet. Such a magnet is typically built into the telemetry module used to program the pump. In contrast, an INS is sometimes activated or deactivated by a strong magnet and therefore, a single telemetry module could not be used to communicate with both an INS and an implantable pump. In another example of known limitations, a physician programmer, patient programmer, ENS, patient charger, and other component devices of the telemetry programming system could not be uniformly connected to communicate with one another via telemetry. This limitation is especially problematic because telemetrically communicating devices must be held in close proximity to one another, and handling multiple devices during medical treatment is cumbersome. In yet another example, when the power supply of the implanted device needs to be recharged, the patient must physically hold the telemetry module close to his/her body. This can be of great inconvenience when it takes on the order of hours to fully recharge the power supply. These limitations required physicians and patients to use multiple programming devices, thereby increasing the cost, time, and complexity of handling and operating the various component devices of an implantable medical treatment system. 
   BRIEF SUMMARY OF THE INVENTION 
   The universal connector of the present invention allows component devices of a programming system to be efficiently and securely connected to one another. In an exemplary embodiment, a female interface of the universal connector is included on the telemetry module of a hand-held physician programmer. Correspondingly, a male interface of the universal connector is included on a hand-held patient programmer, on a magnet housing, on an ENS, on a patient charger, and on any other device of the programming system that is advantageously connected to the telemetry module of the physician programmer. By mating the male interface to the female interface, two devices of the programming system can be securely connected together. It is not critical to the invention which device carries the male or female interface, so long as the two devices to be connected carry different, interlocking interfaces. Thus, for example, a magnet housing having a male interface connector can be connected to a telemetry module for programming an implanted pump, and the magnet can be removed when the same telemetry module is used to program an INS. Likewise, the same telemetry module can be directly connected to a patient programmer or to an ENS. 
   The universal connector of the present invention is easy to operate, provides visual cues about its operation, and produces positive tactile feedback when a secure connection is achieved. The connector is durable and compact, allowing a single telemetry module design to connect with any other element of the programming system. The universal connector of the present invention thus allows a telemetry module to interface with any number of devices and accomplish the objectives of previously separate units. Furthermore, the connector of the present invention insures that communicating devices will be securely held in proximity to one another for effective telemetry. Advantageously, patient and physician only need to use one programming device. In addition, the connector of the present invention allows components to be more conveniently handled, effectively allowing a user to hold two component devices in one hand, freeing the other hand for other activities such as using the programmer, writing, or attending to the patient, among others. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     These and other advantages and features of the invention will become apparent upon reading the following detailed description and referring to the accompanying drawings in which like numbers refer to like parts throughout and in which: 
       FIG. 1A  is a representation of an implanted medical pump in relation to a hand-held physician programmer and a patient programmer. 
       FIG. 1B  is a representation of an INS in relation to a hand-held physician programmer and an ENS. 
       FIG. 2A  is a front side view of a male connector interface of the present invention mounted to a magnet housing used in programming an implanted medical pump. 
       FIG. 2B  is a frontal view of the male connector interface of  FIG. 2A . 
       FIG. 2C  is a front side view of the male connector interface of  FIG. 2A  rotated 90-degrees. 
       FIG. 2D  is a back view of the magnet housing of  FIGS. 2A–2C . 
       FIG. 3A  is a cross-sectional view of the male interface connector of  FIG. 2B  taken along line B—B. 
       FIG. 3B  is an enlarged, partial, cross-sectional view of the male interface connector of  FIG. 3A . 
       FIG. 3C  is a cross-sectional view of the male interface connector of  FIG. 2B  taken along line C—C. 
       FIG. 4A  is a front side view of a female connector interface of the present invention mounted to a surface of a telemetry module used to communicate with other component devices of an implantable medical treatment system. 
       FIG. 4B  is a front view of the female connector interface of  FIG. 4A . 
       FIG. 4C  is a partial, side, cross-sectional view of the female connector interface of  FIG. 4B  taken along line C—C. 
       FIG. 4D  is an enlarged, partial, cross-sectional view of the female interface connector of  FIG. 4C . 
       FIG. 5A  is a front side view of a magnet housing connected to a telemetry module via the uniform interface of the present invention. 
       FIG. 5B  is a side view of  FIG. 5A . 
       FIG. 6A  is a side view of an external neural stimulator connected to a telemetry module via the uniform connector of the present invention. 
       FIG. 6B  is a front side view of  FIG. 6A . 
       FIG. 7  is a back side view of a magnet housing connected to a telemetry module via the uniform interface of the present invention, where the telemetry module is cradled in a physician programmer. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1A  illustrates the relationship between physician programmer  600 , patient programmer  50 , and implanted pump  10  in accordance with one embodiment of the present invention. As shown, telemetry module  330  is linked to physician programmer  600  through cable  30 , although one skilled in the art will appreciate that telemetry module  330  can be designed to communicate with physician programmer  600  by wired or wireless methods. Patient programmer  50  and physician programmer  600  can advantageously communicate with one another via telemetry. Likewise, patient programmer  50  and physician programmer  600  can communicate with implanted pump  10  via telemetry. As shown, implanted pump  10  is connected to catheter  15  and may be used to deliver a treatment drug, held in a reservoir within the pump, to a target area of a patient&#39;s body. A physician or patient may wish to establish bi-directional links between the treatment devices for any number of reasons, including to exchange data, to adjust therapy programs, or to recharge the implanted pump. As one skilled in the art will recognize, it would be advantageous to uniformly connect telemetry head  330  to a magnet to facilitate communications with an implanted pump, or to connect telemetry head  330  directly to patient programmer  50 . Also, attaching a magnet to telemetry head  330  allows the telemetry head to be held in place against a patient&#39;s skin by magnetic attraction to pump  10  during lengthy programming or charging sessions. 
     FIG. 1B  illustrates the relationship between physician programmer  600 , ENS  500 , and INS  20  in accordance with another embodiment of the present invention. One or more electrical leads  25  are implanted within a patient, for example, to electrically stimulate regions of the spinal cord and thereby relieve pain. A physician uses ENS  500 , connected to leads  25 , to determine an efficacious treatment therapy. Once a therapy is established, ENS  500  is disconnected, and INS  20  is connected to leads  25  and implanted within the body. As one skilled in the art will recognize, it would be advantageous to be able to uniformly connect telemetry head  330  to ENS  500  to facilitate programming and communications between the devices. Likewise, it would be advantageous to be able to communicate with INS  20  using the same telemetry module used to program an implanted pump like pump  10  shown in  FIG. 1A , without a magnet attachment connected to the telemetry module. 
   The uniform connector of the present invention allows the various component devices of the programming system of  FIGS. 1A and 1B  to be advantageously connected. Those skilled in the art will appreciate, however, that the present invention can be used in conjunction with any implanted medical devices, including, for example without limitation, neurostimulators, drug delivery devices, pacemakers, defibrillators, and cochlear implants, and that  FIGS. 1A and 1B  serve merely as examples of how the present invention can be used.  FIGS. 2A–C  illustrate male connector interface  100 , including at least one interface flange  110 A and  110 B. Male connector interface  100  further includes bearing surface  115 . Male interface  100  is shown on magnet housing  120 . Although  FIGS. 2A–C  show male interface  100  in relation to magnet housing  120 , interface  100  can be used in relation to any other device of the programming system so long as the two devices to be connected carry different, interlocking interfaces, i.e., one male, one female.  FIG. 2D  illustrates the reverse side of magnet housing  120 , which is brought into contact with a patient&#39;s skin or clothing. 
     FIG. 3A  illustrates a cross-section view of male connector interface  100  taken along line A—A of  FIG. 2B .  FIG. 3B  shows a detail of  FIG. 3A . In  FIGS. 3A and 3B , Male interface  100  is shown protruding from magnet housing  120  on shaft  200 . The shaft  200  of male connector interface  100  allows flanges  110 A and  110 B to be inserted into female interface  300 , described below. Flanges  110 A and  110 B further include at least one shoulder  210 A and  210 B. As described further below, shoulders  210 A and  210 B lockingly engage female interface  300  and provide a tactile indication when a secure connection between the male and female interfaces has been achieved. By tensioning the interface of male interface  100  and female interface  300 , bearing surface  115  works in conjunction with shoulders  210 A and  210 B to insure a positive tactile indication when a secure connection is achieved. Bearing surface  115  further provides a smooth surface on which male interface  100  can rotate within female interface  300 , as described below. 
     FIG. 3C  illustrates a cross-section of male connector interface  100  taken along line B—B of  FIG. 2B . Referring now to  FIGS. 3A–3C  as a group, shoulder  210 A is shown generally centered on flange  110 A and abutting shaft  200 . Magnet housing  120  includes magnet receptacle  130  wherein a magnet (not shown) can be enclosed to create a magnetic field around the magnet housing. In practice, housing  120  contains a magnet capable of interacting with an implantable pump such as the device shown in U.S. Pat. No. 4,692,147 (Duggan), assigned to Medtronic, Inc., Minneapolis, Minn., and commercially available as the Synchromed infusion pump, both of which are incorporated by reference. Housing  120  is connected to a telemetry module of a physician programmer through the mating of male connector interface  100  and female connector interface  300 , described below. When housing  120  is moved near to a patient&#39;s implanted pump, the pump is activated for programming in response to the magnetic field generated by the magnet enclosed within housing  120  and telemetry can be initiated. Further, the magnetic attraction between the magnet of housing  120  and a magnet of an implanted pump holds telemetry head  330  of  FIG. 1A  in place while the physician programmer is communicating with the implanted pump. In this way, the physician or patient is freed from having to hold the telemetry head in place during lengthy programming or recharging sessions. 
     FIGS. 4A and 4B  illustrate female connector interface  300 , including at least one overhanging recess  310 A and  310 B and at least one locking ridge  320 A and  320 B thereupon. When connected, shaft  200  of male interface  100  is inserted into depth  340  of female interface  300 . Magnet housing  120  is turned to rotate male interface  100  90-degrees in either direction and thereby slide interface flanges  110 A and  110 B into recesses  310 A and  310 B. Bearing surface  115  on male interface  100  (shown in  FIGS. 2A–2C ) and close tolerances allow for a secure and reliable fit. Male interface  100  is thereby connectively mated to female interface  300 . Although shown on telemetry module  330 , female interface  300  can be used in relation to any other device of the programming system so long as the two devices to be connected carry different, interlocking interfaces, i.e., one male, one female. 
     FIG. 4C  illustrates a cross-section of female interface  300  taken along line C—C of  FIG. 4B .  FIG. 4D  shows a detail of  FIG. 4C . As seen in  FIGS. 4C and 4D , locking ridge  320 A consists of at least two peaks  322 A,  324 A, and valley  326 A. Although not shown in this cross-section, locking ridge  320 B includes similar peaks  322 B,  324 B, and valley  326 B. Referring now to  FIGS. 2A–4D  as a group, in practice, shoulders  210 A and  210 B engage the peaks and valleys of locking ridge  320 A and  320 B when male interface  100  is rotated to slide interface flanges  110 A and  110 B within recesses  310 A and  310 B. The interaction of shoulders  210 A and  210 B with locking ridges  320 A and  320 B, in conjunction with bearing surface  115 , provides a locking stop position in the rotation of shaft  200  and a tactile indication to a user that male interface  100  has securely engaged female interface  300 . In this way, any variety and combination of component devices of an implantable medical device programming system, including but not limited to a telemetry module of a physician programmer, a patient programmer, an ENS, a magnet housing, or a patient charger, can be securely connected to one another, so long as the two devices to be connected carry different, interlocking interfaces, i.e., one male and one female. 
     FIGS. 5A and 5B  illustrate a magnet housing  120  connected to telemetry module  330  via the uniform connector interface of the present invention. In this configuration, telemetry module  330  can be used to program an implanted pump. Alternatively, magnet housing  120  can be removed, and telemetry module  330  can be used to program an INS. 
     FIGS. 6A and 6B  illustrate a telemetry module  330  connected to an ENS unit  500  via the uniform connector interface of the present invention. In this configuration, a bi-directional communications link exists between the telemetry module  330  and the ENS  500  to enable a physician programmer like physician programmer  600  shown in  FIG. 1B  to program the ENS with treatment parameters via the bi-directional communications link. The treatment parameters may be provided singly or in a batch, or the parameters may be provided one at a time in a real-time interactive mode. The physician programmer may also upgrade software or operating system of the ENS  500  via this bi-directional communications link. The ENS  500  may also provide certain diagnostic information back to the physician programmer including, for example, parameter settings (e.g., stimulation frequency, stimulation pulse amplitude, stimulation pulse width, electrode configuration, etc.), patient diagnostic data (e.g., usage data), system diagnostic data (e.g., battery status, estimated longevity of implanted device, lead system integrity, load impedance, etc.), data on device usage, data regarding the last programmer/ENS session, the state of the device, configuration of an INS (e.g., simple or complex patient user interface), whether a valid communication channel exists, and the like. 
     FIG. 7  illustrates magnet housing  120  connected to telemetry module  330  via the uniform connector interface of the present invention, and where telemetry module  330  is docked to physician programmer  600 . 
   Referring now to  FIGS. 1A ,  1 B, and  5 A– 7  as a group, it is apparent that other component devices of the implantable medical treatment system can be connected via the uniform connector interface of the present invention. For example, a patient programmer, patient charger, or even other telemetry modules can be connected to telemetry module  330  so long as each device to be connected includes a different uniform connector interface, i.e., one male and one female. In this way, a single physician programmer can securely connect to any other device of the system and exchange any manner of information via a bi-directional communications link. Among other advantages, the connected devices can be easily handled as one device and are securely placed in close proximity to one another for effective telemetry.