WO2019147833A1

WO2019147833A1 - Lead deployment apparatus and method therefor

Info

Publication number: WO2019147833A1
Application number: PCT/US2019/014980
Authority: WO
Inventors: John O'mahony
Original assignee: Stimdia Medical Inc
Current assignee: Stimdia Medical Inc
Priority date: 2018-01-25
Filing date: 2019-01-24
Publication date: 2019-08-01
Anticipated expiration: 2020-07-25

Abstract

Aspects of the disclosure are directed to apparatuses and methods involving positioning of a lead with a needle component and clamp piston assembly. As may be implemented in accordance with one or more embodiments, a needle component has a housing, a needle tip, and an opening therein extending through the housing and tip and being configured to pass a lead therethrough. A clamp piston assembly is coupled to the needle component and also has an opening therein configured to pass the lead therethrough. The clamp piston assembly is configured and arranged with the needle component to move relative to one another while the lead passes therethrough, and to fix the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston.

Description

LEAD DEPLOYMENT APPARATUS AND METHOD THEREFOR

FIELD

Aspects of the present disclosure involve and/or relate to a lead deployment apparatus.

BACKGROUND

The deployment of flexible leads can be useful for a variety of applications, including medical applications in which such a lead is implanted into a patient for applying electrical stimulation. Certain flexible leads employ through the needle (TTN) catheter deployment, which may be used for a variety of applications such as local nerve anesthesia, intravenous therapy, lumbar punctures and spinal cord stimulation. However, such flexible leads may buckle under compression forces as may result from a user manually retracting the needle while pushing on the flexible lead. Further, lead deployment position at an original needle insertion depth before retraction may be challenging to obtain, particularly if the lead has a buckling strength less than compression forces generated by the needle and retraction forces generated by the extrusion of the lead through the needle.

Certain lead deployment devices utilize a stiffening member such as a stylet that feeds through a center of catheter or lead. Such a stylet may temporarily increase the buckling strength while in place, and may prevent the lead from buckling during device insertion or needle retraction. The temporary stylet/stiffening member is then removed after the lead or catheter is deployed. The use of a stylet may increase the required lead diameter in order to attain desired buckling strength, which may be undesirable for applications in which smaller dimensions are beneficial. As a result, properly-sized stylets may provide inadequate stiffening support. Further, using a temporary stylet also uses up valuable cross-sectional area which could be used to enhance the product. Furthermore, while buckling strength of leads can be increased, this may increase the potential that such leads may harm tissue in which the lead is deployed.

These and other matters have presented challenges to the design and implementation of apparatuses, systems and methods involving lead deployment. SUMMARY

Various aspects of the present disclosure are directed to apparatuses, methods and systems involving lead deployment, in a manner that addresses challenges and limitations including those discussed above.

Certain specific aspects are directed to lead deployment, in which respective portions of a deployment device operate for penetrating into a material, such as tissue or a vessel, to a target depth, placement of a lead at that depth, and retraction of the penetrating component while fixing the lead in place. This may, for example, be carried out with a needle and piston assembly, with the needle effecting penetration and initial placement of the lead extending therethrough, and the piston assembly facilitating fixation of the lead in place while the needle component is retracted around the lead.

As may be implemented in accordance with one or more embodiments, a needle component has a housing, a needle tip, and an opening therein extending through the housing and tip and being configured to pass a lead therethrough. A clamp piston assembly is coupled to the needle component and also has an opening therein configured to pass the lead therethrough. The clamp piston assembly is configured and arranged with the needle component to move relative to one another while the lead passes therethrough, and to fix the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston.

As may be implemented in accordance with a particular method-based embodiment, a method involves passing a lead through a needle component and a clamp piston assembly in which the needle component has a housing and a needle tip, and an opening therein extending through the housing and tip and being configured to pass the lead. The clamp piston assembly is coupled to the needle component and has an opening therein configured to pass the lead therethrough. The lead is fixed in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston assembly.

The above summary is not intended to describe each embodiment or every implementation of the present disclosure. The figures and detailed description that follow more particularly exemplify various embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may 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:

Figure 1.0 Shows a lead deployment device, as may be implemented in accordance with one or more embodiments;

Figure 2.0 shows a lead as may be deployed by a lead deployment device, implemented in accordance with one or more embodiments;

Figure 3.0 shows a cross-section of a needle with a lead placed at the tip and a deployment route of the needle during needle retraction, as may be implemented in accordance with one or more embodiments;

Figure 4.0 shows a lead tip, as may be implemented in accordance with one or more embodiments;

Figure 5.0 shows a front and end view of a clamp piston with lead bore, as may be implemented in accordance with one or more embodiments;

Figure 6.0 shows a front and end view of a retention guard, as may be implemented in accordance with one or more embodiments;

Figure 7.0 shows a front and end view of a compression seal, as may be implemented in accordance with one or more embodiments;

Figure 8.0 shows a front and end view of a compression valve, as may be implemented in accordance with one or more embodiments;

Figure 9.0 shows a sequence of steps for performing clamp and needle retraction action to deploy a lead in place of a retracted needle, as may be implemented in accordance with one or more embodiments;

Figure 10.0 shows a cross-section of a lead deployment device, as may be implemented in accordance with one or more embodiments; and

Figure 11.0 shows elevation and end view of a duck bill seal, as may be implemented in accordance with one or more embodiments. While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and 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 scope of the disclosure including aspects defined in the claims.

DETAILED DESCRIPTION

Various aspects of the disclosure relate to flexible leads and their deployment. As may be implemented in accordance with various embodiments, a lead or other component being deployed is configured or otherwise implemented for exhibiting variable stiffness. This stiffness can be imparted, for example, during deployment of a lead within a patient, addressing challenges such as those characterized above. In particular applications, a needle- type deployment is implemented by utilizing a needle to insert a lead into a patient, stiffening the lead and withdrawing the needle, leaving the lead in place. The lead stiffness can be relaxed after insertion, allowing the lead to readily flex and, therein, further addressing issues including those characterized herein. While the present disclosure is not necessarily limited to such applications, various aspects of the disclosure may be appreciated through a discussion of examples using this context.

In certain embodiments, systems and/or methods involve temporarily providing stiffness or other support to a lead or device being deployed (e.g., implanted) with a needle, during retraction of the needle, while maintaining a catheter or lead position with respect to the original needle insertion depth. Such an approach may also be carried out without the use of a stylet. As used in this instance and otherwise, the term lead may refer to a pacing lead, a sensor embedded in a lead, or another device that can be deployed through a needle. In some contexts, a lead refers to a catheter device.

In accordance with a particular exemplary embodiment, a lead device includes a sliding piston configured to stiffen the lead, and a clamp mechanism is configured to grip the lead while the needle is being retracted through a second concentric stiffening member, which may be referred to as a lead guide. In certain implementations, this sliding action between the piston and lead guide facilitates a one to one relationship between the retracted distance of the needle and lead deployment distance from the tip of the needle.

Another exemplary embodiment is directed to a lead deployment device having a spring within a piston bore, which is configured to return a clamp piston member to a predetermined position, after retraction of a needle at the end of the stroke thereof, releasing the clamp piston. The spring forces the piston back to an extended position once the clamping action is released. The stroke distance may be set as large or as small in length as desired, and may be ergonomically set as a function of the depth of the needle, the overall length of the lead deployment device and the care required by a user during needle retraction. The lead deployment device length may be twice the length of the piston stroke. In another exemplary embodiment, a lead deployment device includes a coupler that couples a catheter to another component, such as a Tuohy Borst Valve configured to clamp the lead in place. A cutout is located in a slide and a silicone mbber ring clamps the lead in place, due to constmction of a screwing clamp mechanism.

In another exemplary embodiment, a lead deployment device has slots in a stiff polymer disk that facilitate a priming function for inserting a needle (e.g., which may be carried out while a Tuohy Borst Valve as noted above is closed).

Certain embodiments are directed to mitigating positional slippage between lead depth and original needle depth, by utilizing a 1 : 1 relationship between lead deployment and needle retraction. This can be achieved by enclosing a flexible lead in a stiff tube, such that bucking is no longer possible during needle retraction and by providing a mechanism that ensures the needle retraction results in a 1:1 ratio between a needle retraction stroke and deployment of the lead. The piston action is used to extmde the lead into the former position of the needle as the needle is retracted.

As may be implemented in accordance with one or more embodiments, a needle component has a housing, a needle tip, and an opening therein extending through the housing and tip and being configured to pass a lead therethrough. A clamp piston assembly is coupled to the needle component and also has an opening therein configured to pass the lead therethrough. The clamp piston assembly is configured and arranged with the needle component to move relative to one another while the lead passes therethrough, and to fix the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston. Certain embodiments also include the lead.

In some embodiments, the needle component is configured and arranged for insertion to a depth within a material, and the clamp piston assembly is configured and arranged with the needle component to clamp the lead in place with the needle tip extended to the depth within the material. The clamp piston assembly and needle component are further configured to slide linearly relative to one another as the needle component is retracted from the material, while maintaining the lead tip fixed in place at the depth within the material.

Where the material is tissue, the needle component may thus puncture the tissue and extend the needle tip to a desired depth within the tissue, with a tip of the lead extending into the needle tip. In this context the lead may be deployed before, during or after insertion of the needle tip. Further, the clamp piston assembly may slide relative to the needle component as the needle component is retracted from the tissue while maintaining the lead tip fixed in place within the tissue. This facilitates placement of the lead to the desired depth at which the needle tip is placed, and mitigates unintended or undesirable retraction of the lead tip while the needle tip is retracted.

Certain embodiments further employ a spring component that applies a spring force to maintain the clamp piston assembly in a fixed relative position relative to the needle component. The spring is responsive to an external force that causes relative movement between the clamp piston assembly and the needle component that applies a force to the spring, by facilitating movement of the clamp piston assembly and the needle component toward one another. The spring is also responsive to the external force being released by causing the clamp piston assembly and needle component to move relatively away from one another toward the fixed relative position.

In some embodiments, the lead includes a flexible conductor, and the needle component and clamp piston assembly are configured to maintain a portion of the flexible lead extending within the needle component and clamp piston assembly in a linear arrangement. Such an approach facilitates insertion of the lead in a manner that imparts desired stiffness to facilitate the insertion, while allowing the lead to flex after implantation.

The clamp piston assembly may be implemented in a variety of manners. In some embodiments, the clamp piston assembly includes a cylindrical shell that passes the lead through an inner sidewall thereof. At a portion of the cylindrical shell, a lead clamp component is operable to deflect and clamp the lead in response to an applied force to an outer sidewall of the cylindrical shell. The lead clamp component may include a portion of the sidewall having an opening therein and a cantilever-type portion of the cylindrical shell adjacent the opening and that is configured and arranged to deflect and clamp the lead.

The needle component may be implemented in a variety of manners. In some embodiments, the needle component has a housing configured to accept the clamp piston assembly therein. The clamp piston assembly has a piston head that is configured with the housing to slide linearly within the housing with an outer surface of the piston head facing an inner surface of the housing. As such, the respective surfaces may be configured with one another to maintain alignment of the housing and the clamp piston assembly. This may involve, for example, a close fit that allows sliding engagement.

As may be implemented in accordance with a particular method-based embodiment, a method involves passing a lead through a needle component and a clamp piston assembly in which the needle component has a housing and a needle tip, and an opening therein extending through the housing and tip and being configured to pass the lead. The clamp piston assembly is coupled to the needle component and has an opening therein configured to pass the lead therethrough. The lead is fixed in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston assembly. Clamping the lead in place may involve, for example, applying pressure to a portion of the clamp piston assembly and therein causing the portion of the clamp piston assembly to deflect and clamp the lead relative to the clamp piston assembly.

In various embodiments, the needle component may be inserted with the needle tip extending to a depth within a material, and the lead component is positioned within the needle component and extending to the needle tip. This positioning may be effected prior to, after or during insertion of the needle tip. The lead is fixed in place relative to the clamp piston assembly while the needle component moves by clamping the lead to the clamp piston and holding the clamp piston in place relative to the material, while withdrawing the needle component from the material by moving the needle component toward the clamp piston assembly as it is being retracted over the lead in the material. In certain applications, the material is tissue (e.g., of a patient), and the needle component and the clamp piston assembly are slid off the lead while the lead remains in place within the tissue and at the depth to which the needle component was extended, after the needle component has been withdrawn from the tissue.

In some embodiments a spring force is applied to maintain the clamp piston assembly in a fixed relative position relative to the needle component. In response to an external force that causes relative movement between the clamp piston assembly and the needle component that applies a force to the spring (e.g., a user or mechanical actuator applying a force), the clamp piston assembly and the needle component are moved toward one another. In response to the external force being released, the spring force is used to move the clamp piston assembly and needle component relatively away from one another toward the fixed relative position.

In accordance with a further embodiment, the lead is fixed in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by sliding a piston head of the clamp piston assembly within a housing of the needle component. In this context, the housing may have an inner surface configured to accept the clamp piston assembly therein with an outer surface of the piston head interfacing therewith to maintain alignment of the housing and the clamp piston assembly. For instance, where the inner housing surface is cylindrical and the piston head is cylindrical, the two may slide relative to one another with a tolerance-type fit.

Turning now to the figures, Figure 1.0 shows a cross-section along the centerline of an exemplary embodiment of a lead deployment device 100, includes a needle 101 (e.g., a Touhy-tipped needle) with a lead 102 running through the center of the lead deployment device. The lead deployment device includes a clamp piston 104 with a clamp region 105 at one end and a piston head 106 at the other end. The clamp region 105 has a slot 130, providing respective cantilevers that may be depressed (e.g., by an operators’ index finger and thumb) to clamp on the lead. A spring force is applied via compression spring 107 to ensure that the clamp piston 106 is fully extended when not under external forces. The clamp piston 106 is configured to slide over the slide rod 108. The slide rod 108 may be fixed in place by compression valve 109 at point 110. Fixing the position at 110 of the lead in the compression valve ensures there is no space for the flexible lead 102 to bend between the needle hub 101 and the end of the slide rod 108. The clamp piston 104 is also contained within a cylinder bore containing the compression spring and the piston head 106 of the clamp piston 104. The piston rod may be made from an injection molded polymer or metal.

The lead deployment device 100 may be implemented in a variety of manners. For instance, the needle 101 may be inserted subcutaneously to a depth in tissue 103 (e.g., of a patient) and the lead can be deployed accordingly. In such a use-case scenario, a needle tip 131 can be used to puncture a surface of the tissue 103 and plunge therein, carrying an end of the lead

102 with it. Once the needle (with lead therein) is implanted to a desired depth, the clamp region 105 can be manipulated to clamp onto the lead 102 as facilitated by the slot 130. The needle tip 131 can then be withdrawn from the patient while the lead is clamped, with the clamp piston 104 (and piston head 106) and the needle tip 131 moving relatively toward one another against the force of the spring 107. Once the needle tip 131 is withdrawn from the tissue (at least partially), the clamp region 105 can be released and the lead deployment device 100 may be slid off of the lead 102, with the lead remaining implanted in the tissue

103 at (or very close to) the original depth to which the needle has been inserted.

In some embodiments, the lead deployment device 100 includes an additional Tuohy Borst clamp that allows the lead deployment device to lock the lead 102 in position if so desired. The Tuohy Borst clamp includes the compression valve 109, compression seal 112, support disk 113, retention guard 114 and rotation grips 115. The retention guard is configured to allow the rotation grips 115 to pass through clearance gap 121. The compression seal is compressed by rotating the rotation grips clockwise and via a screw thread 116 the compression valve 109 compresses the compression seal. This seal is bounded by the body 117 of the lead deployment device 100, the slide rod, and the support disk forcing the seal 112 to expand into groove slots in the slide rod, clamping the lead within the slide rod. Rotating the compression valve counter clockwise releases the compression forces. In order to prevent the compression valve from being unscrewed fully, a retention guard 114 may be used to limit the travel.

In certain embodiments, the lead deployment device 100 includes a luer 118 via which saline may be infused. This may be achieved using a syringe filled with saline and stopcock. The syringe is used to prime the device with saline and the stopcock is used to hold the saline in place when the syringe is removed. The stopcock may be used to close the fluid path if so desired. The retention guard 113 is machined with grooves on one side to allow saline to flow into the chamber 119 past the gap 111 and into the needle bore over the lead. Priming may be performed before the needle is inserted subcutaneously. The needle 101 is connected to the lead deployment device via a male luer fitting 120.

Figure 2.0 shows a lead 200 that may be deployed with a lead deployment device, such as with the lead deployment device 100 shown in Figure 1.0. The lead 200 includes electrodes numbered 0 to 3 (at 201, 202, 203 and 204). Each of the electrodes 0-3 is connected to a contact 206, 205, 204 and 203 (e.g., through internal conductors). The lead diameter 207 (e.g. , 087 mm) may be smaller than the bore of the lead deployment device and needle in which it is deployed, allowing it to fit and move freely. The lead 200 may also include marker bands to denote length at 208 and 209.

Figure 3.0 and 4.0 show needle and lead components 300 and 400, which may be implemented similarly and with the lead 200 of Figure 2. The lead components 300 and 400 may be positioned and routed through surrounding material/tissue with respect to a needle before it is deployed. Referring specifically to Figure 4.0, the needle tip 402 is shown positioned with lead 401 relative to the needle tip 402, which is part of a needle component 403. The lead 401 may be fed into the lead deployment device with a Tuohy Borst Valve open.

As shown in Figure 3.0, once the lead hits the material (e.g., patient tissue) at the tip of the needle 304 it will not be possible to feed the flexible lead 301 any further. The lead is contained by the needle shaft 303 and hub 302 and tissue at the tip of the needle. The lead may be deployed by placing the lead under compression forces sufficient to overcome retraction forces exerted by flexing of the lead through the route 305.

Figure 5.0 shows a front view 500 and side view 501 of a clamp piston 500, as may be implemented in accordance with one or more embodiments (e.g., with clamp piston 104 of Figure 1). The clamp piston 500 has a bore hole 502 through its entire length to accommodate a lead and a slide rod. This bore is design may provide low friction with the lead when the piston clamp is sliding. The clamp piston also contains a clamp slot 503 at one end and a piston head 504 at the other end. The clamp slot 503 acts as two cantilevers which are of sufficient length to enable an operator to clamp the cantilevers on a lead and prevent it from moving during needle retraction. The piston head 504 is sufficiently long enough to prevent snagging when sliding within its bore. Materials and surface finishes must also be chosen to accommodate smooth sliding.

Figure 6.0 shows front 600 and side 601 views of a retention guard 602, as may be implemented in accordance with one or more embodiments (e.g., with retention guard 114 of Figure 1.0). The retention guard is circular with grooves cut 603, 604 into the rear surface, and outer edge 605 with a bore hole 606, in the center to allow saline to freely flow (e.g., from a luer fitting into a needle). The retention guard 602 may include a non-compressible material such as a polymer (e.g., polycarbonate) for the range of forces expected.

Figure 7.0 shows front 700 and side 701 views of a compression seal 702 with a chamfer 703 and bore hole 704. In certain implementations, the compression seal 702 provides a Tuohy Borst concentric compression seal. The compression seal may be made of a compressible material such as a polymer, silicone or polyurethane with a durometer sufficient to exert the required retention force on a lead as characterized herein while still being compressible.

Figure 8.0 shows a compression valve assembly 800 with a slide rod 801 fixed in place at 802. This fixation may, for example, be achieved by glue or a force fit. The slide rod 801 is used to allow a lead to slide through. The assembly 800 is shown without a piston clamp and spring, which could be added (e.g., as shown in Figure 1.0) before assembly. An end view shows an outer diameter 803 of the compression valve assembly 800, which may be implemented with a screw thread that facilitates compression of a compression seal, such as compression seal 702 of Figure 7.0, when rotated using finger grips 804. A spring and piston head housing 806 may be used encapsulate a spring with a piston clamp using a force fit or glue joint at 805. A gap 807 between the piston head housing 806 and the slide rod 801 may be set sufficiently wide to provide clearance for the piston clamp to slide over the slide rod, mitigating catching with the piston head housing.

As characterized herein, the lead deployment devices and related componentry may be implemented in a variety of manners. Figure 9.0 shows such a lead deployment device (e.g., using the apparatus shown in Figure 1) undergoing a sequence of events in step 1 (901), step 2 (910) and step 3 (920), in which a needle is inserted with a lead and subsequently retracted, leaving the lead in its place. Such an approach can be utilized for deploying a lead in material such as patient tissue or a vessel, represented by datum plane A-A, using a lead deployment piston and clamp mechanism.

By way of example, deployment in a human patient’s tissue is hereinafter characterized. However such an approach can be utilized for deployment in any material, a vessel or other substance. Referring to Step 1, the needle and lead therein are inserted into tissue, with a portion extending beyond the datum A-A (and buried within tissue). As shown in Step 2, a portion of the lead deployment device is retracted extracorporeally in relation to the datum plane A-A while piston plunger 903 remains static with respect to the datum plane A-A during needle retraction. During this sequence the compression seal is left open and exerts little or no force on the lead allowing movement of the lead within the clamp piston 903 and slide rod. The compression seal may be used during needle 923 insertion. The series of diagrams thus show the lead deployment device being retracted, leaving the lead in place and the piston clamp mechanism in action.

More specifically regarding Step 1/901 of Figure 9.0, needle 923 is connected to the lead deployment device male luer 902. In this figure the clamp piston 903 is fully extended via the expansion forces of the compression spring 904. In order to deploy the lead, at 905 the operator first clamps the lead in place with the rod clamp 906 with their finger and thumb tips, 907. In the diagram shown pressing on the cantilever slot, bends the cantilevers and prevents the lead from moving with respect to the clamp piston. The needle / lead deployment device is now retracted with the operators’ other hand by moving the Lead deployment housing in the direction shown by the arrow 908 closer to the clamp position. During this action the clamp fingers are held in a constant position with respect to the patient’s body datum A-A 923.

Referring to Step 2/910 of Figure 9.0, the position of the piston head 911 and compression spring 912 is shown at the end of a needle/lead deployment device retraction stroke. The spring is compressed at this point. Holding the lead deployment device in position, keeping it static with respect to the datum A- A, the clamp 913 is released. The differences in diameters between the lead and bore hole of the clamp piston and slide rod may be chosen such that they exert little to no substantial force on the lead. This may be facilitated using lead in chamfers on all lead entrance bores, to mitigate snagging of the lead during clamp piston movement.

Referring to Step 3/920 of Figure 9.0, the compression spring decompresses at 921, moving the piston clamp in the direction of the arrow 924. After the operator unclamps the lead by unclamping their finger and thumb 922, the clamp piston will move forward 924 and reposition itself at its distended position.

Steps 1 to 3 may be cyclically repeated until the needle exits the surface of skin datum A-A 923, at which point the operator may place their index surgically gloved finger on the lead as its exits the skin to hold in place as the needle and lead deployment device are slid over the remaining length of the lead not deployed in the patient.

The lead deployment device can also be implemented without the use of the compression spring, such as by manually pulling the clamp piston forward after each retraction cycle. Step 3/920 shows the lead deployment piston clamp distension cycle which could be performed manually.

Figure 10.0 shows a lead deployment device 1000 similar to that shown in Figure 1.0 without the use of compression valve and the addition of a modified one-way valve 1021 to prevent saline leakage after priming. A cross-section is shown along the centerline of one general exemplary embodiment of the lead deployment device 1000 attached to a Tuohy tipped needle 1001 with a lead 1002 running through the center of the lead deployment device. For the purposes of this description, the needle is shown to have been inserted subcutaneously 1003 to a desired depth in a patient and the lead is ready to be deployed. The compression seal and retention guard shown in Figure 1.0 has been excluded in this embodiment simplifying the assembly.

The lead deployment device 1000 includes a clamp piston 1004 with the clamp 1005 at one end and the piston head 1006 at the other end. The clamp includes a slot in the clamp plunger resulting in two cantilevers which may be depressed by an operators’ index finger and thumb to clamp the lead in place. The clamp plunger uses spring force via the compression spring 1007 to ensure the clamp piston is fully extended when not under external forces. The clamp piston is capable of sliding over the slide rod 1008 which is fixed in place by a lead deployment housing body 1012 at point 1010. The plunger rod is contained within a cylinder bore 1009 containing the compression spring and the piston head 1006 of the clamp piston 1004. The cylinder bore 1009 may be assembled using adhesive, screw thread or interference fit. The clamp piston contains a slot at the external end 1005 which allows the user to compress the end of the clamp rod with their fingers such that the clamp piston forces the lead 1002 to move with the motion of the clamp piston. The piston rod may be made from an injection molded polymer or metal. The operational relationship between the clamp piston and the slide rod facilitates sliding of the lead within the housing body 1012 relative to the slot 1005 when it is clamped.

Saline may be infused into the lead deployment device via the luer 1018 to prevent air from being infused subcutaneously. This may be achieved using a syringe filled with saline. The syringe may be used to prime the device with saline and a stopcock may also be used to hold the saline in place when the syringe is removed. The stopcock may be used to close the fluid path if so desired. Priming can performed before the needle is inserted subcutaneously, the device is assembled as shown in Figure 10.0 with the addition of a syringe filled with saline and a stopcock and flushed with saline. The needle 1001 is connected to the lead deployment device 1012 via a male luer fitting 1020. The saline path for the flow of liquid during priming is shown by the dotted line 1019. Saline flows through the luer into the lead deployment housing body through a duckbill valve 1011 and into the needle hub and out into the needle lumen 1021. The duckbill valve may be made from a low durometer polymer such as silicone or polyurethane which allows the lead to pass through it while preventing saline from backflowing through the needle, luer 1018, slide rod 1008 and clamp piston. A blown-up cross-section of the duckbill valve is shown in 1021. The mechanism of action is the same as that outlined in Figure 9.0 consisting of a three-step process.

The duckbill valve 1011 is shown in a magnified view 1022 with a cross-section of the duckbill valve and piston slide 1008, having lead 1002 exiting through the duckbill section 1023. The duckbill is attached to the piston slide via a compression fit or adhesive.

Figure 11.0 shows a more detailed view of a duckbill valve 1111 with elevation 1101 and end 1102 views. The elevation 1101 is shown in cross-section B-B 1103 displaying how the duckbill valve 1111 necks down at 1104 to a diameter 1105 smaller than the diameter of a lead to be passed therein, to cause an interference fit as the lead is pushed through it and prevent saline leakage. The material may be chosen such that it is compliant and easily deforms under low force. Based upon the above discussion and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made to the present disclosure without strictly following the exemplary embodiments and applications illustrated and described herein. Such modifications and changes may include, for example, incorporating one or more aspects described in the above references and/or applying one or more embodiments thereto, or combining embodiments. Other changes may include using subcomponents having energy that is more associated with noise than with a desired signal, such as for applications in which a lower quality or resolution may be in order. These and other modifications do not depart from the true spirit and scope of the present disclosure, including that set forth in the following claims.

Claims

What is Claimed is:

1. An apparatus comprising:

a needle component having a housing and a needle tip, the needle component having an opening therein extending through the housing and tip and being configured to pass a lead therethrough; and

a clamp piston assembly coupled to the needle component and having an opening therein configured to pass the lead therethrough, the clamp piston assembly being configured and arranged with the needle component to move relative to one another while the lead passes therethrough, and to fix the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston.

2. The apparatus of claim 1, wherein

the needle component is configured and arranged for insertion to a depth within a material; and

the clamp piston assembly is configured and arranged with the needle component to clamp the lead in place with the needle tip extended to the depth within the material, and to slide linearly relative to the needle component as the needle component is retracted from the material while maintaining a tip of the lead is fixed in place at the depth within the material.

3. The apparatus of claim 1, wherein the needle component is configured and arranged to puncture tissue and to extend the needle tip to a depth within the tissue with a tip of the lead extending into the needle tip.

4. The apparatus of claim 1, wherein

the needle component is configured and arranged to puncture tissue and to extend to a depth within the tissue with the lead extending into the needle tip; and

the clamp piston assembly is configured and arranged with the needle component to clamp the lead in place with the needle tip extended to the depth within the tissue, and to slide relative to the needle component as the needle component is retracted from the tissue while maintaining a tip of the lead is fixed in place within the tissue.

5. The apparatus of claim 1, further including a spring component configured and arranged to: apply spring force to maintain the clamp piston assembly in a fixed relative position relative to the needle component;

in response to an external force that causes relative movement between the clamp piston assembly and the needle component that applies a force to the spring, facilitate movement of the clamp piston assembly and the needle component toward one another; and in response to the external force being released, cause the clamp piston assembly and needle component to move relatively away from one another toward the fixed relative position.

6. The apparatus of claim 1, further including the lead, the lead including a flexible conductor, wherein the needle component and clamp piston assembly are configured and arranged to maintain a portion of the flexible conductor extending within the needle component and clamp piston assembly in a linear arrangement.

7. The apparatus of claim 1, further including the lead.

8. The apparatus of claim 1, wherein the clamp piston assembly includes:

a cylindrical shell configured and arranged to pass the lead through an inner sidewall of the cylindrical shell; and

at a portion of the cylindrical shell, a lead clamp component configured and arranged to deflect and clamp the lead in response to an applied force to an outer sidewall of the cylindrical shell.

9. The apparatus of claim 8, wherein the lead clamp component includes a portion of the sidewall having an opening therein and a cantilever-type portion of the cylindrical shell adjacent the opening and that is configured and arranged to deflect and clamp the lead.

10. The apparatus of claim 1, wherein the needle component has a housing configured to accept the clamp piston assembly therein, the clamp piston assembly having a piston head that is configured with the housing to slide linearly within the housing with an outer surface of the piston head facing an inner surface of the housing, the respective surfaces being configured with one another to maintain alignment of the housing and the clamp piston assembly.

11. A method comprising:

passing a lead through a needle component and a clamp piston assembly, wherein: the needle component has a housing and a needle tip, and an opening therein extending through the housing and tip and being configured to pass the lead, and

the clamp piston assembly is coupled to the needle component and has an opening therein configured to pass the lead therethrough; and

fixing the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead, by clamping the lead to the clamp piston.

12. The method of claim 11 ,

further including inserting the needle component with the needle tip extending to a depth within a material, and positioning the lead component within the needle component and extending to the needle tip, and

wherein fixing the lead in place relative to the clamp piston assembly while the needle component moves includes clamping the lead to the clamp piston and holding the clamp piston in place relative to the material while withdrawing the needle component from the material by moving the needle component toward the clamp piston assembly as it is being retracted over the lead in the material.

13. The method of claim 12, wherein the material is tissue, further including, after the needle component has been withdrawn from the tissue, sliding the needle component and the clamp piston assembly off the lead while the lead remains in place within the tissue and at the depth to which the needle component was extended.

14. The method of claim 11, further including:

applying a spring force to maintain the clamp piston assembly in a fixed relative position relative to the needle component;

in response to an external force that causes relative movement between the clamp piston assembly and the needle component that applies a force to the spring, facilitating movement of the clamp piston assembly and the needle component toward one another; and in response to the external force being released, using the spring force to move the clamp piston assembly and needle component relatively away from one another toward the fixed relative position.

15. The method of claim 11, wherein passing the lead through the needle component and clamp piston assembly includes passing a tip of the lead into the needle component and to the needle tip, after the needle component has been inserted to a depth into a material.

16. The method of claim 11, clamping the lead in place includes applying pressure to a portion of the clamp piston assembly and therein causing the portion of the clamp piston assembly to deflect and clamp the lead relative to the clamp piston assembly.

17. The method of claim 11, wherein fixing the lead in place relative to the clamp piston assembly while the needle component moves relative to the clamp piston assembly and slides along the lead includes sliding a piston head of the clamp piston assembly within a housing of the needle component, the housing having an inner surface configured to accept the clamp piston assembly therein with an outer surface of the piston head interfacing therewith to maintain alignment of the housing and the clamp piston assembly.