CUSTOM LENGTH STYLET

Abstract

A custom length stylet assembly for meeting medical device length tolerances. The custom length stylet assembly including a stylet wire having a length extending between a distal end and a proximal end, stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, the stylet handle further defining a proximately positioned track and tab, the track configured to retain a bent proximal end portion of the stylet wire, the length of the stylet wire selected during assembly of the stylet assembly to conform to the corresponding length of a body implantable lead within a predefined tolerance, the tab of the stylet handle melted into the track, thereby securely fastening stylet wire to the stylet handle to inhibit rotation or dislodgement.

Claims

1. A stylet assembly for use in positioning a body implantable lead, the stylet assembly comprising: a stylet wire configured to extend through a lumen of the body implantable lead, the stylet wire having a length extending between a distal end and a proximal end; and a stylet handle configured to serve as a user grip for manipulation of the stylet wire, the stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, such that a distal portion of the stylet wire extends distally from a distal end of the stylet handle, the stylet handle further defining a proximately positioned track and tab, the track configured to retain a bent proximal end portion of the stylet wire; wherein the length of the stylet wire is selected during assembly of the stylet assembly to conform to a corresponding length of the body implantable lead within a predefined tolerance, and the tab of the stylet handle is meltable into the track, thereby securely fastening the stylet wire to the stylet handle and inhibiting rotation of the stylet wire relative to the stylet handle.

2. The stylet assembly of claim 1, wherein the stylet wire is constructed of a tungsten metal alloy.

3. The stylet assembly of claim 1, wherein the bent proximal end portion of the stylet wire includes a bend of between about 45 degrees and about 90 degrees.

4. The stylet assembly of claim 1, wherein the stylet wire is instructed of a stainless steel metal alloy.

5. The stylet assembly of claim 1, wherein the bent proximal end portion of the stylet wire includes a bend of between about 90 degrees and about 180 degrees.

6. The stylet assembly of claim 1, wherein the stylet handle is constructed of plastic.

7. The stylet assembly of claim 1, wherein the stylet handle includes an orientation member configured to provide a rotational orientation reference to a user during positioning of the body implantable lead.

8. The stylet assembly of claim 7, wherein the orientation member is a flat surface positioned on an otherwise cylindrical portion of the stylet handle.

9. The stylet assembly of claim 7, wherein the orientation member is a keyed member extending radially outward from a cylindrical portion of the stylet handle.

10. A lead kit for the insertion and positioning of an implantable neurostimulator lead into a body of a patient, the lead kit comprising: an implantable neurostimulator lead having a proximal end configured to be operably coupled to a medical device and a distal end configured to be positioned in communication with body tissue of the patient for electrical stimulation thereof, the implantable neurostimulator lead including an electrical conductor extending between the proximal end and the distal end of the implantable neuro stimulator lead, an electrode head affixed to the distal end having one or more electrodes in communication with the electrical conductor, the electrode head configured to be exposed to the body tissue for the supply of an electrical impulse thereto, and a body defining a longitudinally oriented lumen extending between the proximal end and a lumen termination point in proximity to the distal end; and a stylet assembly for use in positioning the implantable neurostimulator lead into the body of the patient, the stylet assembly including a stylet wire configured to extend through the lumen of the implantable neurostimulator lead, the stylet having a length extending between a distal end and a proximal end; and a stylet handle configured to serve as a user grip for manipulation of the stylet wire, the stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, such that a distal portion of the stylet wire extends distally from a distal end of the stylet handle, the stylet handle further defining a proximately positioned track and tab, the track configured to retain a bent proximal end portion of the stylet wire; wherein the length of the stylet wire is selected during assembly of the stylet assembly to conform to a corresponding length of the body implantable lead within a predefined tolerance, and the tab of the stylet handle is meltable into the track, thereby securely fastening the stylet wire to the stylet handle and inhibiting rotation of the stylet wire relative to the stylet handle.

11. The lead kit of claim 10, wherein the stylet wire is constructed of a tungsten metal alloy.

12. The lead kit of claim 10, wherein the bent proximal end portion of the stylet wire includes a bend of between about 45 degrees and about 90 degrees.

13. The lead kit of claim 10, wherein the stylet wire is instructed of a stainless steel metal alloy.

14. The lead kit of claim 10, wherein the bent proximal end portion of the stylet wire includes a bend of between about 90 degrees and about 180 degrees.

15. The lead kit of claim 10, wherein the stylet handle is constructed of plastic.

16. The lead kit of claim 10, wherein the stylet handle includes an orientation member configured to provide a rotational orientation reference to a user during positioning of the body implantable lead.

17. The lead kit of claim 16, wherein the orientation member is a flat surface positioned on an otherwise cylindrical portion of the stylet handle.

18. The lead kit of claim 16, wherein the orientation member is a keyed member extending radially outward from a cylindrical portion of the stylet handle.

19. A method of assembling a stylet assembly comprising: forming a stylet handle, the stylet handle defining a longitudinally oriented throughbore, a proximately positioned track, and a proximately positioned tab; bending a proximal end portion of the stylet wire; cutting a stylet wire to conform to a corresponding length of a body implantable lead within a predefined tolerance; positioning the stylet wire within the longitudinally oriented throughbore defined in the stylet handle, such that the bent proximal end portion of the stylet wire is retained within the track and a distal portion of the stylet wire extends distally from a distal end of the stylet handle; and melting the proximately positioned tab of the stylet handle into the proximately positioned track, thereby securely fastening the stylet wire to the stylet handle and inhibiting rotation of the stylet wire relative to the stylet handle.

20. The method of claim 19, wherein the bent proximal end portion of the stylet wire is bent to an angle of between about 90 degrees and about 180 degrees.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0012] The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:

[0013] FIG. 1 is a perspective view of a first embodiment of a stylet assembly, in accordance with the disclosure.

[0014] FIG. 2A is a profile view depicting the stylet assembly of FIG. 1.

[0015] FIG. 2B is a cross-sectional view depicting the stylet assembly of FIG. 2A.

[0016] FIG. 3A is a profile view depicting a stylet handle, in accordance with an embodiment of the disclosure.

[0017] FIG. 3B is cross-sectional view depicting the stylet handle of FIG. 3A.

[0018] FIG. 4 is a rear perspective view depicting the stylet handle of FIG. 3A.

[0019] FIG. 5 is a perspective view of a second embodiment of a stylet assembly, in accordance with the disclosure.

[0020] FIG. 6 is a cross-sectional view depicting the stylet assembly of FIG. 5.

[0021] FIG. 7A is a profile view depicting a stylet handle, in accordance with an embodiment of the disclosure.

[0022] FIG. 7B is a cross-sectional view depicting the stylet assembly of FIG. 7A.

[0023] FIG. 8 is a rear perspective view depicting the stylet handle of FIG. 7A.

[0024] FIG. 9 is a flowchart depicting a method of assembling a stylet assembly, in accordance with an embodiment of the disclosure.

[0025] While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION

[0026] Referring to FIG. 1, a custom length stylet assembly 100 for meeting medical device length requirements and tolerances, and which avoids manufacturing yield losses, is depicted in accordance with an embodiment. FIG. 1 further depicts a body implantable lead 200, which collectively with the stylet assembly 100 can be referred to as a lead kit 300. In other embodiments, a lead kit 300 may include one or more additional stylet assemblies and/or other components for aid in positioning the body implantable lead 200 to the tissue of a patient.

[0027] With additional reference to FIGS. 2A-B, in one embodiment, the stylet assembly 100 can include a stylet wire 102 and a stylet handle 104. The stylet wire 102 can include a body 106 extending between a distal end 108 and a proximal end 110 (as depicted in FIG. 2B). The stylet wire 102 can be constructed of a semi rigid, flexible wire, for example constructed of a tungsten or stainless steel alloy; although other wire construction materials are also contemplated. In some embodiments, the stylet assembly 100 can include a straight stylet wire 102 (as depicted in FIGS. 1-4). In other embodiments, the stylet assembly 100 can include one or more bends or angles defined in distal portion 108 of the stylet wire 102 (as depicted in FIGS. 5-8). A length of the stylet wire 102 can be selected to conform to a desired length. In one example, a length of the stylet wire 102 can be selected to conform to a corresponding length of the body implantable lead 200 within a predefined tolerance.

[0028] The body implantable lead 200 (depicted in FIG. 1) can be, for example, an implantable neurostimulator lead. The body implantable lead 200 can have a proximal end 202 and a distal end 204. The proximal end 202 can be configured to be operably coupled to a medical device, such as an implantable pulse generator. The distal end can be configured to be positioned in communication with body tissue of the patient for electrical stimulation thereof. In some embodiments, the body implantable lead 200 can further include one or more electrical conductors 206, electrode head 208 having one or more electrodes, and a body 210.

[0029] In some embodiments, the electrical conductor 206 can extend between the proximal end 202 and the distal end 204 of the body implantable lead 200. One or more electrodes can be affixed along the body of lead 200 and/or to the distal end 204, with appropriate with the electrical conductors 206 as needed. The electrode head 208 can be configured to be exposed to the body tissue of a patient for the supply of electrical impulses thereto. The body 210 can define a longitudinally oriented lumen extending between the proximal end 202 and a lumen termination point in proximity to the distal 204.

[0030] With additional reference to FIGS. 3A-B, the stylet handle 104 can be configured to serve as a user grip for manipulation of the stylet wire 102 during insertion and positioning of the body implantable lead 200 into a patient. The stylet handle 104 can define a longitudinally oriented throughbore 114 sized to retain a proximal portion 116 of the stylet wire 102, such that a distal portion 118 of the stylet wire 102 extends distally from a distal end 120 of the stylet handle 104. In some embodiments, the stylet handle 104 can further define a track 122 and a tab 124 (as further depicted in FIG. 4), positioned in proximity to a proximal end 126 of the stylet handle 104. In some embodiments, the stylet handle 104 can be constructed of plastic; although other construction materials are also contemplated.

[0031] In some embodiments, the stylet wire 102 can define a bent proximal portion 112. In one embodiment, the bent proximal end portion 112 has a substantially orthogonal bend of about 90. In another embodiment, the bent proximal end portion 112 has a U-shaped bend of about 180. Bend angles between about 0 and about 270 are also contemplated; for example, the bend can have an angle in the range of between about 45 and about 90, or in the range of between about 90 and about 180.

[0032] In some embodiments, the track 122 of the stylet handle 104 can be shaped and sized to retain the bent proximal end portion 112 of the stylet wire 102, when the stylet wire 102 is positioned within the longitudinally oriented throughbore 114 defined in the stylet handle 104, thereby inhibiting rotation of the stylet wire 102 relative to the stylet handle 104. In some embodiments, the tab 124, which can be positioned in close proximity to the track 122, can be melted, re-melted, reflowed or otherwise reformed to fill in the void within the track 122 surrounding the bent proximal end portion 112, thereby securely fastening the bent proximal end portion 112 within the track 122. For example, in one embodiment, the tab 124 can be melted via a soldering iron or other similar device.

[0033] In some embodiments, the stylet handle 104 can include one or more orientation members 128 configured to provide a rotational orientation reference to a user during manipulation and positioning of the body implantable lead 200 into a patient. In one embodiment, the orientation member 128 can be a flat surface 130 positioned on an otherwise cylindrical portion 132 of stylet handle 104. For example, in some embodiments, the stylet handle 104 can include a pair of opposed flat surfaces 130A/130B (as depicted in FIGS. 1-4) as an aid providing a rotational orientation reference during use.

[0034] In other embodiments, the orientation member 128 can be in the form of a keyed member 134 extending radially outward from a cylindrical portion 132 (as depicted in FIGS. 5-8). In some embodiments, the keyed member 134 can be opposite a flat surface 130 on the otherwise cylindrical portion 132 of the stylet handle 104. In some embodiments, keyed member 134 can act as an aid providing a rotational orientation reference during use.

[0035] Additionally, embodiments of orientation members 128 can also advantageously prevent unintended slippage or rotation of stylet 100, 100 in a hand of a user grasping the stylet handle 104, such as when applying a rotational torque during use of stylet 100, 100.

[0036] In further embodiments, stylet 100 and/or 100 can be provided in, or with, a lead kit 300, which can further include a body implantable lead 200. For example, the kit 300 can comprise at least one custom length stylet device 100, and/or at least one custom length stylet device 100. Kit 300 may be provided in whole or in part in sterile packaging, and the kit 300 can also include one or more instructions for assembly, instructions for use, the medical device which stylet 100 will be used in conjunction with, or other components configured to support user understanding of custom length stylet device 100.

[0037] Referring to FIG. 9, a method 400 of assembling a stylet assembly 100, 100 is depicted in accordance with an embodiment of the disclosure. At 402, the stylet assembly 100, 100 can be assembled by forming a stylet handle 104 defining a longitudinally oriented through bore 114, a proximally positioned track 122, and a proximally positioned tab 124. At 404, a proximal portion 116 of the stylet wire 102 can be bent to form a bent proximal end portion 112. At 406, the stylet wire 102 can be cut to conform to a desired length, such as to corresponding to a length of a body implantable lead 200 within a predefined tolerance. At 408 proximal end portion 112 can be positioned within the track 122, such that the stylet wire 102 is positioned within the throughbore 114 and a distal portion 118 of the stylet wire 102 extends distally from a distal end 120 of the stylet handle 104. At 410, the tab 124 can be melted into the track 122, thereby securely fastening the stylet wire 102 to the stylet handle 104 and inhibiting rotation of the stylet wire 102 relative to the stylet handle 104, and thus creating stylet 100, 100 of the desired length.

[0038] It should be understood that the individual steps used in the methods of the present teachings may be performed in any order and/or simultaneously, as long as the teaching remains operable. Furthermore, it should be understood that the apparatus and methods of the present teachings can include any number, or all, of the described embodiments, as long as the teaching remains operable.

[0039] In general throughout this document, and unless otherwise noted, proximal is used to refer to an end or portion that is closest to the user of the device and the bent portion of the wire, and distal is used to refer to an end or portion that is furthest from the user of the device.

[0040] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0041] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0042] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term processor as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.