Electrically detachable temporary cardiac pacing wire system

Abstract

A temporary cardiac pacing system includes a temporary cardiac pacing wire having a distal portion and a proximal portion connected to one another via a releasable electrical connection. An electrode of the distal portion is configured to be implanted in a cardiac tissue. The proximal portion is configured to extend through a skin to an exterior of a patient body to be coupled to an external pacemaker device. The releasable electrical connection is configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body with negligible force.

Description

Attorney Docket No. 50124 / 10302 (EST01-02PCT)ELECTRICALLY DETACHABLE TEMPORARY CARDIAC PACING WIRE SYSTEM Inventors: Hector GARCIA ESTRADA, Nader MO AZAMI, Mladen BARBIC, Akshay KUMAR, and Tajinderpal SARAONPRIORITY CLAIM

[0001] The present application claims priority to U.S. Provisional Patent Application Serial No. 63 / 693,954 fded on September 12, 2024, the entire disclosure of which is incorporated herein by reference.BACKGROUND

[0002] There are approximately 500,000 open heart surgeries performed in the United States alone each year. A majority of these surgeries (80-90%) require temporary pacing wires (i.e., epicardial pacing wires) to maintain an appropriate heart rate in the immediate postoperative period. According to some current temporary pacing wire placement techniques, a distal end of the wire is embedded in the epicardium of the heart and secured therein by suturing a portion of the wire to an exterior surface of the heart.

[0003] A remaining length of the wire is pierced through the skin to be coupled to an external pacemaker. These wires may remain in the body for approximately 7-10 days until they are removed. To remove the wire, a surgeon or other medical professional must manually pull the wire from the heart tissue, from an exterior of the patient body, which may result in a tear and / or bleeding complications requiring emergency surgery. In some circumstances in which the tear / bleed goes unnoticed, it may result in death. In other situations, a surgeon may opt to leave the wire in the patient body due to concerns over bleeding. In these cases, the wire may be clipped and left to retract into the skin.SUMMARY

[0004] The present disclosure relates to a temporary cardiac pacing system. The temporary cardiac pacing wire includes a distal portion and a proximal portion connected to one another via a releasable electrical connection. An electrode of the distal portion is configured to be implanted in a cardiac tissue and the proximal portion is configured to extend through a skin toAttorney Docket No. 50124 / 10302 (EST01-02PCT) an exterior of a patient body to be coupled to an external pacemaker device. The releasable electrical connection is configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body with negligible force.

[0005] In an embodiment, the distal portion extends longitudinally from a proximal end to a distal end, a segment of the distal portion covered via a non-conductive material such that the distal and proximal ends of the distal portion remain exposed, the exposed distal end of the distal portion defining the electrode.

[0006] In an embodiment, the proximal portion extends longitudinally from a proximal end to a distal end, a segment of the proximal portion covered via a non-conductive material such that distal end of the proximal portion remains exposed.

[0007] In an embodiment, the proximal end of the proximal portion includes a needle configured to pierce through the skin.

[0008] In an embodiment, the releasable electrical connection is formed via contact between the exposed distal end of the proximal portion and the exposed proximal end of the distal portion.

[0009] In an embodiment, the releasable electrical connection further includes a low melting point phase change material encasing the exposed distal end of the proximal portion and the exposed proximal end of the distal portion in contact with one another, the low melting point phase change material configured to melt when subject to a heat energy exceeding the predetermined threshold value.

[0010] In an embodiment, the temporary cardiac pacing system further comprises a heating element configured to extend about the low melting phase change material to deliver a heat energy configured to release the releasable electrical connection.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0011] In an embodiment, the low melting point phase change material includes one of a wax, thermoplastic polymer, and a metal such as, for example, Gallium or Shape Memory Alloy Nitinol.

[0012] In an embodiment, the temporary cardiac pacing system further comprises an insulating tubing extending about the heating element and the releasable electrical connection to protect a surrounding tissue from the heat energy.

[0013] In an embodiment, the temporary cardiac pacing system further comprises a temperature sensor configured to detect when the low melting temperature phase change material has melted to release the releasable electrical connection.

[0014] In an embodiment, a signal from the temperature sensor is transmitted as a feedback signal to a controller configured to control a current supplied to the heating element based on the feedback signal to optimize a release of the releasable electrical connection and reduce risk of overheating.

[0015] In an embodiment, the releasable electrical connection is spring-loaded to facilitate detachment of the proximal portion from the distal portion.

[0016] The present disclosure also relates to a temporary cardiac pacing wire comprising a distal portion, a proximal portion, and a releasable connection. The distal portion extends longitudinally from a proximal end to a distal end includes an electrode configured to be implanted into a cardiac tissue to provide cardiac pacing thereto. The proximal portion extends longitudinally from a proximal end to a distal end and is configured to be inserted through a skin to an exterior of a patient body to be coupled to an external pacemaker device. The releasable connection connects the proximal end of the distal portion and the distal end of the proximal portion in electrical contact with one another. The releasable connection is configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body via a negligible force.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0017] In an embodiment, the releasable connection includes a low melting point phase change material which holds the distal and proximal portions in electrical contact with one another when in a first phase and releases the connection between the distal and proximal portions in a second phase, the low melting point phase change material transitioning from the first phase to the second phase when subject to a heat energy exceeding the predetermined threshold value.

[0018] In an embodiment, the temporary cardiac pacing wire further comprises a heating element extending about the releasable connection to deliver a heat energy configured to release the releasable connection.

[0019] In an embodiment, the temporary cardiac pacing wire further comprises an insulating tube extending about the heating element to protect a surrounding tissue from the heat energy.

[0020] In an embodiment, a segment of the distal portion is covered via a non-conductive material such that the distal and proximal ends of the distal portion remain exposed, the exposed distal end of the distal portion defining the electrode.

[0021] In an embodiment, a segment of the proximal portion is covered via a non-conductive material such that distal end of the proximal portion remains exposed.

[0022] The present disclosure also relates to a method for providing temporary cardiac pacing. The method includes implanting an electrode along a distal portion of a temporary pacing wire in a cardiac tissue; suturing a portion of the distal portion proximal of the electrode to an exterior surface of the cardiac tissue to secure the electrode therein; passing a proximal portion of the temporary pacing wire through a skin to an exterior of a body of a patient to couple a proximal end of the proximal portion to an external pacemaker device, the proximal portion connected to the distal portion via a releasable electrical connection; providing one of a monitoring and a pacing of a heart of the patient via the temporary cardiac pacing wire for a desired period of time; applying an energy to the releasable electrical connection to release theAttorney Docket No. 50124 / 10302 (EST01-02PCT) electrical connection; and detaching the proximal portion from the distal portion with negligible force so that the proximal portion is removable from the body while the distal portion remains securely attached to the cardiac tissue.

[0023] In an embodiment, the releasable electrical connection includes a low melting point phase change material which holds a proximal end of the distal portion and a distal end of the proximal portion in electrical contact with one another so that removing the temporary pacing wire includes applying a heat energy thereto.

[0024] In an embodiment, the heat energy is applied via a heating element extending about the low melting point phase change material.

[0025] In an embodiment, an insulating tubing extends about the heating wire to protect a surrounding tissue.

[0026] In an embodiment, the releasable electrical connection is spring-loaded so that a release thereof further facilitates the detachment of the proximal portion from the distal portion.

[0027] In an embodiment, removal of the proximal portion is initiated upon confirmation of release of the releasable electrical connection via a temperature sensor.

[0028] In an embodiment, applying an energy to the releasable electrical connection to release the electrical connection includes controlling a level of the energy based on a feedback signal indicative of a temperature of the releasable connection.

[0029] The present disclosure is also directed to a medical device. The medical device comprises a distal portion configured to be inserted into a patient body and a proximal portion configured to extend to an exterior of the patient body. The medical device also comprises a releasable connection coupling the distal and proximal portions and configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body with negligible force.Attorney Docket No. 50124 / 10302 (EST01-02PCT)BRIEF DESCRIPTION OF THE FIGURES

[0030] Fig. 1 shows a schematic diagram of a system according to an exemplary embodiment of the present disclosure, before detachment of a temporary pacing wire thereof.

[0031] Fig. 2 shows a schematic diagram of the system according to Fig. 1, after detachment of the temporary pacing wire.

[0032] Fig. 3 shows a side view of a proximal portion of the temporary pacing wire according to the exemplary system of Fig. 1.

[0033] Fig. 4 shows an enlarged view of a releasable electrical connection of the temporary pacing wire according to the system of Fig. 1, prior to release.

[0034] Fig. 5 shows an enlarged view of the releasable electrical connection of the temporary pacing wire according to the system of Fig. 1, after release.

[0035] Fig. 6 shows a schematic diagram of a system according to a further exemplary embodiment of the present disclosure.

[0036] Fig. 7 shows a schematic diagram of a system according to yet another exemplary embodiment of the present disclosure.

[0037] Fig. 8 shows a flow chart of a method according to an exemplary embodiment of the present disclosure.DETAILED DESCRIPTION

[0038] The present disclosure may be understood with reference to the following description and the appended drawings. The present disclosure relates to a system and method for cardiac pacing and, in particular, relates to a system and method for a detachable temporary pacing wire.Attorney Docket No. 50124 / 10302 (EST01-02PCT)Exemplary embodiments of the present disclosure describe a system and method in which a temporary pacing wire includes a distal portion configured to be implanted in and sutured to a cardiac tissue for cardiac pacing and a proximal portion electrically connected to the distal portion via a releasable connection and configured to extend through the skin to be coupled to an external pacemaker.

[0039] In an exemplary embodiment, the releasable connection includes a low melting temperature phase change material encasing the electrical connection and configured so that, when it is desired to remove the temporary pacing wire from the body, heat having a temperature exceeding a threshold value is applied to the low temperature phase change material to melt the material. The melting of the material releases the connection between the distal and proximal portions of the wire so that the proximal portion may be mechanically separated from the distal portion via a gentle proximal pull thereof, leaving just the distal portion connected to the heart.

[0040] The distal portion forms a small portion of the temporary pacing wire which, as will be understood by those of skill in the art, may safely remain in the patient body. It will be understood by those of skill in the art that the terms “proximal” and “distal,” as used herein, refer to a direction toward and away from a user (e.g., surgeon, physician) of the system. It will also be understood by those of skill in the art that although the exemplary embodiments specifically show and describe a temporary pacing wire including the releasable connection, the releasable connection may be similarly incorporated into other medical devices in which a tensionless and / or near-tensionless detachment mechanism, as described herein, may be desired.

[0041] As shown in Figs. 1-5, a system 100 according to an exemplary embodiment of the present disclosure comprises a temporary pacing wire 102 configured to be coupled to an electronic pacing device (e.g., an external pacemaker 104) via, for example, a cable (not shown). The temporary pacing wire 102 may be placed during, for example, cardiac surgery to provide temporary, post-operative cardiac pacing and / or monitoring. According to an exemplary embodiment, the temporary pacing wire 102 includes a distal portion 106 and a proximal portion 108 connected to one another via a releasable electrical connection 110, as shown in Figs. 1 and 4.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0042] A distal end 112 of the distal portion 106 is configured to be implanted and / or embedded in cardiac tissue 10 (e.g., epicardium) so that a portion of the distal portion 106 extending out of the cardiac tissue 10 may be sutured to an exterior surface 12 of the cardiac tissue 10 via a suture 14. The proximal portion 108 is configured to be pierced through the skin to an exterior of a patient body to be coupled to the external pacemaker 104. In an exemplary embodiment, the releasable electrical connection 110 includes a low melting temperature phase change material 126 configured so that, when subject to heat at a temperature exceeding a threshold value, the low-temperature phase change material melts.

[0043] Melting of the low temperature phase change material releases the releasable electrical connection 110 so that the proximal portion 108 may be mechanically separated from the distal portion 106, as shown in Figs. 2 and 5, leaving just the distal portion 106 connected to the heart upon removal of the temporary pacing wire 102. The low melting temperature phase change material 126 facilitates detachment of the proximal portion 108 from distal portion 106 via negligible force such that the user may securely suture the distal portion 106 to the cardiac tissue 10 without having to worry about traumatic damage thereto (e.g., tears or bleeding) during a detachment of the temporary pacing wire 102. It will be understood by those of skill in the art that a more secure attachment will result in better contact and thus, more reliable pacing.

[0044] The distal portion 106 of the temporary pacing wire 102 extends longitudinally from the distal end 112 to a proximal end 116. A segment of the distal portion 106 may be coated and / or otherwise covered via a non-conductive material 118 so that the distal end 112 and the proximal end 116 remain exposed. The covered segment of the distal portion 106 is insulated so that the exposed distal end 112 acts as an electrode configured to provide pacing to the heart. The distal end 112 may have any of a variety of shapes and configurations facilitating implantation thereof within the cardiac tissue 10. In an exemplary embodiment, the distal end 112 may extend along a curve and / or angled relative to a remaining length thereof to, for example, anchor the distal end 112 within the cardiac tissue 10. In an exemplary embodiment, the distal end 112 may be shaped and configured to have a larger area of contact with the cardiac tissue to provide more reliable capture and pacing. For example, the distal end 112 may be discAttorney Docket No. 50124 / 10302 (EST01-02PCT) and / or box shaped. The exposed proximal end 116 is, as will be described in greater detail below, configured to contact a distal end 120 of the proximal portion 108 to form the releasable electrical connection 110 therebetween.

[0045] The proximal portion 108 of the temporary pacing wire 102 extends longitudinally from the distal end 120 to a proximal end. In an exemplary embodiment, a segment of the proximal portion 108 is coated with a non-conductive material 124 such that the distal end 120 is exposed. As described above, the distal end 120 is exposed so that the distal end 120 may be placed in contact with the exposed proximal end 116 of the distal portion 106 to form the releasable electrical connection 110. The proximal end 122 of the proximal portion 108 may, in an exemplary embodiment, include a needle 138 configured to pierce through the skin so that the proximal end 122 may extend to an exterior of the patient body to be connected to the external pacemaker 104. In some embodiments, the needle 138 may be configured to be broken and / or snapped off to facilitate a coupling of the proximal end 122 with, for example, a cable which connects the temporary pacing wire 102 with the external pacemaker 104.

[0046] The non-conductive material 118, 124 extending along portions of the distal portion 106 and the proximal portion 108, respectively, may include any of a variety of materials configured to insulate the desired segments of the distal and proximal portions 106, 108. In one example, the non-conductive material 118, 124 may include a polytetrafluoroethylene (PTFE).

[0047] As described above, in an exemplary embodiment, the releasable electrical connection 110 includes the low melting temperature phase change material 126 encasing the proximal end 116 of the distal portion 106 and the distal end 120 of the proximal portion 108, in a first phase (e.g., solid), so that the proximal end 116 and the distal end 120 remain in direct contact with one another, as shown in Figs. 1 and 4. In one example, the low melting temperature phase change material 126 may encase the proximal end 116 and the distal end 120 in an overlapping configuration. When subject to an energy exceeding a threshold value, however, the low melting temperature phase change material transitions to a second phase (e.g., liquid), to release the releasable electrical connection 110.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0048] The low melting temperature phase change material 126 may include any of a variety of materials configured to change phase and / or state when subject to a heat exceeding a threshold temperature to facilitate a detachment of the proximal portion 108 from the distal portion 106. In an exemplary embodiment, the low melting temperature phase change material 126 may include, for example, a wax or other similar material such as thermoplastics, glues, or polymers which, when subject to the threshold level of heat, melts to release the releasable electrical connection 110 between the proximal end 116 of the distal portion 106 and the distal end 120 of the proximal portion 108. In another embodiment, the material may include low melting temperature metal such as, for example, Gallium, or a shape memory alloy such as, for example, Nitinol, which also goes through a phase change and changes size and / or shape when exposed to heating and a temperature change.

[0049] According to an exemplary embodiment, heat may be applied to the low melting temperature phase change material 126 via an electrical heating element 128 extending about the releasable electrical connection 110 and connected to an external electrical power source 130 configured to provide heat energy to the heating element 128. In an exemplary embodiment, the heating element 128 may be configured as a resistive heating wire that is coiled about the low melting temperature phase change material 126. In this embodiment, the heating wire may be connected to the electrical power source 130 via an insulated length of the heating element extending between the releasable electrical connection 110 and the electrical power source 130. References to the heating element 128, however, will describe the electrically conductive portion configured to deliver / apply heat to the low melting temperature phase change material 126.

[0050] It will be understood by those of skill in the art, however, that the heating element 128 may have any of a variety of configurations relative to the low melting temperature phase change material 126 and the releasable electrical connection 110 so long as the heating element 128 is configured to apply heat to the low melting temperature phase change material 126 in a manner that would facilitate release of the releasable electrical connection 110 and / or detachment of the temporary pacing wire 102. In another embodiment, for example, the heating element 128 may include resistive chips (integrated circuits) or lithographically patterned and / orAttorney Docket No. 50124 / 10302 (EST01-02PCT) structured resistive films configured to deliver and / or apply heat to the low melting temperature phase change material 126.

[0051] In an exemplary embodiment, the releasable electrical connection 110 and, in particular, the heating element 128, includes an insulated tubing 132 extending thereabout. The insulated tubing 132 extends longitudinally from a distal end 134 to a proximal end 136 and is configured to extend about and along the heating element 128 and / or the releasable electrical connection 110. The insulated tubing 132 is configured to protect a surrounding tissue from the heat of the heating element 128 during a removal process of the temporary pacing wire 102 - i.e., during a release of the releasable electrical connection 110. Upon release of the releasable electrical connection 110, the proximal portion 108 may be detached and / or separated from the distal portion 106 so that the proximal portion 108 along with the heating element 128 may be removed from the patient body while the distal portion 106 remains connected to the cardiac tissue 10, as shown in Fig. 2.

[0052] In one exemplary embodiment, upon release of the releasable electrical connection 110, the insulated tubing 132 may remain connected to the distal portion 106, extending over the exposed proximal end 116 thereof. In another exemplary embodiment, the insulated tubing 132 may be removable from the patient body along with the proximal portion 108 and the heating element 128. Thus, to facilitate release of the distal portion 106 such that the proximal portion 108 is detached therefrom and removable from the patient body, the insulated tubing 132 may be connected to one of the distal and proximal portions 106, 108.

[0053] In one exemplary embodiment, the distal end 134 of the insulated tubing 132 may be connected to a portion of the distal portion 106 such as, for example, the non-conductive material 118 thereof. In another exemplary embodiment, the proximal end 136 of the insulated tubing 132 may be attached to a portion of the proximal portion 108 proximal of the exposed distal end 120 thereof- e.g., the non-conductive material 124. A diameter of the insulated tubing 132 is such that it is permitted to distend the skin and pass through the same access point through which the proximal portion 108 of the temporary pacing wire 102 extends.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0054] In another exemplary embodiment, as shown in Fig. 6 a system 200 may be substantially similar to the system 100, as described above, comprising a temporary pacing wire 202 including a distal portion 206 and a proximal portion 208 connected to one another via a releasable electrical connection 210. The temporary pacing wire 202 and the releasable electrical connection 210 may be substantially similar to the temporary pacing wire 102 and the releasable electrical connection 110 described above with respect to the system 100. The releasable electrical connection 210, however, may further include a spring -loaded feature 240 configured so that, when a low melting temperature phase change material 226 transitions from a first phase to a second phase (e.g., from a solid to a liquid) via a heat applied by a heating element 228, the tension in the spring-loaded feature 240 releases to sever the connection between the distal and proximal portions 206, 208.

[0055] In yet another embodiment, the releasable electrical connection 210 may further include a temperature sensor 242 configured to indicate when a temperature at the releasable electrical connection 210 (e.g., a heat applied to the low melting temperature phase change material 226 via the heating element 228) exceeds the threshold value required to change the low melting temperature phase change material 226 from the first phase to the second phase. The temperature sensor 242 may, for example, be embedded within the low melting temperature phase change material 226. The temperature sensor 242 may have any of a variety of configurations including, for example, a thermistor, a thermocouple, a digital IC sensor, etc.

[0056] In an exemplary embodiment, the temperature sensor 242 is readable to the user via analog and / or digital electronics so that the user may determine when the low melting temperature phase change material 226 has changed phases (e.g., melted) and thus released the releasable electrical connection 210 such that it is safe to remove the proximal portion 208 from the patient body. In another embodiment, the temperature sensor 242 may be connected to an audio or visual indicator such as, for example, a light emitting diode or speaker which will alert a user when it is safe to draw the proximal portion proximally 208 out of the patient body - e.g., when the low temperature phase change material 226 has melted and thus presents little to no resistance to draw out of the body.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0057] According to a further exemplary embodiment, as shown in Fig. 7, a system 300 may be substantially similar to the system 200 described above, comprising a distal portion 306 and a proximal portion 308 of a temporary pacing wire 302 connected to one another via a releasable electrical connection 310. Similarly to the releasable electrical connection 210 of the system 200, the releasable electrical connection 310 also includes a temperature sensor 342 configured to detect a temperature at the releasable electrical connection 310.

[0058] In an exemplary embodiment, the temperature sensor 342 may be embedded within a low melting temperature phase change material 326 of the releasable electrical connection 310 which encases a portion of the distal portion 306 and the proximal portion 308 in electric contact with one another. The temperature sensor 342 is configured to detect a temperature of the low melting temperature phase change material, which is transmitted to, for example, an external temperature reader 344. According to an exemplary embodiment, the external temperature reader 344 provides the detected temperature as a feedback signal 346 to an external electrical power source 330 of the heating element 328 so that a controller of the power source 330 may correspondingly control a level of heat applied to the low melting temperature phase change material 326 via, for example, a current supplied through the heating element 328. For example, the controller of the power source 330 may be configured to continue to increase a heat delivered via the heating element 328 until the measured temperature (via the temperature sensor 342) reaches the predetermined threshold value. Thus, a release of the releasable electrical connection 310 may be optimized while also preventing overheating.

[0059] Although the system 100 (and systems 200, 300) is described as including a single temporary pacing wire 102, it will be understood by those of skill in the art that the system 100 may include a plurality of temporary pacing wires 102. In an exemplary embodiment, the system 100 may include two temporary pacing wires 102, a first one of the temporary pacing wires 102 configured for atrial placement and a second one of the temporary pacing wires 102 for ventricular placement. It will also be understood by those of skill in the art that the temporary pacing wire 102 may be configured as a bipolar pacing wire which includes an integrated ground or a unipolar pacing wire which requires a separate ground wire.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0060] Fig. 8 shows an exemplary method 400 for cardiac monitoring and / or pacing utilizing the system 100 (or systems 200, 300) in which the temporary pacing wire 102 may be placed during, for example, a cardiac surgery, so that the temporary pacing wire 102 may provide postoperative monitoring and pacing of the heart while also facilitating a subsequent, safe removal thereof. In a step 402, the distal end 112 of the distal portion 106 of the temporary pacing wire 102 is implanted or otherwise inserted / embedded into a target area of a cardiac tissue 10 (e.g., epicardium). As described above, the distal end 112 is exposed - i.e., not covered via the non- conductive material 118 - so that the distal end 112 acts as a pacing electrode.

[0061] Once the distal end 112 has been implanted into the cardiac tissue 10, as desired, a remining length of the distal portion 106 extending from the distal end 112 to an exterior of the heart may be sutured to an exterior surface 12 of the cardiac tissue. The distal portion 106 may be sutured, e.g., via the suture 14, to the skin along an area proximal of the distal end 112 (e.g., electrode) and distal of the insulated tubing 132 and the releasable electrical connection 110. The distal portion 106 may be sutured to the cardiac tissue 10, distally of the releasable electrical connection 110.

[0062] Once the distal portion 106 has been placed as desired, in a step 404, the proximal portion 108 is pierced through a skin along a chest area of the patient from an interior of the patient body to an exterior thereof, the proximal portion 108 extending therethrough so that the proximal end 122 thereof may be connected to the external pacemaker 104 via, for example, a cable. According to an exemplary embodiment, as described above, the proximal end 122 may include the needle 138 for piercing the skin. Upon piercing of the skin, the needle 138 may be broken and / or snapped off so that the proximal end 122 may be connected to the external pacemaker 104 via, for example, a cable, in a step 406. The surgical site may be sutured closed such that the distal portion 106 is placed within the body and just the proximal portion 108 is accessible to a user (e.g., surgeon or other medical practitioner).

[0063] In a step 408, the temporary pacing wire 102 is used to monitor and / or provide pacing to the patient. It will be understood by those of skill in the art that although not described in detail, the external pacemaker 104 is configured to be set, as desired, to include desiredAttorney Docket No. 50124 / 10302 (EST01-02PCT) parameters such as, for example, a mode (e.g., sensing or pacing), a desired rate of pacing, and an output indicative of a desired level of energy to be delivered via the temporary pacing wire. The temporary pacing wire 102 may remain in the body until it is determined until it is shown that the patient has a rhythmically stable heart rate. In an exemplary embodiment, the temporary pacing wire 102 may remain within the patient body from between 2 and 14 days. In another exemplary embodiment, the temporary pacing wire 102 may remain within the patient body between 7 and 10 days.

[0064] According to an exemplary embodiment, when it is has been determined that the temporary pacing wire 102 should be removed, the user may initiate a removal in a step 410. To remove the temporary pacing wire 102 from the patient body, the heating element 128 is energized via the electrical power source 130 to deliver heat to the low melting temperature phase change material 126, which encases the proximal end 116 of the distal portion 106 and the distal end 120 of the proximal portion 108 in contact with one another to form the releasable electrical connection 110. Once the heat delivered to the low melting temperature phase change material 126 exceeds the threshold temperature, the low melting temperature phase change material 126 melts to release the releasable electrical connection 110. In particular, once the low melting temperature phase change material 126 melts, a gentle drawing of the proximal portion 108 of the temporary pacing wire 102 in a proximal direction via the user detaches the proximal portion 108 from the distal portion 106 so that the distal portion 106 may be entirely removed from the patient body.

[0065] As shown in Fig. 2, the proximal portion 108, including the heating element 128 and the insulated tubing 132, are removed from the patient body leaving just the distal portion 106, which amounts to a very small portion of a length of the overall temporary pacing wire 102, connected to the heart via the sutures. It will be understood by those of skill in the art that the distal portion 106 remaining in the body may extend along a variety of lengths depending on factors such as, for example, a length of the distal end (e.g., anchor) and / or a type of anchoring used. In one example, the remaining length of the distal portion 106 may extend between 5cm and 10cm.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0066] It will be understood by those of skill in the art that although the method 400 has been described above with respect to the system 100, the method 400 may similarly utilize the systems 200 and / or 300. In the step 410, however, release of the releasable electrical connection 210 may be further facilitated via the spring-loaded feature 240. In particular, upon melting of the low melting temperature phase change material 226 the spring-loaded feature 240 facilitates separation of the distal and proximal portions 206, 208. In addition, or alternatively, the user may begin to remove the proximal portion 208 from the patient body once, for example, the temperature sensor 242 indicates that the releasable electrical connection 210 has released (e.g., the low melting temperature phase change material has melted) so that the proximal portion 208 is detachable from the distal portion 206.

[0067] When the method 400 utilizes the system 300, a release of the releasable electrical connection 310 (in the step 410) may be optimized by controlling a level of heat applied to the low melting temperature phase change material 326 via the heating element 328 based on a detected temperature at the releasable electrical connection 310. As described above, a signal from the temperature sensor 342 is transmitted to the power source 330 of the heating element 328 as a feedback signal 346 so that the power source may control the heat applied to the releasable electrical connection 310, optimizing release of the releasable electrical connection 310 and preventing overheating of the system 300. As discussed above, once the temperature at the releasable electrical connection 310 reaches the predetermined threshold value to melt the low melting temperature phase change material, the proximal portion 308 is released from the distal portion 306 so that the proximal portion 308 may be removed from the body.

[0068] It will be understood by those of skill in the art that since the temporary pacing wire 102 (or the temporary pacing wire 202, or the temporary pacing wire 302) is detachable, as described above, to allow for safe extraction thereof, the temporary pacing wire 102 may be more securely fixed to the cardiac tissue 10 as the user need not worry about forces required during removal. The releasable electrical connection 110 is configured to provide a near-zero force or tension on the surface of the heart.Attorney Docket No. 50124 / 10302 (EST01-02PCT)

[0069] Although the exemplary embodiments show and describe a temporary pacing wire, it will be understood by those of skill in the art that the exemplary releasable connection described herein may also be incorporated into other medical devices (e.g., therapeutic, diagnostic, or monitoring) in which a near-zero force or tension is desired for detachment. The medical device may include, for example, a distal portion inserted into a patient body and connected to a proximal portion via the releasable connection, which is configured to release when subject to an energy exceeding a predetermined threshold value. As described above, the releasable connection may include a low melting temperature phase change material configured to transition from a first phase (e.g., solid) to a second phase (e.g., liquid) when subject to a heat energy exceeding the threshold value to release the connection between the distal and proximal portions.

[0070] In particular, in the first phase, the low melting temperature phase change material connects the distal and proximal portions. When, however, a treatment, diagnosis and / or monitoring has been completed via the medical device and it is desired to remove the proximal portion from the body, a heating element may apply a heat to the low melting temperature phase change material so that the low melting temperature phase change material melts, releasing the connection between the distal and proximal portions. Thus, the proximal portion may be detached from the distal portion and removed from the patient body via negligible force, preventing any traumatic damage to the body during the detachment.

[0071] Medical devices incorporating the releasable connection may include, for example, therapeutic devices such as drug delivery and / or feeding devices (e.g., patches, fluid tubes), diagnostic devices (e.g., electrical impedance measuring devices), and interventional devices (e.g., laser ablation, RF coil ablation). It will be understood by those of skill in the art that the releasable connection of the present disclosure may be included in any of a variety of medical devices in which tensionless detachment is desired.

[0072] The disclosure described and claimed herein is not to be limited in scope by the specific embodiments herein disclosed since these embodiments are intended as illustrations of several aspects of this disclosure. Any equivalent embodiments are intended to be within theAttorney Docket No. 50124 / 10302 (EST01-02PCT) scope of this disclosure. Indeed, various modifications of the disclosure in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

Claims

Attorney Docket No. 50124 / 10302 (EST01-02PCT)CLAIMSWhat is claimed is:

1. A temporary cardiac pacing system, comprising: a temporary cardiac pacing wire including a distal portion and a proximal portion connected to one another via a releasable electrical connection, an electrode of the distal portion configured to be implanted in a cardiac tissue, the proximal portion configured to extend through a skin to an exterior of a patient body to be coupled to an external pacemaker device, the releasable electrical connection configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body with negligible force.

2. The system of claim 1, wherein the distal portion extends longitudinally from a proximal end to a distal end, a segment of the distal portion covered via a non-conductive material such that the distal and proximal ends of the distal portion remain exposed, the exposed distal end of the distal portion defining the electrode.

3. The system of claim 2, wherein the proximal portion extends longitudinally from a proximal end to a distal end, a segment of the proximal portion covered via the non- conductive material such that distal end of the proximal portion remains exposed.

4. The system of claim 3, wherein the proximal end of the proximal portion includes a needle configured to pierce through the skin.

5. The system of claim 3, wherein the releasable electrical connection is formed via contact between the exposed distal end of the proximal portion and the exposed proximal end of the distal portion.Attorney Docket No. 50124 / 10302 (EST01-02PCT)6. The system of claim 5, wherein the releasable electrical connection further includes a low melting point phase change material encasing the exposed distal end of the proximal portion and the exposed proximal end of the distal portion in contact with one another, the low melting point phase change material configured to melt when subject to a heat energy exceeding the predetermined threshold value.

7. The system of claim 6, further comprising: a heating element configured to extend about the low melting point phase change material to deliver a heat energy configured to release the releasable electrical connection.

8. The system of claim 6, wherein the low melting point phase change material includes one of a wax, thermoplastic polymer, and a metal.

9. The system of claim 7, further comprising: an insulating tubing extending about the heating element and the releasable electrical connection to protect a surrounding tissue from the heat energy.

10. The system of claim 7, further comprising: a temperature sensor configured to detect when the low melting temperature phase change material has melted to release the releasable electrical connection.

11. The system of claim 10, wherein a signal from the temperature sensor is transmitted as a feedback signal to a controller configured to control a current supplied to the heating element based on the feedback signal to optimize a release of the releasable electrical connection and reduce risk of overheating.

12. The system of claim 1, wherein the releasable electrical connection is spring-loaded to facilitate detachment of the proximal portion from the distal portion.

13. A temporary cardiac pacing wire, comprising:Attorney Docket No. 50124 / 10302 (EST01-02PCT) a distal portion extending longitudinally from a proximal end to a distal end including an electrode configured to be implanted into a cardiac tissue to provide cardiac pacing thereto; a proximal portion extending longitudinally from a proximal end to a distal end, the proximal portion configured to be inserted through a skin to an exterior of a patient body to be coupled to an external pacemaker device; and a releasable connection connecting the proximal end of the distal portion and the distal end of the proximal portion in electrical contact with one another, the releasable connection configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body via a negligible force.

14. The temporary cardiac pacing wire of claim 13, wherein the releasable connection includes a low melting point phase change material which holds the distal and proximal portions in electrical contact with one another when in a first phase and releases the releasable connection between the distal and proximal portions in a second phase, the low melting point phase change material transitioning from the first phase to the second phase when subject to a heat energy exceeding the predetermined threshold value.

15. The temporary cardiac pacing wire of claim 13, further comprising: a heating element extending about the releasable connection to deliver a heat energy configured to release the releasable connection.

16. The temporary cardiac pacing wire of claim 15, further comprising: an insulating tube extending about the heating element to protect a surrounding tissue from the heat energy.

17. The temporary cardiac pacing wire of claim 13, wherein a segment of the distal portion is covered via a non-conductive material such that the distal and proximal ends of the distal portion remain exposed, the exposed distal end of the distal portion defining the electrode.Attorney Docket No. 50124 / 10302 (EST01-02PCT)18. The temporary cardiac pacing wire of claim 13, wherein a segment of the proximal portion covered via a non-conductive material such that distal end of the proximal portion remains exposed.

19. A method for providing temporary cardiac pacing, comprising: implanting an electrode along a distal portion of a temporary pacing wire in a cardiac tissue; suturing a portion of the distal portion proximal of the electrode to an exterior surface of the cardiac tissue to secure the electrode therein; passing a proximal portion of the temporary cardiac pacing wire through a skin to an exterior of a body of a patient to couple a proximal end of the proximal portion to an external pacemaker device, the proximal portion connected to the distal portion via a releasable electrical connection; providing one of a monitoring and a pacing of a heart of the patient via the temporary cardiac pacing wire for a desired period of time; applying an energy to the releasable electrical connection to release the releasable electrical connection; and detaching the proximal portion from the distal portion with negligible force so that the proximal portion is removable from the body while the distal portion remains securely attached to the cardiac tissue.

20. The method of claim 19, wherein the releasable electrical connection includes a low melting point phase change material which holds a proximal end of the distal portion and a distal end of the proximal portion in electrical contact with one another so that removing the temporary cardiac pacing wire includes applying a heat energy thereto.

21. The method of claim 20, wherein the heat energy is applied via a heating element extending about the low melting point phase change material.Attorney Docket No. 50124 / 10302 (EST01-02PCT)22. The method of claim 21, wherein an insulating tubing extends about the heating element to protect a surrounding tissue.

23. The method of claim 19, wherein the releasable electrical connection is spring-loaded so that a release thereof further facilitates the detachment of the proximal portion from the distal portion.

24. The method of claim 19, wherein removal of the proximal portion is initiated upon confirmation of release of the releasable electrical connection via a temperature sensor.

25. The method of claim 19, wherein applying an energy to the releasable electrical connection to release the releasable electrical connection includes controlling a level of the energy based on a feedback signal indicative of a temperature of the releasable electrical connection.

26. A medical device, comprising: a distal portion configured to be inserted into a patient body and a proximal portion configured to extend to an exterior of the patient body; and a releasable connection coupling the distal and proximal portions and configured to release when subject to an energy exceeding a predetermined threshold value such that the proximal portion is detachable from the distal portion and removable from the patient body with negligible force.

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