Distal-lateral surgical tunneler

Abstract

Disclosed are a surgical tunneler, kits comprising the surgical tunneler, and methods of use thereof, for implanting access lines. The surgical tunneler includes an actuator configured to facilitate selective shifting between a distal tunneling configuration, wherein the distal body portion is fully covered with a cover, and a lateral tunneling configuration, wherein the distal body portion is at least partially uncovered. The surgical tunneler has a functional length configured to facilitate lateral tunneling under normal manual force when applied to the surgical tunneler proximally to the proximal body portion in the lateral tunneling configuration.

Description

Distal-Lateral Surgical TunnelerFIELD OF THE INVENTION

[0001] The present disclosure relates to vascular access lines and apparatus and methods for implanting vascular access lines, and more particularly, but not exclusively, to kits, devices and methods for implanting access lines through surgical tunnels.BACKGROUND OF THE INVENTION

[0002] Vascular access complications are common, with thrombosis and infection being the two major ones. Thrombosis commonly follows clot formation around the implanted catheter, which often occludes the blood vessel, propagates centrally and causes pain and swelling due to inadequate venous drainage. Infections in vascular access are associated with mortality and morbidity in hospitals worldwide. Catheter related bloodstream infection (CRBSI) can be caused by bacteria propagating on the catheter and dislodging into the bloodstream causing disseminated infection or even sepsis.

[0003] One of the major causes of clotting with catheters is reduced blood flow in the vessel following catheter implantation, whereas the smaller the vessel, the slower the flow around the catheter relative to normal flow rates prior to catheter implantation. The relation between the diameter of the vessel and the size of the catheter is a critical factor to consider for reducing the risk of clotting.

[0004] One of the common mechanisms of infection is passage of bacteria from the skin alongside the catheter from the skin entry site to the blood vessel. The greater the distance between the catheter entry site into the body and the blood vessel, the smaller the risk of infection is. For that reason, tunneled lines are known to reduce the risk of infections. Yet most lines, especially peripherally inserted central catheters (PICC) are inserted non tunneled. The reason is that a tunneled procedure is more complex to perform and involves two skin incisions, which increases risk for bleeding and infection and necessitates an operating room or an angiography suite.

[0005] Peripherally inserted central catheter (PICC) is a type of central venous catheter used for long-term intravenous access to the large central veins near the heart for antibiotics, chemotherapy, nutrition or medications, and for drawing blood samples. PICC failure can occurdue to infections, mechanical or vascular complications including damage to veins, deep venous thrombosis (DVT), occlusion, catheter-associated blood stream infection (CABSI).BRIEF DESCRIPTION OF THE FIGURES

[0006] FIGs. 1A - IN schematically illustrate exemplary scenarios representing steps in an exemplary method for implanting an access line in a body of a subject, according to some embodiments;

[0007] FIG. 2 illustrates an exemplary scenario where lateral tunneling is desirable;

[0008] FIG. 3 illustrates an exemplary surgical tunneler configured for distally directed tunneling;

[0009] FIG. 4 illustrates the surgical tunneler of FIG. 3 configured for laterally directed tunneling;

[0010] FIGs. 5A and 5B illustrate the surgical tunneler of FIGs. 3 and 4 in the distal and lateral tunneling configurations;

[0011] FIG. 6 illustrates the functional length of the surgical tunneler of FIGs. 3 and 4 in the lateral tunneling configuration;

[0012] FIG. 7 is a close-up perspective view of the surgical tunneler of FIG. 6;

[0013] FIG. 8 is a side view of the surgical tunneler of FIG. 6;

[0014] FIGs. 9A and 9B illustrate lateral surface areas of a surgical tunneler in the distal tunneling configuration and the lateral tunneling configuration respectively;

[0015] FIGs. 10A through 10H illustrate methods of using the surgical tunneler of FIG. 6.DETAILED DESCRIPTION

[0016] FIGs. 1A - IN schematically illustrate exemplary scenarios representing steps in an exemplary method for implanting an access line in a body BD of a subject SB. FIG. 1A illustrates a cross-sectional view of a portion of body BD showing a skin outer surface OS of body BD, underlying subcutaneous tissues ST, and shortly beneath it a bodily lumen in a form of a blood vessel BV. At a preliminary stage, the medical practitioner can determine or choose one or more of a first location IL, a preliminary insertion route PR, a second location 2L and a final insertion route FR. In some embodiments, final insertion route FR is substantially greater in length and inclined more gradually (i.e., less steep) relatively to skin surface, than preliminary insertion route PR, optionally particularly across subcutaneous tissues ST, as shown. FIG. IB illustrates an exemplary access needle 10 after it has penetrated through first location IL, across skin tissues,and into blood vessel BV with distal tip thereof, thereby forming preliminary insertion route PR for guidewire insertion. As shown in FIG. 1C, a guidewire 11 is advanced distally through access needle 10 until its distal end is in a chosen position inside blood vessel BV or in an organ cavity (e.g., a heart chamber) opened to blood vessel BV, and a proximal end 12 thereof is outside body BD. After a chosen positioning of guidewire 11 is met, access needle 10 is removed, leaving guidewire 11 extending along the preliminary insertion route PR (FIG. ID).

[0017] For forming final insertion route FR, an incision is made on skin outer surface OS at (over or across, for example) second location 2L and a surgical tunneller 17, which may also function as a guidewire manipulator as described below, is advanced therethrough towards a target portion 14 of guidewire 11 inside body BD, as shown in FIG. IE. Target location 14 is optionally located between the cutis (skin dermis and epidermis) and subcutis (i.e., subcutaneous tissue ST) of body BD, or within the subcutis, or distally adjacent to the subcutis. Surgical tunneler 17 includes a distal tip configured to dissect between tissue layers and is forcefully pushed through the subcutaneous tissues ST underlying skin outer surface OS thereby forming a surgical tunnel TN by advancing, from second location 2L to a target location in body BD in proximity to target portion 14 of guidewire 11.

[0018] When configured as a guidewire manipulator, surgical tunneler 17 is configured to facilitate selective hanging, hooking, fastening and / or locking to guidewire 11, such as at target portion 14 thereof, as shown in FIG. IE. Furthermore, once connected or hooked to guidewire 11, this embodiment of the surgical tunneler 17 can be selectively applied to manipulate a portion of guidewire 11 to fixedly (plastically) deform it. As shown in FIG. IF, guidewire 11 can be fixedly deformed by surgical tunneler 17 to form a local deviated portion 15 at or adjacent to target portion 14, which has reduced resistance to bending or folding relative to portions of the guidewire adjacent thereto, so that the next steps which involves folding to loop and pulling the loop can be facilitated or at least eased substantially. In some embodiments, local fixed deformation of a portion of guidewire 11 may be applied such as if the guidewire includes a metal core and / or if it is assessed or determined that surrounding tissues could be harmed when the guidewire is pulled laterally from within the body.

[0019] Following forming of deviated portion 15, guidewire 11 is pulled by surgical tunneler 17 at target portion 14, deviated portion 15, or in between them, thereby folding target portion 14 into a loop 16 (FIG. 1G). Guidewire 11 is further pulled by surgical tunneler 17 which is withdrawn in surgical tunnel TN towards second location 2L and gradually pulls and enlarges loop 16 (FIG.1H) until it is completely withdrawn and removed from body BD with loop 16 located in proximity to second location 2L and optionally emerges proximally therethrough (FIG. II). Guidewire 11 can then be unrolled and / or straighten, and loop 16 can be opened, such as by pulling guidewire's proximal part while leaving its distal part in place, until it follows the final insertion route FR, as shown in FIG. 1J, with its proximal end 12 extending outside the body BD via second location 2L and its distal end positioned in the chosen bodily lumen (e.g., in blood vessel BV or in an organ cavity opened thereto). In some embodiments, guidewire 11 is pulled by surgical tuneller 17 from a specific target portion of guidewire 11. In some such embodiments, surgical tunneler 17 is fastened onto the target portion of guidewire 11 throughout most or all pulling or withdrawal of guidewire 11 through surgical tunnel TN towards second location 2L. In some other embodiments, surgical tunneler 17 is not fastened to, or is sequentially fastened to and released from, guidewire 11, so that different portions of guidewire 11 are pulled by surgical tunneller 17 when guidewire 11 is withdrawn through surgical tunnel TN towards second location 2L.

[0020] The now (fully or partially) straightened or unrolled guidewire 11 extending along the final insertion route FR can be used for delivering a catheter introducer 18. Introducer 18 shown in FIG. IK includes a lumen with which it can be placed over and advanced over guidewire 11 until fully extending along final insertion route across the incision at second location 2L and reaching into the bodily lumen (e.g., blood vessel BV) with distal end thereof. Once introducer 18 is properly positioned, guidewire 11 can be pulled and removed from body BD through the introducer (FIG. IL). Introducer 18 may include a dilator extending therethrough, so removing of guidewire 11 may follow or include removing of dilator from introducer 18. Once introducer 18 is patent, an access line or catheter 19 can be advanced through introducer 18 along final insertion route FR and in the blood vessel BV (FIG. IM), and then the introducer 18 can be removed leaving access line or catheter 19 implanted in body BD (FIG. IN). Optionally, introducer 18 is splitable along weakened seams provided therealong, so its removal from body BD involves its splitting along the weakened seams.

[0021] FIG. 2 illustrates a situation that can occur when creating the tunnel TN during the abovedescribed procedure. In some cases, the trajectory of the tunnel TN formed by the surgical tunneler 17 may not be in an ideal direction with respect to the trajectory of the previously installed guidewire 11 for a guidewire manipulator, or a guidewire manipulating portion of surgical tunneler 17, to easily capture the guidewire 11 at target location 14 and subsequently manipulate the guidewire 11 as desired. In some cases, as illustrated in FIG. 2, it may be desirableto tunnel in a lateral direction as indicated by arrow 15 at the distal portion of the tunnel TN to successfully engage the guidewire 11 for manipulation. Although the arrow 15 is shown extending upward in FIG. 2, it will be appreciated that the desired direction of lateral tunnelling may be directed partially or wholly into or out of the page of the view shown in FIG. 2 depending on the relative locations of the target portion 14 of the guidewire 11 and the tunnel TN. The present disclosure is directed to surgical tunnelers and associated methods that facilitate the ability to tunnel both distally and laterally.

[0022] In this context, the function of tissue tunneling is to be distinguished from the function of tissue cutting. Tunneling involves separation of tissue layers to form a route through tissue and is performed with a tool having a tip blunter than a bladed instrument such as a scalpel which is intended to cut through a tissue layer. FIG. 2 illustrates a specific situation where it may be desired to extend or expand a tunnel in a direction lateral to an existing distally extending tunnel path rather than make a cut into or through the tissue on the side of a distally extending tunnel path. Although the example of FIG. 2 and other parts of this disclosure are directed to surgical tunnelers that include a guidewire capturing and / or guidewire manipulating functionality, it will be appreciated that lateral tunneling as described herein may be desirable in a wide variety of circumstances. The inventions described herein are applicable to any surgical tunneler that may or may not have functionality for capturing or manipulating target items or tissues in addition to tunneling functionality.

[0023] FIG. 3 illustrates a surgical tunneler 17 configured for distal tunneling. As noted above, guidewire manipulator 17 includes a distal tip 22 which may have a convex shape configured to dissect between tissue layers and may be forcefully pushed through the subcutaneous tissues ST underlying skin outer surface OS thereby forming a surgical tunnel TN by advancing the tip 22 in a substantially straight line in a distal direction shown by arrow 21 in FIG. 3. The surgical tunneler 17 may include a cover 26 that extends to or substantially to the proximal portion of the distal tip 22. The surgical tunneler 17 may also include an actuator 32 that can be used by the surgeon to manually advance and retract the cover 26 to transition the surgical tunneler 17 from being configured for distal tunnelling to lateral tunnelling. In FIG. 3, the actuator 32 is shown in the distal position corresponding to having the cover 26 advanced to the proximal portion of the distal tip 22. During distal tunneling, the cross section of the created tunnel may closely correspond to the outer diameter of the tunneler, specifically, in some embodiments, the outer diameter of the cover 26.

[0024] FIG. 4 illustrates the surgical tunneler 17 of FIG. 3 configured for lateral tunnelling. In the configuration of FIG. 4, the actuator 32 is in the proximal position, thereby retracting the cover 26, and exposing a distal portion of the surgical tunneler 17 that may be used for lateral tunnelling. In this configuration, a lateral portion of a distal portion of the surgical tunneler maybe configured to facilitate lateral tunneling. To perform the lateral tunneling, the proximal handle of the surgical tunneler can be moved manually with normal forces as indicated by arrow 23 in FIG. 4. This manual manipulation of the proximal handle may form a pocket 36 emerging laterally from distally extending tunnel (e.g. a preliminary surgical tunnel) made with the surgical tunneler in the distal tunneling configuration shown in FIG. 3. In the embodiment of FIG. 4 and the following figures, the distal portion of the surgical tunneler 17 is also configured for guidewire manipulation. However, the distal portion of the surgical tunneler 17 may be configured for other functions or the device may be dedicated simply to tunneling for the introduction of other instruments or implanted devices.

[0025] FIG. 5A shows a perspective view of the surgical tunneler 17 in the distal tunneling configuration. FIG. 5B shows a perspective view of the surgical tunneler in the lateral tunneling configuration of FIG. 4. In both cases, the device has a functional length 40 spanning both a distal portion 46 and a proximal portion 42 of the device. The functional length 40 of the device is the portion of the device configured to reside inside the tunnel in the tissue formed by the device. In FIG. 5A, the distal portion 44 and proximal portion 42 are inside cover 26 in the distal tunneling configuration. As shown in FIG. 5B, in the lateral tunneling configuration a distal body portion of the surgical tunneler suitable for lateral tunneling is at least partially exposed by retracting the cover 26.

[0026] Referring now to FIGs. 6, 7, and 8, the functional length 40 of the surgical tunneler 17 may comprise a distal portion 44 and a proximal portion 42. The proximal portion 42 may comprise a proximal body portion 1 having a first characteristic dimension (e.g. mean width in longitudinal cross section). The distal portion 44 may comprise a distal body portion 46 having a second characteristic dimension (e.g. mean width in longitudinal cross section) and a tip 22 having a third characteristic dimension (e.g. mean width in longitudinal cross section). In some advantageous embodiments, the third characteristic dimension of the tip 22 is equal to or greater than the first characteristic dimension of the proximal body portion 27 and is greater than the second characteristic dimension of the distal body portion 46. In some advantageous embodiments, the second characteristic dimension of the distal body portion 46 is less than the first characteristicdimension of the proximal body portion 27. As noted above, a retractable cover 26 may be configured to slide back and forth over the proximal body portion 1 and the distal body portion 46 under control of the surgeon. The total longitudinal length of the distal portion 44 may be at least 5% of the functional length 40, at least 10% of the functional length 40, and in some embodiments be at least 25% of the functional length 40. The longitudinal length of the tip 22 may be less than 50% of the distal portion 44, and may be less than 20% of the distal portion 44.

[0027] The distal body portion 46 may be configured to facilitate lateral tunneling by the provision of a lateral functional portion 49 which may be configured as a tissue tunneling / dissecting edge facing laterally away from the longitudinal axis of the surgical tunneler 17 in the direction of arrow 48b. This lateral functional portion 49 may be significantly thinner than the lateral side of the cover 26 that faces laterally in the direction of arrow 48a. The thickness of the lateral functional portion 49 of the distal body portion may be 25% or less than the maximum thickness of the proximal body portion 27. The lateral functional portion 49 may extend along more than 50%, more than 75%, or more than 90% of the length of the distal body portion 46. The lateral functional portion 49 should extend longitudinally for a length sufficient generate tunneling pressure at the tissue tunneling / dissecting edge to execute lateral tunneling under normal manual force when applied to the surgical tunneler proximally to the proximal body portion 42, e.g. at the handle of the tunneler 17 shown in FIG. 4.

[0028] The surgical tunneler embodiment of FIGs. 6, 7, and 8 is further configured as a guidewire manipulator. For this functionality, the distal body portion 46 is provided with a slot 52 formed therein and a passage forming an opening in the lateral functional portion 49 into the slot configured to allow the passing of a width of a guidewire from outside the surgical tunneler into the slot 52. The passage 54 may be angled relative to a longitudinal axis of the surgical tunneler and may slope toward the tunneler tip at a radially outward edge thereof and toward the proximal body portion 27 at a radially inward edge thereof.

[0029] For a surgical tunneler configured with a slot 52 for guidewire or other target item capture, the distal body portion 46 may be divided into a first portion 56 corresponding to the longitudinal extent of the slot 52 and a second portion 58 corresponding to the portion from the bottom of the slot 52 to the distal end of the proximal body portion 27. For lateral tunneling functionality, it is advantageous if the second portion 58 is at least as long as the first portion 56. In some embodiments, the second portion 58 is at least twice as long as the first portion 56. In some embodiments, the second portion 58 is at least three times as long as the first portion 56.In these embodiments, target item or tissue capture and / or manipulation can be successfully combined with lateral tunneling functionality.

[0030] FIGs. 9A and 9B further illustrate the difference between the lateral facing surface of the surgical tunneler 17 in the region of the distal body portion 46 between the distal tunneling configuration and the lateral tunneling configuration. For this purpose, the "lateral facing surface" will be defined as the surface facing within plus or minus 45 degrees of the lateral direction defined by arrows 48a and 48b of FIG. 6. This is illustrated in FIGs. 9A and 9B by the thick portions of the axial cross sections provided in these Figures. In the distal tunneling configuration illustrated in FIG. 9A, which is when the distal body portion 46 is covered by cover 26, the lateral facing surface has a first height or width 60. In the lateral tunneling configuration, when the cover 26 is retracted and the lateral functional portion 49 of the distal body portion 46 is exposed, the lateral facing surface has a second height or width 62. In some embodiments, the second height 62 is 25% or less of the first height 60. As noted above, this is configured to form a tissue tunneling edge but preferably not a bladed cutting edge along at least most of the distal body portion 46. To form a tunneling rather than a cutting edge, the second height 62 may be at least 1% of the first height 60. The total lateral surface area in the distal body portion 46 will be the bolded arc length in FIG. 9B times the length of the exposed distal body portion 46. In advantageous embodiments, the second height 62 and the total lateral facing surface area in the lateral tunneling configuration of FIG. 9B is 25% or less of the first height 60 and total lateral surface area in the distal tunneling configuration of FIG. 9A. It should be noted that the axial cross sections of FIGs. 9A and 9B are conceptual only, and the actual cross section contours may be different than what is shown. It will be appreciated that the illustration of FIG. 9B does not represent the axial cross section of the distal body portion 46 of FIGs. 6, 7, and 8 and is intended for explanatory purposes only, generally illustrating the thinner edge of lateral functional portion 49 with respect to the side of the cover 26. Furthermore, the axial cross section of the distal body potion 46 may vary along its length. In some embodiments, a portion of the lateral functional portion 49 may be formed as a bladed cutting edge, but such a portion, if present at all, is less than 50%, preferably less than 10% of the longitudinal extent of the distal body portion 46. For embodiments such as the one shown in FIGs. 6, 7, and 8, such a bladed portion may be associated with an area around the slot 52 and passage 54.

[0031] FIGs. 10A through 10H illustrate steps in a method of using the surgical tunneler 17 of FIGs. 6, 7, and 8 for lateral tunneling and target object manipulation. FIG. 10A shows lateraltunneling in the direction of a target object, which may be a guidewire 11. In the embodiment illustrated in FIGs. 10A-10H, the guidewire 11 extends transversely to the lateral functional portion of the surgical tunneler. The lateral tunneling of FIG. 10A may expose or release the target object from the soft tissue layers near the distal portion of the preliminary surgical tunnel. FIGs.10B through 10E illustrate capturing the target object in the slot 52. FIG. 10F shows locking, grasping, or pressing a portion of the target object by pushing the cover 26 against the tip 22 with the target object located therebetween. This may be repeated until affecting a plastic, residual, or permanent deformation of the target object is accomplished. FIGs. 10G and 10H illustrate pulling the target object back through the surgical tunnel.

[0032] Aspects of various device configurations and methods for guidewire manipulation that can be incorporated into and / or used with the surgical tunnelers described herein are set forth in more detail in PCT Publication WO 2023 / 133103, which is attached as Appendix A and forms part of this specification.

[0033] Each of the following terms written in singular grammatical form: 'a', 'an', and 'the', as used herein, means 'at least one', or 'one or more'. Use of the phrase 'one or more' herein does not alter this intended meaning of 'a', 'an', or 'the'. Accordingly, the terms 'a', 'an', and 'the', as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: 'a unit', 'a device', 'an assembly', 'a mechanism', 'a component', 'an element', and 'a step or procedure', as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.

[0034] Each of the following terms: 'includes', 'including', 'has', 'having', 'comprises', and 'comprising', and, their linguistic / grammatical variants, derivatives, or / and conjugates, as used herein, means 'including, but not limited to', and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase 'consisting essentially of'.

[0035] The term 'method', as used herein, refers to steps, procedures, manners, means, or / and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or / and techniques, either known to, or readily developed from known steps,procedures, manners, means, or / and techniques, by practitioners in the relevant field(s) of the disclosed invention.

[0036] Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible sub-ranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as '1', '1.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

[0037] Moreover, for stating or describing a numerical range, the phrase 'in a range of between about a first numerical value and about a second numerical value', is considered equivalent to, and meaning the same as, the phrase 'in a range of from about a first numerical value to about a second numerical value', and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase 'room temperature refers to a temperature in a range of between about 20 °C and about 25 °C, and is considered equivalent to, and meaning the same as, the phrase 'room temperature refers to a temperature in a range of from about 20 °C to about 25 °C.

[0038] The term 'about', as used herein, refers to ± 10 % of the stated numerical value.

[0039] It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.

[0040] Although the invention has been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or / and variations, thereof, will be apparent to those skilled in the art. Accordingly, it is intended that all such alternatives, modifications, or / and variations, fall within the spirit of, and are encompassed by, the broad scope of the appended claims.

[0041] All publications, patents, and or / and patent applications, cited or referred to in this disclosure are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent, or / and patent application, was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this specification shall not be construed or understood as an admission that such reference represents or corresponds to prior art of the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

Claims1. A surgical tunneler, comprising:an elongated tunneler body comprising a proximal body portion, a distal body portion and a tip emerging distally from the distal body portion;a cover sized to cover the proximal body portion and the distal body portion between a proximal end of the proximal body portion and a proximal end of the tip; andan actuator configured to facilitate selective axial shifting of the cover relative to the elongated tunneler body between a distal tunneling configuration, wherein the distal body portion is fully covered with the cover, and a lateral tunneling configuration, wherein the distal body portion is at least partially uncovered;wherein the elongated tunneler body is configured with a functional length spanning over the proximal body portion and the distal body portion, the functional length configured for penetrating a body of a subject and surgically forming a subcutaneous tunnel, wherein the elongated body along the functional length thereof is configured to facilitate lateral tunneling under normal manual force when applied to the surgical tunneler proximally to the proximal body portion in the lateral tunneling configuration.

2. The surgical tunneler according to claim 1, wherein a total length of the distal body portion is at least 25% of the functional length.

3. The surgical tunneler according to any preceding claim, wherein the distal body portion includes a lateral functional portion configured for facilitating the lateral tunneling, having a lateral facing surface with a width of 25% or less of a width of a lateral facing surface of the cover.

4. The surgical tunneler according to claim 3, wherein the lateral functional portion has a triangular or convex shaped cross section having a sharp or curved tip facing away from a longitudinal axis of the surgical tunneler.

5. The surgical tunneler according to any one of claims 3 or 4, wherein the lateral functional portion extends along most or all length of the distal body portion.

6. The surgical tunneler according to any one of claims 1 through 5, wherein a total lateral surface area of the surgical tunneler along the distal body portion when in the lateral tunneling configuration is less than 25% of the total lateral surface area of the surgical tunneler when in the distal tunneling configuration.

7. The surgical tunneler according to any one of claims 1 through 6, wherein the surgical tunneler comprises target item capturing and / or manipulation structures associated with the distal body portion.

8. The surgical tunneler according to any one of claims 1 through 7, wherein the distal body portion comprises a slot and a passage opened to the slot configured for allowing passing of a width of a guidewire from outside the surgical tunneler into the slot.

9. The surgical tunneler according to claim 8, wherein the passage is angled relative to a longitudinal axis of the surgical tunneler.

10. The surgical tunneler according to any one of claims 8 or 9, wherein the passage slopes towards the tunneler tip at a radially outward edge thereof and towards the proximal portion at a radially inward edge thereof.

11. The surgical tunneler according to any preceding claim, wherein a characteristic dimension of the tip is equal to or greater than a characteristic dimension of the proximal portion and greater than a characteristic dimension of the distal body portion.

12. A method for forming a surgical tunnel in a body of a subject, the method comprising:providing a surgical tunneler according to any one of claims 1 through 11 in the distal tunneling configuration;forming a surgical opening in a skin portion of the body;pushing the surgical tunneler distally in the body via the surgical opening in a chosen orientation beneath the skin, such that the tunneler tip dissects and / or cuts between soft tissue layers, until gradually forming a preliminary surgical tunnel, wherein a cross-sectional dimension of the preliminary surgical tunnel closely corresponds to a maximal outer diameter of the surgical tunneler providing a close fit therebetween;shifting the surgical tunneler to the lateral tunneling configuration, such that the lateral functional portion is exposed to the soft tissue layers; andvia a proximal end of the surgical tunneler, forcing the lateral functional portion against the soft tissue layers, thereby pushing the soft tissue layers, or dissecting therebetween, laterally to the preliminary surgical tunnel.

13. The method according to claim 12, further comprising proceeding or repeating the forcing until forming a final surgical tunnel having a width or a thickness greater than the cross-sectional dimension of the preliminary surgical tunnel.

14. The method according to claim 13, wherein the final surgical tunnel is substantially a superposition of the preliminary surgical tunnel and a surgically formed pocket emerging laterally from the preliminary surgical tunnel.

15. The method according to any one of claims 12 through 14, further comprising:proceeding or repeating the forcing until exposing a target object from the soft tissue layers;capturing the target object with or within the distal portion.

16. The method according to claim 15, further comprising pulling the target object proximally with the surgical tunneler.

17. The method according to any one of claims 15 or 16, further comprising locking, grasping and / or pressing a portion of the target object by pushing the cover member against the tunneler tip.

18. The method according to claim 17, wherein the grasping and / or pressing is configured for, and / or is proceeded or repeated until, affecting a plastic, residual, or permanent deformation of the portion of the target object.

19. The method according to any one of claims 15 through 18, wherein the target object is a guidewire.

20. The method according to claim 19, wherein prior to the capturing the guidewire extends transversely to the functional lateral portion.

21. The method according to any one of claims 19 or 20, further comprising manipulating a portion of the guidewire.

22. The method according to claim 21, wherein the manipulating is configured for, and / or is proceeded or repeated until, affecting a plastic, residual, or permanent deformation of the portion of the guidewire.

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