MEDICAL DEVICE SYSTEM AND APPARATUS FOR GUIDING THE PLACEMENT OF A SUBCUTANEOUS DEVICE
A medical device system for guiding placement of a subcutaneous medical device that includes a strap extending along a length from a proximal end to a distal end, a first flange and a second flange extending along a portion of the length of the strap, a base portion extending along a portion of the length of the strap between the first flange and the second flange, an orientation member extending along the strap to limit a predetermined radius of curvature of the strap, and an indentation extending from the proximal end to the distal end of the strap, the indentation formed by the first flange, the second flange, and the base portion, wherein the first flange and the second flange include curved bottom portions that make contact with and compress a tissue layer to position the tissue layer within the indentation during the placement of the subcutaneous device.
Latest Patents:
- FOOD BAR, AND METHOD OF MAKING A FOOD BAR
- Methods and Apparatus for Improved Measurement of Compound Action Potentials
- DISPLAY DEVICE AND MANUFACTURING METHOD OF THE SAME
- PREDICTIVE USER PLANE FUNCTION (UPF) LOAD BALANCING BASED ON NETWORK DATA ANALYTICS
- DISPLAY SUBSTRATE, DISPLAY DEVICE, AND METHOD FOR DRIVING DISPLAY DEVICE
This application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/116,492, filed Nov. 20, 2008, entitled, “Apparatus for Guiding The Placement of a Subcutaneous Device”, and to U.S. Provisional Application Ser. No. 61/190,052, filed Jul. 31, 2008, entitled, “Apparatus for Guiding The Placement of a Subcutaneous Device” the contents of which are incorporated by reference herein in its entirety.
CROSS-REFERENCE TO RELATED APPLICATIONSCross-reference is hereby made to the commonly assigned related U.S. Applications, Attorney Docket Number P0033646.00, entitled “MEDICAL DEVICE SYSTEM AND APPARATUS FOR GUIDING THE PLACEMENT OF A SUBCUTANEOUS DEVICE”, to Havel et al.; and Attorney Docket Number P0035525, “MEDICAL DEVICE SYSTEM AND APPARATUS FOR GUIDING THE PLACEMENT OF A SUBCUTANEOUS DEVICE”, to Havel et al., and Attorney Docket Number P0021671.01, entitled “APPARATUS FOR GUIDING THE PLACEMENT OF A SUBCUTANEOUS DEVICE” to Havel et al.; filed concurrently herewith and incorporated herein by reference in their entireties.
FIELD OF THE INVENTIONThe present disclosure relates to subcutaneous medical devices, and in particular, to an apparatus and medical device system for subcutaneously advancing a subcutaneous device to a desired implant site during an implantation procedure.
BACKGROUND OF THE INVENTIONA subcutaneous device, such as a coil electrode for an implantable cardioverter-defibrillator (ICD) positioned along a lead body, is typically implanted in a patient while the patient is lying supine on his or her back. The subcutaneous device is implanted using a tunneling tool that provides enough stiffness and pushability to create a space between the subcutaneous and muscular plane. However, since the patient is typically positioned on his or her back, it is difficult for a physician to maneuver a tunneling tool around the curvature of the posterior axilla to continue tunneling from the axilla to the spine.
One potential problem that a physician may encounter while implanting a subcutaneous device using a tunneling tool relates to the tendency of the tunneling tool to turn inward, between the ribs and into muscle of the patient, potentially creating a pneumothorax. In addition, the tunneling tool may also have a tendency to turn outward, potentially puncturing the skin. In order to prevent the tunneling from turning outward, a non-sterile scrub nurse places a hand under the patient's back to help guide the tunneling tool and to give the skin support so that the tunneling tool does not penetrate the skin. In addition, x-ray or other suitable imaging systems may need to be utilized to help guide the tunneling tool to the desire location.
Therefore, a need exists for an improved apparatus to subcutaneously tunnel a device to a desired implant site during an implantation procedure.
Apparatus 100 is positioned over the appropriate intercostal space from the mid-axilliary line to the spine of a patient. Apparatus 100 is then attached to the patient. Indentation 104 allows a fold of skin and fat layer of the patient to compress into indentation 104 or to be positioned within indentation 104 when the patient lies down on an operating table. Indentation 104 provides a mechanical guide for a tunneling tool during the placement of a subcutaneous device, such as a coil electrode or lead. Indentation 104 also provides for more precise placement of the subcutaneous device compared to typical methods. In addition, apparatus 100 holds the skin taut so that the skin does not fold or snag during tunneling. Apparatus 100 replaces the need to have a hand over the top of the patient's skin or the need to use x-ray or other imaging systems to assist the physician in guiding the tunneling tool.
Strap 102 is made of a semi-stiff material such that strap 102 conforms to a patient's body yet is sufficiently rigid to enable a fold of skin and fat layer of the patient to be compressed into indentation 104 with strap 102 attached to the patient. In one embodiment, strap 102 is made of plastic that has sufficient flex to conform to a patient's body. In another embodiment, strap 102 is made of rubber. In other embodiments, strap 102 is made of other suitable materials or combinations of materials. In one embodiment, strap 102 is approximately 12 to 18 inches long. In one embodiment, strap 102 can be sterilized.
In one embodiment, strap 134 is attached to patient 130 such that end 136 of strap 134 is at the desired location for the placement of a subcutaneous device. In one embodiment, strap 134 includes a mark or marks 138 for indicating how far a tunneling tool should be inserted to reach the desired location for the placement of a subcutaneous device at end 136 of strap 134. The distance between end 136 of strap 134 and mark or marks 138 is indicated at 140.
In one embodiment, a hollow channel or channels 204 are provided along the length of strap 102 through material 202. In another embodiment, channels 204 are provided through strap 102. After apparatus 200 is attached to a patient, a tunneling tool can be inserted into a channel 204 to shape the tunneling tool to conform to the patient's body prior to inserting the tunneling tool into the patient's body.
Voltage source 230 provides a voltage between electrode 212 and tunneling tool electrode 222. Ammeter 226 measures the current between electrode 212 and tunneling tool electrode 222. As the impedance between electrode 212 and tunneling tool electrode 222 increases, the current indicated by ammeter 226 between electrode 212 and tunneling tool electrode 222 decreases. As the impedance between electrode 212 and tunneling tool electrode 222 decreases, the current indicated by ammeter 226 between electrode 212 and tunneling tool electrode 222 increases. Therefore, by monitoring the current indicated by ammeter 226, the depth of tunneling tool 220 beneath the patient's skin can be determined. In this embodiment, tunneling tool 220 is in the desired space between cutaneous tissue 172 and muscle 174. As such, the needle of ammeter 226 is centered indicating that tunneling tool 220 is in the desired space. In other embodiments, ammeter 226 is replaced with a digital meter or other suitable monitor for indicating the impedance between electrode 212 and tunneling tool electrode 222.
Voltage source 230 provide a voltage between reference electrode 256 and tunneling tool electrode 222. Bipole electrode 254 provides a target location for a subcutaneous device. Voltmeter 260 indicates the position of tunneling tool electrode 222 based on the polarity indicated by the needle of voltmeter 260. In this embodiment, tunneling tool 220 has not yet reached the target location. As such, the needle of voltmeter 260 is to the right indicating a positive polarity. Therefore, the physician should continue to advance tunneling tool 220 toward the target location.
In one embodiment, the first and second impedance measurements provide an electrical guide for assisting a physician in guiding the tunneling tool during placement of a subcutaneous device. The first and second impedance measurements provide an indication of the lateral position of the tunneling tool between first electrode 272 and second electrode 274. As the tunneling tool moves toward first electrode 272, the impedance between first electrode 272 and the tunneling tool decreases and the impedance between second electrode 274 and the tunneling tool increases. As the tunneling tool moves toward second electrode 274, the impedance between second electrode 274 and the tunneling tool decreases and the impedance between first electrode 272 and the tunneling tool increases.
For example, if it is desired that the handle 408 be positioned perpendicular to the strap 402, the threaded screw member 422 of handle 408 is positioned within threaded port 420 of third side wall 414. If it is desired that the handle 408 be positioned parallel to the strap 402, the threaded screw member 422 of handle 408 is positioned within threaded port 416 of first side wall 410. If it is desired that the handle 408 be position at an angle other than perpendicular or parallel to the strap 402, the threaded screw member 422 of handle 408 is positioned within threaded port 418 of second side wall 412. In this way, the handle 408 may be detachably removed and positioned to be in any of the available orientations as desired.
The apparatus of
Each of the first and second ends 524 and 526 are formed to have a first angled portion 531 extending at a predetermined angle between the hinge member 522 and a bottom side 532 of the segment 520, and a second angled portion 533 extending at a second predetermined angle between the hinge member 522 and a top side 534 of the segment 520. The first and second predetermined angles are chosen to limit the radius of curvature of the orientation member 500 to a value associated with the greatest radius of curvature that can be tolerated before making advancing of the tunneling tool 150 through the strap 502 difficult. In this way the orientation member 500 can be advanced between a first position in which adjacent first angled portions 531 are engaged, to a straight position in which the first and second angled portions 531 and 533 are all equally relatively spaced (shown in
While the orientation member 500 is shown utilizing hinge members 522 to limit the orientation of the strap 502, it is understood that other designs may be utilized to limit the orientation of the strap 502, such the use of a material having a desire limited flexion corresponding to the desired limited radius of curvature. Furthermore, while the orientation member is describe being utilized in the strap having the curved flanges, the orientation member may also be utilized in the strap having the straight flanges described above and shown in
One or more flexpoints 612 are formed along the straps 610 and 612, such as along proximal ends 615 of the straps 610 and 612 to allow for adjustment of a spacing angle between the two straps 610 and 612. In the alternative, a hinge member may be utilized to facilitate the variable separation of the two straps 610 and 612.
Embodiments provide an apparatus for assisting a physician in the placement of a subcutaneous device, such as a coil electrode for an implantable cardioverter-defibrillator (ICD) or other suitable subcutaneous device. The apparatus comprises a strap including an indentation for providing a mechanical guide for a tunneling tool. In addition, embodiments provide an electrical guide for assisting a physician in the placement of a subcutaneous device. The electrical guide is based on an impedance measurement or measurements between an electrode on a tunneling tool and an electrode or electrodes on the patient's skin. Embodiments also provide combinations of the mechanical guide and the electrical guide.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present invention.
Claims
1. A medical device system for guiding placement of a subcutaneous medical device comprising:
- a tunneling tool to form a space between the a first plane of tissue and a second plane of tissue for positioning the subcutaneous medical device;
- a strap extending along a length from a proximal end to a distal end to guide the tunneling tool between the first and second plane of tissue;
- an orientation member extending along the strap to limit a predetermined radius of curvature of the strap.
2. The medical device system of claim 1, wherein the predetermined radius of curvature corresponds to a portion of the strap that is advanced along a patient's side to the spine of the patient.
3. The medical device system of claim 1, wherein the orientation member comprises:
- a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;
- a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.
4. The medical device system of claim 3, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.
5. The medical device system of claim 4, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.
6. A medical device system for guiding placement of a subcutaneous medical device comprising:
- a strap extending along a length from a proximal end to a distal end
- a first flange and a second flange extending along a portion of the length of the strap;
- a base portion extending along a portion of the length of the strap between the first flange and the second flange;
- an orientation member extending along the strap to limit a predetermined radius of curvature of the strap; and
- an indentation extending from the proximal end to the distal end of the strap, the indentation formed by the first flange, the second flange, and the base portion, wherein the first flange and the second flange include curved bottom portions that make contact with and compress a tissue layer to position the tissue layer within the indentation during the placement of the subcutaneous device.
7. The system of claim 6, wherein the orientation member is positioned in one of the first flange and the second flange.
8. The medical device system of claim 6, wherein the orientation member is positioned in the base portion.
9. The medical device system of claim 6, wherein the orientation member comprises:
- a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;
- a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.
10. The medical device system of claim 9, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.
11. The medical device system of claim 10, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.
12. The medical device system of claim 11, wherein the indentation is formed by a first sidewall portion of the first flange, a second sidewall portion of the second flange positioned opposite the first sidewall portion, and a bottom wall of the base portion extending between the first sidewall portion and the second sidewall portion, wherein the first sidewall portion and the second sidewall portion have curved portions extending within the indentation.
13. The medical device system of claim 11, further comprising:
- a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and
- a conductive surface along the base portion of the indentation for measuring an impedance between the first conductive surface and the tip of the tunneling tool to provide a depth of the tip of the tunneling tool beneath the first plane of tissue.
14. The medical device system of claim 11, further comprising:
- a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue; and
- a first conductive surface along the first flange for measuring a first impedance between the first conductive surface and the tip of the tunneling tool; and
- a second conductive surface along the second flange for measuring a second impedance between the second conductive surface and the tip of the tunneling tool, wherein the first impedance and the second impedance provide a lateral position of the tip of the tunneling tool between the first conductive surface and the second conductive surface.
14. The medical device system of claim 11, further comprising:
- a tunneling tool having a tip to form a space between a first plane of tissue and a second plane of tissue;
- a first electrode positioned along the base portion;
- a second electrode positioned along the first flange;
- a third electrode positioned along the second flange; and
- a fourth electrode positioned along the tip of the tunneling tool, wherein a first impedance measurement between the first electrode and the fourth electrode provides a depth of the tip beneath the first plane of tissue, and wherein a second impedance measurement between the second electrode and the fourth electrode and a third impedance measurement between the third electrode and the fourth electrode provide a lateral position of the tip between the second electrode and the third electrode.
15. The medical device system of claim 11, further comprising:
- a tunneling tool to form a space between a first plane of tissue and a second plane of tissue;
- a first mark positioned along the strap; and
- a second mark positioned along the tunneling tool, wherein the first mark is configured to be aligned with the second mark to indicate a location for placement of the tunneling tool.
16. The medical device system of claim 11, further comprising a tunneling tool to form a space between a first plane of tissue and a second plane of tissue, wherein the strap comprises a bipole electrode configured to indicate a location for placement of the tunneling tool.
17. A medical device system for guiding placement of a subcutaneous medical device comprising:
- a strap extending along a length from a proximal end to a distal end
- a first flange and a second flange extending along a portion of the length of the strap;
- a base portion extending along a portion of the length of the strap between the first flange and the second flange;
- a handle orientation member positioned at the proximal end of the strap; and
- a handle capable of being selectively positioned at one of a plurality of orientations along the handle member;
- an orientation member extending along the strap to limit a predetermined radius of curvature of the strap; and
- an indentation extending from the proximal end to the distal end of the strap, the indentation formed by the first flange, the second flange, and the base portion, wherein the first flange and the second flange include curved bottom portions that make contact with and compress a tissue layer to position the tissue layer within the indentation during the placement of the subcutaneous device.
18. The medical device system of claim 17, wherein the orientation member comprises:
- a plurality of adjacent segments, each of the plurality of segments extending from a first end to a second end;
- a plurality of interconnecting members, each of the plurality of interconnecting members positioned between the first end of one segment of the plurality of segments and the second end of another segment of the plurality of segments adjacent to the one segment of the plurality of segments.
19. The medical device system of claim 18, wherein each segment of the plurality of segments include a first angled portion extending at a first predetermined angle between an interconnecting member of the plurality of interconnecting members and a bottom side, and a second angled portion extending at a second predetermined angle between the interconnecting member and a top side.
20. The medical device system of claim 19, wherein the orientation member is advanced between a first position corresponding to adjacent first angled portions being engaged, a second position corresponding to adjacent first and second angled portions being equally relatively spaced, and a third position corresponding to adjacent second angled portions being engaged.
Type: Application
Filed: Apr 29, 2009
Publication Date: Feb 4, 2010
Applicant:
Inventors: William J. Havel (Maple Grove, MN), Vladimir P. Nikolski (Blaine, MN), Matthew D. Bonner (Plymouth, MN)
Application Number: 12/432,052
International Classification: A61B 17/32 (20060101);