WO2008027187A2

WO2008027187A2 - Adaptor for temporary pacemaker

Info

Publication number: WO2008027187A2
Application number: PCT/US2007/017978
Authority: WO
Inventors: Michael A. Fifer; David T. Abate
Original assignee: The General Hospital Corporation
Priority date: 2006-08-29
Filing date: 2007-08-14
Publication date: 2008-03-06
Also published as: WO2008027187A3

Abstract

Devices and methods are provided for securing an implantable medical element. In one embodiment, a locking device is provided having a proximal locking component, a protective sleeve, and a second locking member. The proximal locking component can have a hub that is adapted to be attached to a portion of an introducer assembly for the implantable medical element. The proximal locking component can also include a first locking member that is selectively engageable to a first portion of the medical element that extends from a patient's body. The protective sleeve can extend distal Iy from the locking member of the proximal locking component, and the second locking member can be disposed at a distal end of the protective sleeve. The second locking member can be selectively engageable to a second portion of the medical element.

Description

ADAPTOR FOR TEMPORARY PACEMAKER

FIELD OF THE INVENTION The present invention relates to devices and methods for securing an implantable medical element.

BACKGROUND OF THE INVENTION

Temporary cardiac pacing uses an electrical device such as a temporary pacing wire or electrical lead to regulate a patient's heartbeat. Temporary pacing leads are generally only needed for a few days because they are either replaced by a more permanent pacemaker cell or pacing is no longer needed because the patient's heartbeat has returned to normal.

Temporary cardiac pacing is often used when a heart attack damages the pathways that carry electrical signals in the heart. Damage from a heart attack causes the heart rate to slow, and temporary pacing is used to regulate the heart rate until the damaged pathways heal. Temporary pacing is also employed when something causes the heart to "short circuit" resulting in a very rapid and irregular heartbeat. Here, temporary pacing is used to control the heartbeat until medications take effect. Other applications include use of a temporary pacing wire until a permanent pacemaker can be installed when the heart is damaged by disease or aging and stabilization of the heart rhythm following open heart surgery.

In general, temporary pacing wires have an electrode disposed at one end and a small pulse generator box containing batteries at the other end. The electrode end is inserted into the lower right chamber (i.e., the right ventricle) of the heart, and the generator box remains outside the patient's body. Temporary pacing wires are secured to the patient's body by either sterile tape or sutures with the appropriate sterile dressing. Despite efforts to secure the pacing devices, the wires often migrate from their intended target due to time, anatomy, dressing changes, patient movement, and other causes. Electrode migration can cause the loss of pacing capture, perforation of the heart, and infection. Moreover, after a temporary pacing electrode is placed, the remaining portion of the electrode that is disposed outside the patient cannot be advanced, if necessary, due to lack of sterility. Accordingly, a need exists for methods and devices for securing a temporary pacing electrode.

SUMMARY OF THE INVENTION

The present invention generally provides devices and methods for securing an implantable medical element. In one embodiment, a locking device is provided having a proximal locking component, a protective sleeve, and a second locking member. The proximal locking component can have a hub that is adapted to be attached to a portion of an introducer assembly for the implantable medical element. The proximal locking component can also include a first locking member that is selectively engageable to a first portion of the medical element that extends from a patient's body. The protective sleeve can extend distally from the locking member of the proximal locking component and can optionally be transparent to facilitate viewing of the medical element extending therethrough. The second locking member can be disposed at a distal end of the protective sleeve and can be selectively engageable to a second portion of the medical element.

The first and second locking members can have a variety of configurations. For example, the locking member can include a male component that is adapted to be received by a female component. In one exemplary embodiment, the male component can be threadably received by the female component. A portion of the male component can be compressible, and the female component can be configured to compress the male component such that compressing the male component is effective to engage the medical element extending therethrough. In one embodiment, the compressible portion of the male component can be an elastic diaphragm.

In another aspect of the invention, a kit for securing an implantable medical element is provided. The kit can include a locking device and an implantable medical element. Various configurations are available for the locking device, but in one exemplary embodiment the locking device includes a proximal locking component, a protective sleeve extending distally from the proximal locking component, and a distal locking component disposed at a distal end of the protective sleeve. The implantable medical element can also take a variety of forms. For example, in one exemplary embodiment, the implantable medical element can be an electrical medical element such as a temporary pacing electrode.

A method of securing an implantable medical element is also provided and includes inserting an implantable electrical medical lead into a locking device that is positioned adjacent an entry port in a patient, advancing the surgical lead through the locking device and into the patient's body, positioning the implantable electrical medical lead at a desired location in the patient's heart, and locking the locking device to thereby secure the surgical lead relative to an introducer for the lead.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of one embodiment of a locking device for an implantable medical element;

FIG. 2 is a cross-sectional view of one embodiment of the proximal locking component of the locking device shown in FIG. 1; and

FIG. 3 is a cross-sectional view of another embodiment of the proximal locking component of the locking device shown in FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. - A -

The present invention generally provides devices and methods for securing an implantable medical element. The methods and devices utilize a locking device that can be formed on, attached to, or removably matable to a portion of an introducer assembly for the implantable medical element. The locking device can include a proximal locking component that has a first locking member that is selectively engageable to a first portion of the implantable medical element extending from a patient's body. The locking device can also include a protective sleeve that extends distally from the locking member of the proximal locking component and a second locking member that is disposed at a distal end of the protective sleeve and is selectively engageable to a second portion of the implantable medical element. The locking device can be used to secure a variety of implantable medical elements. For example, in one embodiment the locking device can be used to secure an electrical medical lead such as a temporary pacing electrode. In other embodiments, the locking device can be used to secure, for example, a pulmonary artery catheter, a pulmonary arterial catheter, or a percutaneous ventricular assist device. A person skilled in the art will appreciate that the locking device can be used with a variety of cardiac implants as well as implants used in other surgical procedures.

FIG. 1 illustrates one exemplary embodiment of a locking device 100 for securing an implantable medical element and having a proximal locking component 110, a protective sleeve 112, and a second locking member 114. In the illustrated embodiment, the proximal locking component 110 has a hub 116 that is adapted to be attached to a portion of an introducer assembly (not shown) for the implantable medical element (not shown) and a first locking member 118 that is selectively engageable to a first portion of the implantable medical element. The protective sleeve 112 can extend distally from the first locking member 118, and a second locking member 114 can be disposed at a distal end of the protective sleeve 112. Similar to the first locking member 118, the second locking member 114 can also be selectively engageable to a portion of the implantable medical element. In use, the implantable medical element can be advanced through the locking device 100 and into a patient's body. Once the medical element is appropriately positioned in the body, the first and second locking members 118, 114 can be locked to secure placement of the element. The portion of the implantable medical element that is disposed within the protective sleeve 112 remains sterile thereby enabling further advancement of the element if necessary. The device 100 can thus be used to secure and stabilize an implantable medical element as well as allow a physician to withdraw and advance the element while minimizing the risk of contamination.

The proximal locking component 110 can have various shapes and sizes, but in one exemplary embodiment, as shown in FIG. I₃ the proximal locking component 110 is in the form of a hub 116 that is adapted to be attached to a portion of an introducer assembly for the implantable medical element and a first locking member 118 that is selectively engageable to a first portion of the medical element extending from the patient's body. The hub 116 can have a variety of configurations. As shown, the hub 116 is cylindrical in shape and sized such that it can be removably mated to a portion of an introducer assembly. Various techniques can be used to secure a proximal portion of the hub 116 to the introducer assembly. For example, the hub can be formed from an elastic or malleable material thereby enabling the user to place the hub 116 over a portion of the introducer assembly in an overlapping fashion to achieve a slide-fit. Other techniques for securing the hub 116 to the introducer assembly can include a snap-fit, interference fit, or threaded engagement. The hub 116 can also include a notched portion 117 to ensure proper mating of the locking device 100 to an introducer assembly having a side-port tube (not shown). Although the notched portion 117 is shown at the proximal end 116a of the hub 116, a person skilled in the art will appreciate that the notched portion 117 can be formed and/or extend to any portion of the hub 116.

As indicated above, the proximal locking component 110 can also include a first locking member 118 that is selectively engageable to a first portion of an implantable medical element extending from a patient's body. As shown in FIG. 1 , the first locking member 118 is disposed at a distal end 116b of the hub 116. A variety of mechanisms can be used to selectively engage a portion of the implantable medical element. For example, in one exemplary embodiment, the first locking member 118 can include a male component that is adapted to be received by a female locking component. In this embodiment, a portion of the male component can be compressible, and the female component can be configured to compress the male component as the male component is inserted into the female component. The male component can have a longitudinal lumen or bore extending therethrough to facilitate passage of the medical element. The female component can be sized and shaped to apply a force to the male component that is effective to compress a portion of the male component such that it engages the medical element extending through the lumen of the male component. The male component can engage the medical element such that migration of the element is prevented. The engagement can be tight enough to ensure that the medical element cannot migrate proximally or distally but not too tight so as to cause damage, stress, and/or distortion to the medical element.

A variety of configurations are available for the male and female components of the first locking member 118. For example, in one exemplary embodiment shown in

FIG. 2, the male component 200 includes a generally cylindrical proximal portion 200a and a tapered distal portion 200b. The tapered distal portion 200b can have threads 200c formed thereon for mating with complementary threads 210a formed on the female component 210. A longitudinal lumen or bore 220 can extend through the male component 200 to facilitate passage of the medical element. In this embodiment, the entire male component 200 or a portion thereof (e.g., the tapered distal portion 200b) can be formed from an elastic or compressible material. As shown in FIG. 2, the female component 210 is shaped similarly to the tapered distal portion 200b of the male component 200 and has a cylindrical bore 212 having tapered and non-tapered sections 212a, 212b extending therethrough. The tapered section 212a of the bore 212 can have threads 210a formed therein and can be sized to compress the distal portion 200b of the male component 200 as the male component 200 is threadably received by the female component 210. Referring back to FIG. 1, the proximal locking component 110 can also include a guide tube 120 that extends distally from the first locking member 118. The guide tube 120 acts to guide the trajectory of the medical element through the locking device 100 and ease insertion into the locking member 118. The guide tube 120 can optionally include markings to allow for precise adjustment of the medical element. The device 100 can also include a safety mechanism to ensure that the medical element is not damaged by the locking member 118. Various configurations and techniques can be used for the safety mechanism, but in one embodiment, interruptions in the smooth surfaces of the threads on the male and female locking components 200, 210 can be employed to detent the tightening of the locking member 118 and provide tactile and/or audible feedback to the user. In use, the male component 200 can be partially threaded into the female component 210 such that the two components are engaged but the male component 200 is not yet compressed. Once the medical element is inserted through the device 100 and positioned in the body, the first locking member 118 can be locked by rotating the male component 200 with respect to the female component 210 to compress the male component 200 and engage the medical element extending therethrough. Although the male and female locking components 200, 210 are shown and described as having a threaded engagement, a person skilled in the art will appreciate that various techniques can be used to removably mate the male component 200 to the female component 210 such as a snap-fit, interference fit, or other removable engagement.

In another embodiment, the medical element can be secured by locking plates 302 disposed in the male component 300. As shown in FIG. 3, the locking plates 302 are positioned opposite each other in a longitudinally extending lumen or bore 320 formed in the male component 300 and can be formed from an elastic or compressible material to facilitate engagement of a medical element. The female component 310 can include a ramp portion 330 that is adapted to engage the locking plates 302 and bring the plates 302 into contact with the medical element extending therethrough. Similar to the embodiment described above, the male and female locking components 300, 310 are shown in FIG. 3 as having a threaded engagement. However, a person skilled in the art will appreciate that various techniques can be used to removably mate the male component 300 to the female component 310 such as a snap-fit, interference fit, or other removable engagement. In yet another embodiment, the male component can include an elastic diaphragm having a bore through its center. As the male component is received by the female component, the diaphragm can be compressed which is effective to tighten the diaphragm around the medical element extending therethrough.

As indicated above, and shown in FIG. 1, a protective sleeve 112 extends distally from the first locking member 118. The protective sleeve 112 can have a variety of configurations, but in one exemplary embodiment, the protective sleeve 112 is in the form of a flexible, tubular sheath. The protective sleeve 1 12 can be formed from any material suitable for preventing contamination of the medical element such as latex. The protective sleeve 112 can optionally be transparent to enable the user to view the medical element as it is passed through the device 100. As shown in FIG. I₃ a second locking member 114 can be disposed at the distal end of the protective sleeve 112 to minimize contamination of the implantable medical element. As with the first locking member 118, the second locking member 114 can be adapted to selectively engage a portion of the medical element. Providing the locking device 100 with a second locking member 114 allows the user to minimize contamination of the portion of the medical element disposed within the protective sleeve 112 thereby enabling repositioning and/or further advancement of the medical element if necessary. Various configurations can be used to selectively engage a portion of the implantable medical element. Each of the embodiments described above for the first locking member 118 can be used for the second locking member 114, and the first and second locking members 118, 114 need not have the same configurations. For example, in one exemplary embodiment the first locking member 118 can include a compressible male locking component 200 that is threadably received by a female locking component 210 and the second locking member can include a male locking component that is adapted to snap into a female locking component, the male locking component having an elastic diaphragm to engage a second portion the medical element extending therethrough. A person skilled in the art will appreciate that a number of different combinations are available for the first and second locking members 118, 114. Similar to the first locking member 118, the second locking member 114 can also include a guide tube 120 to steer the trajectory of the medical element. However, as shown in FIG. 1, the guide tube 120 associated with the second locking member 114 extends proximally from the second locking member 114 (i.e., towards the first locking member 118) instead of distally (i.e., towards the second locking member 114). A distal hub 122 can be coupled to the second locking member 114 to minimize contamination of the medical element and provide a sealed entry into the second locking member 114. The distal hub 122 can have various shapes and sizes, but one in exemplary embodiment, as shown in FIG. 1, the hub 122 is in the form of a cylinder having a longitudinal lumen extending therethrough and a sealed entry at a distal end. In another aspect of the invention, the locking device 100 can be provided as part of a kit for securing an implantable medical element. The kit can include a locking device 100 and an implantable medical element. As described above, various configurations are available for the locking device 100, but in one exemplary embodiment the locking device 100 can include a proximal locking component 110, a protective sleeve 1 12 extending distally from the proximal locking component 110, and a distal locking component 114 that is disposed at a distal end of the protective sleeve 112. The implantable medical element can also take a variety of forms. For example, in one exemplary embodiment the implantable medical element can be an electrical medical lead such as a temporary pacing electrode. In other embodiments, the implantable medical element can be, for example, a pulmonary artery catheter, a pulmonary arterial catheter, or a percutaneous ventricular assist device. Although the implantable medical element is described as various types of cardiac implants, a person skilled in the art will appreciate that any type of implantable medical element can be provided as part of the kit.

The present invention also provides methods for securing an implantable medical element or surgical lead. In one exemplary embodiment, an implantable electrical medical lead can be inserted into a locking device 100 that is positioned adjacent an entry port in a patient. The locking device 100 can have a proximal locking component 110, a protective sleeve 112 that extends distally from the proximal locking component 110, and a distal locking component 114 that is disposed at a distal end of the protective sleeve 112. The surgical lead can be advanced through the locking device 100 and into the patient's body. Once the lead is inserted into the body, it can be positioned at a desired location in the patient's heart. After the surgical lead is appropriately positioned in the patient's heart, the proximal and distal locking components 110, 114 of the locking device 100 can be locked or tightened to secure the surgical lead relative to an introducer for the lead. Because the portion of the surgical lead disposed within the protective sleeve 112 remains sterile, the surgeon can reposition the lead and further advance the lead into the patient's heart if necessary. Although the method is described as securing a surgical lead that is disposed in a patient's heart, a person skilled in the art will appreciate that the method can be used to secure any type of implantable medical element in any part of the patient's body. One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incoφorated herein by reference in their entirety. What is claimed is:

Claims

CLAIMS:

1. A locking device for an implantable medical element, comprising: a proximal locking component having a hub adapted to be attached to a portion of an introducer assembly for the implantable medical element and a first locking member selectively engageable to a first portion of the implantable medical element extending from a patient's body; a protective sleeve extending distally from the locking member of the proximal locking component; and a second locking member disposed at a distal end of the protective sleeve and selectively engageable to a second portion of the implantable medical element.

2. The device of claim I₃ wherein the first locking member comprises a male component adapted to be received by a female component.

3. The device of claim 2, wherein a portion of the male component is compressible and the female component is configured to compress the male component such that compressing the male component is effective to engage the medical lead.

4. The device of claim 3, wherein the compressible portion of the male component comprises an elastic diaphragm.

5. The device of claim 2, wherein the male component is threadably received by the female component.

6. The device of claim 1 , wherein the protective sleeve comprises a flexible sheath.

7. The device of claim 6, wherein the flexible sheath is transparent.

8. The device of claim 1 , wherein the distal locking component comprises a male component adapted to be received by a female component.

9. The device of claim 8, wherein a portion of the male component is compressible and the female component is configured to compress the male component such that compressing the male component is effective to engage the implantable medical element.

10. The device of claim 9, wherein the compress /ible portion of the male component comprises an elastic diaphragm.

11. The device of claim 8, wherein the male component is threadably received by the female component.

12. A kit for securing an implantable medical lead, comprising: a locking device having a proximal locking component, a protective sleeve extending distally from the proximal locking component, and a distal locking component disposed at a distal end of the protective sleeve; and an implantable medical lead.

13. The kit of claim 12, wherein the implantable medical lead comprises a temporary pacing electrode.

14. A method of securing a surgical lead, comprising: inserting an implantable electrical medical lead into a locking device positioned adjacent an entry port in a patient, the locking device having a proximal locking component, a protective sleeve extending distally from the proximal locking component,

,_. and a distal locking component disposed at a distal end of the protective sleeve; advancing the surgical lead through the locking device and into the patient's body; positioning the implantable electrical medical lead at a desired location in the patient's heart; and locking the proximal and distal locking components to thereby secure the surgical lead relative to an introducer for the implantable electrical medical lead.