US20080103456A1 - Infusion catheter - Google Patents

Abstract

A catheter for use with a medical infusion or other fluid system. The catheter may include a flexible elongate tubular core that is resistant to radial collapse. The catheter may further include a flexible, e.g., elastomeric, jacket that surrounds at least a portion of the tubular core. The jacket may have a radial compliance that is greater than that of the tubular core. The jacket may further define an outer diameter that is about 4 to about 6 times greater than an outer diameter of the core.

Description

RELATED APPLICATIONS
• The present application is a continuation-in-part of U.S. patent application Ser. No. 11/589,694, filed Oct. 30, 2006, and is also a continuation-in-part of U.S. patent application Ser. No. 11/589,697, also filed Oct. 30, 2006, both of which are incorporated herein by reference in their respective entireties.
TECHNICAL FIELD
• The present invention relates generally to medical devices and, more particularly, to catheters, portal anchors, catheter connectors, and systems for delivering a therapeutic agent to a region of a body such as the brain.
BACKGROUND
• Medical procedures involving the delivery or removal of fluids from the body often utilize a catheter system for fluid transport. The catheter system may include a flexible tube or catheter that operatively enters the body, and an externally located fluid reservoir. One example of a removal catheter system is a urinary catheter for use with patients that may have difficulty urinating.
• Other catheter systems are capable of delivering a fluid, e.g., a therapeutic agent, to the body. For example, the use of intracerebroventricular or parenchymal catheters is known for infusing therapeutic agents to a specific location within the brain to treat a variety of disorders including, for example, chronic pain and movement disorders. In an illustrative example, an incision is made in a patient's scalp to expose the skull through which a burr hole may then be formed. The catheter may then be inserted through the burr hole and anchored in place, e.g., with a burr hole anchor. Surgeons may often use stereotactic apparatus/procedures to position implanted catheters and other brain instruments (e.g., electrical stimulation leads). For example, U.S. Pat. No. 4,350,159 to Gouda illustrates an exemplary stereotactic instrument used to position an electrode.
• As one can appreciate, once an inserted device such as a catheter is properly positioned, it is important that it be adequately immobilized to prevent movement from its intended location. Even minimal movement of the device tip may yield unsatisfactory therapeutic results. Accordingly, reliable methods and apparatus for anchoring and securing the device relative to the burr hole are needed. To secure the catheter relative to the burr hole, burr hole anchor devices, including devices similar to those described in U.S. Pat. No. 4,328,813 to Ray and U.S. Pat. No. 5,927,277 to Baudino et al., may be used.
• Many of these anchor devices are used primarily to secure a catheter or lead for long term implantation. Some therapies (e.g., acute gene therapy for the treatment of Parkinson's disease, chemotherapy), however, may be delivered during a more limited period of time, e.g., a few hours to a few days or less. In the case of the latter, it may be beneficial to completely remove the delivery catheter at therapy completion. Device (e.g., catheter) removal, though, generally requires a surgical procedure to: expose the burr hole and anchor; release the catheter from the anchor; remove the catheter; and close the incision. While effective, such a removal procedure may be undesirable for various reasons, including, for example, cost and potential patient apprehension associated with the surgical removal procedure.
• The portion of the catheter extending beyond the skull may be tunneled beneath the skin (e.g., to connect to an implanted reservoir or pump) or, alternatively, routed outside the body where it may connect, typically via a longer secondary tube, to an external source containing the therapeutic agent.
• While fully implanted systems may be beneficial for long term treatment of certain chronic ailments, external routing may be preferable for shorter term therapies (e.g., those lasting a few days or less). Current external routing configurations may, however, present issues not necessarily present with internal systems. For example, the externalized components may benefit from various attachment and strain relief techniques to minimize movement of the implanted catheter that might result from exposure to inadvertent, external forces. Moreover, in the event of a catheter break, the externalized catheter system may require component replacement and/or additional sterilization procedures in order to reduce potential contamination. While such attachment techniques and sterilization procedures are effective, it may be beneficial if the need for such additional measures could be reduced or eliminated.
• Short term therapies may further benefit from catheters that are of an advantageous size (e.g., diameter) for the particular therapy delivery profile. For example, many conventional catheters are of a diameter that is unnecessarily large for shorter term, low volume therapy delivery. However, conventional catheters having a small diameter may be subject to inadvertent occlusion as a result of anchoring or twisting of the catheter.
SUMMARY
• Catheters, anchors, connectors, and systems in accordance with embodiments of the present invention may overcome these and other issues. For instance, in one embodiment, an implantable catheter is provided for delivering a therapeutic agent to a body. The catheter includes an elongate tubular core having a distal end and a proximal end, wherein the core defines a lumen extending between the distal and proximal ends. The core includes a material selected from the group consisting of silica, quartz, and polyetheretherketone (PEEK). The catheter also includes an elastomeric jacket surrounding and secured to an outer surface of the tubular core, the elastomeric jacket having a radial compliance greater than a radial compliance of the tubular core. An outer diameter of the elastomeric jacket is about 4 or more times larger than an outer diameter of the tubular core.
• In another embodiment, an implantable catheter for delivering a therapeutic agent to a body is provided, wherein the catheter has an elongate tubular core including fused silica. The tubular core includes a distal end, a proximal end, and a tubular body forming a lumen spanning between the distal and proximal ends. An elastomeric jacket including polyurethane is also provided, the jacket surrounding and secured to an outer surface of the tubular core. An outer diameter of the elastomeric jacket is about 4 to about 6 times greater than an outer diameter of the tubular core.
• The above summary is not intended to describe each embodiment or every implementation of the present invention. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following Detailed Description of Exemplary Embodiments and claims in view of the accompanying figures of the drawing.
BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING
• The present invention will be further described with reference to the figures of the drawing, wherein:
• FIGS. 1A-1B illustrate an exemplary system, e.g., infusion system, including a connector (e.g., breakaway connector), infusion catheter, and portal anchor in accordance with one embodiment of the invention, wherein:FIG. 1A is a diagrammatic view of the system implanted in a human body; andFIG. 1B is a view of the system removed from the body;
• FIGS. 2A-2B illustrate enlarged perspective views of the exemplary connector ofFIGS. 1A-1B, wherein:FIG. 2A is an enlarged perspective view of the connector; andFIG. 2B is an exploded perspective view illustrating how a modified connector may be attached to a headgear apparatus;
• FIG. 3 is a section view of the connector ofFIG. 2A, taken through a plane containing a longitudinal axis of the connector, illustrating both a first coupler and a second coupler;
• FIG. 4 illustrates the section of the connector shown inFIG. 3 with the first coupler shown separated from the second coupler;
• FIGS. 5A-5B illustrate an exemplary retention device, e.g., a roller assembly, for use with the connector ofFIG. 2A, wherein:FIG. 5A is an enlarged perspective view of the roller assembly; andFIG. 5B is a section view taken alongline5B-5B ofFIG. 2A;
• FIG. 6 is an exploded perspective view of the first coupler of the connector ofFIG. 2A;
• FIGS. 7A-7C illustrate various aspects of the first coupler ofFIG. 2A, wherein:FIG. 7A is a section view of the first coupler in a partially assembled state, the view taken through a plane containing a longitudinal axis of the first coupler;FIG. 7B is a perspective view of a stop member of the first coupler; andFIG. 7C is a partial perspective section view of a portion of the first coupler;
• FIGS. 8A-8B illustrate a retention device in accordance with another embodiment of the invention, wherein:FIG. 8A is an exploded partial perspective view; andFIG. 8B is a perspective section view;
• FIGS. 9A-9B illustrate a catheter in accordance with one embodiment of the invention, whereinFIG. 9A illustrates a side elevation view; andFIG. 9B illustrates a section view taken alongline9B-9B ofFIG. 9A;
• FIGS. 10A-10E illustrate a catheter in accordance with another embodiment of the invention, whereinFIG. 10A illustrates a breakaway side elevation view;FIG. 10B illustrates an enlarged breakaway view of a portion of the catheter;FIG. 10C illustrates a section view taken alongline10C-10C ofFIG. 10A;FIG. 10D illustrates an enlarged section view of a distal end portion of the catheter; andFIG. 10E is a side elevation view;
• FIGS. 11A-11E illustrate a catheter in accordance with another embodiment of the invention, whereinFIG. 11A illustrates a breakaway side elevation view;FIG. 11B illustrates an enlarged breakaway view of a first portion of the catheter;FIG. 11C illustrates an enlarged breakaway view of a second portion of the catheter;FIG. 11D is a section view taken alongline11D-11D ofFIG. 11A; andFIG. 11E is section view taken alongline11E-11E ofFIG. 11B;
• FIG. 12 is a perspective view of the exemplary anchor assembly, e.g., burr hole anchor, ofFIGS. 1A-1B with a base of the anchor shown attached to the body, e.g., skull, and a retainer of the anchor shown before attachment to the base;
• FIG. 13 is a cross section of the anchor assembly ofFIGS. 1A-1B as it may be implanted within the body;
• FIG. 14 is an exploded perspective view of the anchor assembly ofFIGS. 1A-1B;
• FIG. 15 is a partial cut-away view of the anchor ofFIGS. 1A-1B, wherein the retainer is shown in a first or unlocked configuration corresponding to an arm of the retainer being in a first or unlocked position, and further wherein a latch of the retainer is shown in a first or unlatched position;
• FIG. 16 is a perspective view of the anchor assembly ofFIGS. 1A-1B with the retainer shown in a second or locked configuration corresponding to the arm being in a second or locked position, and the latch of the retainer shown in a second or latched position;
• FIG. 17 is a top plan view of the anchor assembly ofFIG. 15 with the arm shown in the unlocked position, but with the latch shown in the latched position;
• FIG. 18 is a top plan view of the anchor assembly ofFIG. 16 with the arm shown in the locked position and the latch shown in the latched position;
• FIGS. 19A-19B illustrate section views of the anchor assembly ofFIG. 17, wherein:FIG. 19A is a section view taken alongline19A-19A ofFIG. 17 but with the latch of the retainer shown in the unlatched position; andFIG. 19B is a section view similar to that ofFIG. 19A, but with the latch of the retainer shown in the latched position;
• FIG. 20 is a bottom plan view of the anchor assembly ofFIG. 17 with the latch shown in the latched position and the arm shown in the unlocked position;
• FIGS. 21A-21D illustrate an exemplary method for using the anchor assembly ofFIGS. 1A-1B, wherein:FIG. 21A illustrates attachment of the anchor base to the skull;FIG. 21B illustrates insertion of the anchor retainer into the anchor base;FIG. 21C illustrates external portions of the anchor assembly and catheter after an implantation incision is closed; andFIG. 21D illustrates unlocking and removal of the catheter at therapy completion;
• FIGS. 22A-22B illustrate an anchor assembly in accordance with an alternative embodiment of the invention, wherein:FIG. 22A is a perspective view of the anchor assembly during assembly of an anchor retainer with an anchor base; andFIG. 22B illustrates the anchor assembly after assembly and with the retainer shown in a first or unlocked configuration corresponding to an arm of the retainer being in a first or unlocked position;
• FIG. 23 is a perspective view of the anchor assembly ofFIGS. 22A-22B with the retainer shown in a second or locked configuration corresponding to the arm being in a second or locked position;
• FIGS. 24A-24B illustrate an optional cap for use with the anchor assembly ofFIGS. 22A-22B, wherein:FIG. 24A is a bottom perspective view prior to attachment of the cap; andFIG. 24B is a top perspective view after attachment of the cap; and
• FIGS. 25A-25D illustrate an anchor assembly in accordance with yet another embodiment of the invention, wherein:FIG. 25A is a perspective view of the anchor assembly during attachment of an anchor retainer with an anchor base;FIG. 25B illustrates immobilization of the catheter;FIG. 25C illustrates release of the catheter, e.g., at therapy completion; andFIG. 25D illustrates a bottom perspective view of the anchor retainer ofFIGS. 25A-25C.
• The figures are rendered primarily for clarity and, as a result, are not necessarily drawn to scale.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
• In the following detailed description of illustrative embodiments of the invention, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the invention.
• Embodiments of the present invention are directed generally to fluid coupling devices, fluid conduits, anchoring devices, and to systems and methods incorporating the same. For example, embodiments of the invention may include: medical connectors for coupling a first tube (e.g., catheter) to a second tube; corresponding tubes and catheters; and body portal anchors for securing therapy delivery devices (such as tubes/catheters) relative to a body portal. Other embodiments of the invention may be directed to implantable medical systems, e.g., infusion systems (incorporating one or more of these components), for infusing a therapeutic agent into a body.
• FIGS. 1A and 1B illustrate an exemplary implantable medical system (e.g., a brain infusion catheter system100) in accordance with one embodiment of the invention.FIG. 1A illustrates the system as it may be configured during use, e.g., implantation, whileFIG. 1B illustrates the system removed from the body.
• The exemplary infusion system may include a first medical tube, e.g.,brain catheter108, and a second medical tube, e.g.,secondary tube102. Thetube102 may have itsdistal end104 coupled to a reservoir (e.g.,infusion pump106, which may be identical or similar in construction to insulin pumps such as the Paradigm515 or715 pumps produced by Medtronic MiniMed of Northridge, Calif., USA) containing a volume of a therapeutic agent. Similarly, thebrain catheter108 may have itsdistal end110 implanted within the body101 (as used herein, the terms “distal” and “proximal” are taken from the reference of aconnector200 as shown inFIG. 1). In the illustrated example, thecatheter108 has itsdistal end110 implanted, via aburr hole112, at a predetermined location within abrain114 of the patient. Aburr hole anchor1200 may be used to secure thecatheter108 relative to theburr hole112. Theanchor1200 may form part of ananchor assembly1201 that may also include alock member1208 described in more detail elsewhere herein. Aproximal end116 of thecatheter108 may extend outside thebody101 and connect to a correspondingproximal end118 of thetube102, e.g., via theconnector200.
• While described herein in the context of apump106, this configuration is not limiting. For example, other embodiments may replace the pump with most any medicament delivery device, e.g., syringe, drip bag, etc., without departing from the scope of the invention.
• Thesystem100 may, in one embodiment, be configured to deliver a therapeutic agent containing a virally mediated gene therapy as an acute treatment for Parkinson's disease. The therapeutic agent is delivered, via thetube102 andcatheter108, from thepump106 to thebrain114. This application is not limiting, however, as the system may be configured to deliver most any therapeutic agent (e.g., chemotherapy) to most any area of the body without departing from the scope of the invention.
• It is noted that the terms “comprises” and variations thereof do not have a limiting meaning where these terms appear in the accompanying description and claims. Moreover, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably herein.
• Relative terms such as left, right, forward, rearward, top, bottom, side, upper, lower, horizontal, vertical, and the like may be used herein and, if so, are from the perspective observed in the particular figure. These terms are used only to simplify the description, however, and not to limit the scope of the invention in any way.
• With this general overview, the following description will address various embodiments of thesystem100 and its components, and methods for making and using the same. While these embodiments may be described with some degree of specificity, they are nonetheless intended to be exemplary. Those of skill in the art will recognize that other embodiments are possible without departing from the scope of the invention.
• It is further noted that the following description is organized by headings and subheadings for organizational purposes only. Accordingly, the particular headings/subheadings are not intended to limit in any way the embodiments described therein, i.e., alternative embodiments of a component presented under one heading or subheading of the specification may be found elsewhere (e.g., under another heading) in the specification. As a result, the specification is intended to be considered in its entirety.
Connectors
• One aspect of the present invention is directed generally to fluid coupling devices and, in particular, to medical connectors such asconnector200 shown inFIGS. 1A and 1B, systems, and to methods for coupling a first tube (e.g., catheter) to a second tube or other medical device. In the illustrated embodiment, the connector is shown as part of the catheter, e.g., infusion,system100 having the partially implantedcatheter108 and theexternal infusion pump106. However, this configuration is not limiting as embodiments of the connectors, connector systems, and other aspects of the present invention may find use in other catheter applications, as well as in other medical and non-medical fluid systems.
• Connectors in accordance with embodiments of the present invention may be configured to separate or de-couple once a threshold traction force is applied across the connector (e.g., applied to the twotubes102,108 joined by the connector). As a result, the connector provides a “breakaway” function in the event of exposure to inadvertent forces. Preferably, two couplers of the connector engage one another via a low friction (e.g., substantially functionless) retention device. In the embodiments described and illustrated herein, the connector may also maintain a closed fluid path, in the event of connector breakaway, to protect the implanted catheter from contamination.
• An enlarged view of theexemplary connector200 is illustrated inFIG. 2A. Theconnector200 may include a second connector portion orcoupler202 attached to thesecondary tube102 and a first connector portion orcoupler204 attached to thebrain catheter108 as further described below (see alsoFIG. 11B). In the illustrated embodiment, thefirst coupler204 may be supported by an optional headgear apparatus120 (seeFIG. 1A), which may hold theconnector200, e.g., via a connection with the first coupler, during implantation. While illustrated as supported by aheadgear apparatus120 inFIG. 1A, theconnector200 could alternatively be generally unsupported, e.g., supported only by the free proximal ends116 and118 of thecatheter108 andtube102, respectively, without departing from the scope of the invention.
• As further illustrated inFIG. 1A, thecatheter108 may be supported at the body by the body portal anchor, e.g.,burr hole anchor1200. Exemplary burr hole anchors are described in more detail below and in related U.S. patent application Ser. No. 11/589,697, filed on Oct. 30, 2006.
• FIG. 2B illustrates one exemplary embodiment for attaching theconnector200 to theheadgear apparatus120. The headgear apparatus may be formed from a series of adjustable, fabric (e.g., nylon webbing) or elastic bands (only twobands120a and120b are illustrated inFIG. 2B). The bands may surround the head of the patient, as shown inFIG. 1A, sufficiently to reduce or even prevent theheadgear apparatus120 from substantial movement relative to the patient's head. On one or more sides, theheadgear apparatus120 may have attached thereto (e.g., riveted) a circular snapfit receptacle122 that, in one embodiment, is similar or identical to the female portion of a conventional metallic garment snap button.
• Thefirst coupler204 of theconnector200 may optionally include an integrally formed (or otherwise attached) bracket that forms a receiving slot207 (shown only inFIG. 2B) along one side. The receivingslot207 may be configured to receive atab126 of aclip128. Once thetab126 is fully inserted into theslot207, theclip128 may be generally attached to theconnector200 until the components are intentionally disassembled. The clip may also include amale member130 that is receivable by the snap fit receptacle122 (themale member130 may be similar or identical in construction to a male portion of the conventional garment snap button). Once the clip is attached to thereceptacle122, the clip (and thus the connector200) may pivot generally about an axis of the receptacle, e.g., providing some degree of stress relief to thecatheter108.
• FIG. 3 is a cross sectional view of theconnector200 ofFIG. 2A (taken through a plane containing a longitudinal axis of the connector) with thecouplers202 and204 connected.FIG. 4, on the other hand, is a similar section view with the couplers detached. Each of thecouplers202 and204 is described separately below with reference to these figures.
• Thesecond coupler202 may form atubular body205 defining abore206. Thebody205 may be made from various materials including, for example, polyetheretherketone (PEEK), polycarbonate, and similar materials. Ahollow needle208 may be attached to thebody205 and extend into thebore206 as illustrated. Theneedle208 may define a lumen or passageway in fluid communication with thetube102. Theneedle208 may be affixed to thebody205 via any acceptable technique including, for example, by adhesive.
• Thebody205 also defines a smallersecondary bore210 configured to receive thetube102. Thetube102 may attach to the second coupler in a manner similar to theneedle208, e.g., with adhesive. When assembled as illustrated inFIGS. 3 and 4, fluid may travel from the source (e.g., pump106 ofFIGS. 1A-1B) through a lumen of thetube102 and through thehollow needle208.
• Theconnector200 may further include a retention device, e.g.,biased retention device300, which, in the illustrated embodiment, is attached to, or otherwise associated with, thesecond coupler202. Theretention device300, further illustrated inFIGS. 5A and 5B (some structure removed for clarity in these views), may include aroller assembly301 having anaxle302 and acylindrical roller304 rotatable about the axle. A tension member, e.g.,spring306, may also be included and attached to opposite first and second ends of theaxle302. Thespring306 may extend circumferentially about thetubular body205 of thesecond coupler202 as shown.
• The roller assembly, e.g., thecylindrical roller304, may, in a first configuration, be positioned offset from (and preferably transverse to), anaxis214 of the first and second couplers. Theaxle302 may be configured to move (e.g., translate) withinslots212 formed in thebody205 such that the axle androller304 are movable primarily in a radial direction308 (seeFIGS. 4,5A, and5B) from the axis214 (seeFIG. 4) of the couplers. Thespring306, which may be a conventional (e.g., stainless steel) extension spring, may provide a radially-biased force to theaxle302 that tends to pull the roller assembly301 (e.g., theaxle302 and roller304), towards theaxis214. The other components of the roller assembly, e.g., theroller304 and theaxle302 may also be made from stainless steel or other materials as described below.
• Theroller assembly301 may further include a washer orflange310. The flange310, which may be integrally formed with theaxle302, assists with guiding theroller assembly301 within theslots212 as shown inFIGS. 5A and 5B.
• As illustrated inFIG. 5B, theroller assembly301 of the retention device may also include a contact surface312 (e.g., the outer surface of the roller304). Thecontact surface312 may, in the illustrated embodiment, form asecant311 extending through thebore206 of thetubular body205 when the roller assembly is in the first configuration shown in solid lines inFIG. 5B (e.g., corresponding to agrooved surface226 of the first coupler204 (seeFIG. 4) being aligned with the roller304). As further described below, theroller assembly301, e.g., theroller304 andcontact surface312, may move to a second configuration (shown in broken lines inFIG. 5B), wherein thecontact surface312 is located at or outside of thebore206. Thus, as further described below, theroller assembly301 may be configured to selectively interlock thesecond coupler202 with thefirst coupler204; and release the first coupler from the second coupler when a predetermined traction force is applied between the first and second couplers.
• Thesecond coupler202 may further include anoptional sleeve216 that covers at least a portion of the outer surface of thebody205. Thesleeve216 may reduce the potential for patient/clinician contact with portions of theretention device300, and may further prevent foreign objects from interfering with its operation. Exemplary materials for the sleeve include polyurethane and polypropylene. Thesleeve216 may include a lip (e.g., a discontinuous lip as shown inFIGS. 3 and 4) or other locating feature that permits it to snap or bias into place relative to thebody205.
• Thefirst coupler204 is illustrated in detail inFIGS. 3,4,6, and7A-7C. The first coupler may, in the illustrated embodiment, be formed by anattachment member218 and ahousing220, both of which may be constructed from materials similar to thebody205 of thesecond coupler202.
• Theattachment member218 may include anengagement portion219 receivable within thebore206 of thesecond coupler202. Theattachment member218 may also include abody portion217 that is threadably engagable with thehousing220. In the illustrated embodiment, theattachment member218 is, when inserted into thebore206, coaxial with thesecond coupler202.
• Theengagement portion219 may include anouter surface222 having a generally cylindrical cross section. Theroller304 of theroller assembly301 may be configured to engage theouter surface222 of theengagement portion219 in rolling contact as the engagement portion moves, e.g., translates, within thebore206 of thesecond coupler202. Theouter surface222 may be formed by both anengagement surface224 defined by a first diameter, and the grooved surface226 (or “groove”) defined by a second diameter that is less than the first diameter (see, e.g.,FIG. 4). Thegrooved surface226 is positioned along theengagement surface224 so as to receive theroller assembly301 of the retention device (e.g., the roller304) when thefirst coupler204 is fully engaged with thesecond coupler202 as shown inFIG. 3. The phrases “fully engaged,” “fully connected,” “fully inserted,” and the like are used herein to indicate that the noted components are engaged to a point where further engagement is either not possible or not necessary to the proper functioning of the connector.
• Theouter surface222 may further include a rampedsurface228 extending between thegrooved surface226 to theengagement surface224. The rampedsurface228 may act as a camming surface to permit rolling contact of theroller304 back and forth between theengagement surface224 and thegrooved surface226.
• Theattachment member218 may form a tubular wall that defines apassageway221 extending through the attachment member. Thepassageway221 may surround or otherwise contain a needle-penetrable septum230 in the vicinity of theengagement portion219. Theseptum230 may be made of most any material that permits selective penetration by theneedle208 and self-sealing upon needle withdrawal. While other materials are possible, theseptum230 is, in one embodiment, made of silicone.
• Theseptum230 may be secured within thepassageway221 in most any fashion. For example, in the illustrated embodiment, thepassageway221 may form a step surface232 (e.g., proximate the engagement portion219) against which theseptum230 may be located. A retainingmember234 may then be secured (e.g., via adhesive or the like) within thepassageway221 to secure theseptum230 in place. The retainingmember234 may, in one embodiment, have a taperedinterior surface236 that assists in guiding theneedle208 into theseptum230 as thefirst coupler204 is connected to thesecond coupler202.
• Theattachment member218 may be attached to thehousing220 before use as further described below. While the particular attachment technique may vary without departing from the scope of the invention, thebody portion217 of the attachment member may, in the illustrated embodiment, include a threaded portion (e.g., male thread260) operable to engage a corresponding threaded portion (e.g., female thread258) of thehousing220 as shown inFIGS. 3,4,6, and7A.
• As evident in the figures, thebody portion217 may be of larger diameter that theengagement portion219 to accommodate various components of thefirst coupler204. For example, thebody portion217 may be sized to receive aseal238 within thepassageway221. Theseal238 preferably includes a lumen that extends completely through the seal. The lumen of the seal may be configured to receive theproximal end116 of thecatheter108 and form a substantially leak-free seal therewith. In one embodiment, theseal238 may include a generally compliant body (e.g., made from silicone or similar material) configured to surround theend116 of thecatheter108, and an optional rigidtubular member240 positioned within the lumen, e.g., proximate one end of the compliant body. The rigidtubular member240 may serve various purposes including, for example, preventing Occlusion of the lumen of theseal238 as the seal is compressed. Moreover, themember240 may provide an abutting surface against which theproximal end116 of thecatheter108 may seat during assembly of thefirst coupler204.
• Thetubular member240 may be made from most any material that can hold its shape as theseal238 is compressed. Exemplary materials include polysulfone and polycarbonate. Thetubular member240 may be attached to the body of the seal (e.g., adhesive, interference fit), or it may be held in place merely by contact between the inner surface of thepassageway221 and a step surface formed in the seal body.
• FIG. 6 provides an exploded view of thefirst coupler204. As shown in this view, theseal238 may include atapered surface242 to seat against a corresponding tapered surface within thepassageway221 of theattachment member218 as shown inFIGS. 3 and 4. Thefirst coupler204 may also include acollet244 located within thepassageway221 of theattachment member218. Thecollet244 is configured to, in conjunction with thehousing220, compress theseal238 and clamp or otherwise immobilize thecatheter108. Thecollet244 may include apiston246 that abuts theseal238, and asplit rod248 operable to receive thecatheter108 therein. Thecollet244 may further include acollet passageway250, extending through the collet (e.g., through thepiston246 and split rod248), through which thecatheter108 may pass as shown inFIGS. 3 and 4. Thecollet244 may be made from a material similar to that of thebody205.
• As further described below, thecollet244 may translate within theattachment member218. To limit the range of travel of the collet, a stop or stopmember252 may be provided.FIG. 6 illustrates that thestop member252 may include ears254 (only one shown) configured to engage openings256 (only one shown) in thebody portion217 of theattachment member218. Once theears254 are engaged with theopenings256, thestop member252 generally limits travel and prevents removal of thecollet244 from the attachment member218 (unless the stop member is first removed).
• As with the other components of thefirst coupler204, thehousing220 may define apassageway262 extending completely through the component to permit passage of thecatheter108. At the outermost end of thehousing220, e.g., where the catheter exits, thepassageway262 may flare to form a bell-mouth opening264. The large radius of the bell-mouth opening264 may reduce strain on thecatheter108 during the implantation period.
• The portion of thepassageway262 opposite the bell-mouth opening264 may form a frusto-conical surface266 diverging towards thepiston246 of thecollet244 as shown inFIGS. 3 and 4. The frusto-conical surface266 is configured to contact two or more movable (e.g., deflectable)legs268 of thesplit rod248 of the collet as thehousing220 is threaded onto theattachment member218. As thesurface266 contacts thelegs268, the legs may be directed inwardly towards thecatheter108. Thelegs268 may mechanically (e.g., frictionally or via a biting or clamping action) engage thecatheter108 when thehousing220 is fully engaged with theattachment member218 as described below. In the illustrated embodiment, thelegs268 may include protrusions270 (seeFIG. 7C) to assist with engagement of thecatheter108.
• The frusto-conical surface266 of the housing may also terminate at an abutting surface configured to contact and push against thepiston246 of thecollet244. As a result, when thehousing220 is fully engaged with, e.g., threaded onto, theattachment member218, thecollet244 may both compress theseal238 against an inner surface of the attachment member, and mechanically engage thecatheter108.
• FIGS.6 and7A-7C illustrate assembly of thefirst coupler204. As shown in these views, theseptum230 and retainingmember234 may be secured within thepassageway221 of theattachment member218 as discussed above. Theseal238,collet244, and stopmember252 may then be placed into theattachment member218 and the stop member positioned such that theears254 engage theopenings256 as described above. To assist with aligning thestop member252 with theopenings256,grooves253 may be provided along the inside surface of theattachment member218 as shown inFIG. 7C.
• Once theseal238 andcollet244 are positioned, thehousing220 may be placed over theattachment member218 as shown inFIG. 7A. When thehousing220 is sufficiently engaged with theattachment member218,optional tabs271 may be inserted and secured within openings272 (only one opening shown inFIG. 6). Thetabs271 may protrude past the interior surface of thehousing220 such that, when the housing is unthreaded and withdrawn from theattachment member218, the tabs engage a raisedlip274 of the attachment member to prevent inadvertent component separation. Thetabs271 may secure to thehousing220 via most any acceptable method including, for example, adhesive or press fit.
• As illustrated in the figures, see, e.g.,FIG. 7C, thecollet244 may include clocking features (e.g., one ormore keys276 located on the outer surface of the piston246) that engage the attachment member218 (engage either or both of thekeyways253 andkeyways278 formed on the inner surface) and prevent relative rotation. The external surface of theattachment member218 may also include one or more keys280 (seeFIG. 6) that engage corresponding keyways (visible inFIG. 4) on an inner surface of thesecond coupler202 to prevent relative rotation of thecouplers202 and204 during use.
• At this point, thecatheter108 may be inserted into thefirst coupler204, via the bell-mouth opening264, until it bottoms out in the seal238 (e.g., contacts the tubular member240) as shown inFIG. 7A. Thecatheter108 may include markings, e.g., laser markings (further described below), that assist the clinician in determining if the catheter is fully inserted. Thehousing220 may then be moved until thefemale thread258 engages themale thread260 of theattachment member218. Subsequent threading of thehousing220 onto theattachment member218 results in compression of theseal238, thereby sealing the fluid path between thefirst coupler204 and thecatheter108.
• Moreover, relative movement between the housing and attachment member results in engagement of the frusto-conical surface266 with thelegs268 of thecollet244, which may eventually apply a mechanical force (e.g., a gripping or clamping force) to thecatheter108. The first coupler204 (e.g., the collet244) is preferably configured to ensure that the gripping force on the catheter is greater than the intended breakaway force of theconnector200. As a result, when a traction force is applied to thetube102 and thecatheter108, thecouplers202 and204 separate before thecatheter108 dislodges from the first coupler.
• Preferably, thelegs268 of thecollet244 are configured to engage and grip thecatheter108 only after theseal238 has been compressed. As a result, axial catheter movement resulting from seal compression may be accommodated before the collet immobilizes thecatheter108.
• Thecatheter108 may be configured such that it can be satisfactorily immobilized by thecollet244 without occlusion of the fluid passageway. For example, in one embodiment, the catheter could be made from an elastomeric material (pure or blended) such as a polymer, silicone, or the like. Exemplary embodiments of thecatheter108 are described in more detail below.
• Thetube102, may, on the other hand, be constructed from conventional medical tubing such as polyurethane, silicone, or co-extrusions such as silicone/nylon or silicone/polyurethanie. Alternatively, thetube102 could be made from plasticized polyvinyl chloride (e.g., flexible PVC). In one embodiment, thetube102 may have an inner diameter of about 0.07 millimeters (mm) to about 0.08 mm (e.g., about 0.076 mm) and an outer diameter of about 1.4 mm to about 1.5 mm (e.g., about 1.47 mm). While exemplary embodiments of the catheter and tube are so described herein, variations in material, construction, and size of thecatheter108 andtube102 are certainly possible without departing from the scope of the invention.
• Once thehousing220 is completely threaded onto theattachment member218, thefirst coupler204 is generally configured as shown inFIG. 4. Thesecond coupler202 may then be positioned proximate thefirst coupler204 such that thebore206 is generally aligned with theengagement portion219. The engagement portion may then be slid into thebore206 such that theroller304 contacts theouter surface222 of the engagement portion. This contact results in theroller assembly301, e.g., theroller304, being displaced outwardly (upwardly inFIG. 4) against the biasing force of thespring306. Theroller304 may then roll along theengagement surface224 until it reaches the rampedsurface228, at which point the roller may roll down the ramped surface and engage (contact) thegrooved surface226.
• The biasing force of thespring306 tends to keep theroller assembly301 engaged with thegrooved surface226 during operation. To prevent backlash in theconnector200, thesecond coupler202 and thefirst coupler204 may include corresponding abuttingsurfaces282 and284, respectively (seeFIG. 4), that contact one another once the couplers are fully connected as shown inFIG. 3.
• While not wishing to be bound to any particular embodiment, the roller assembly may utilize anaxle302 having a diameter of about 0.050 inches (in) and the roller304 (which may be made from acetal resin, PEEK, nylon, or the like) may have an outer diameter of about 0.09 in. In this embodiment, thegrooved surface226 may be recessed about 0.021 in below theengagement surface224, and the rampedSurface228 may form an angle of about 50 degrees from the engagement surface.
• As thesecond coupler202 is attached to thefirst coupler204, theneedle208 associated with the second coupler may pierce theseptum230 associated with thefirst coupler204, thereby providing a fluid path from thesecond tube102 to the first tube (e.g., the catheter108). As a result, therapeutic agent contained in the infusion pump106 (seeFIGS. 1A-1B) may be delivered to the body through thetube102 andcatheter108 in accordance with any desired infusion profile.
• Theretention device300 is configured to release thefirst coupler204 from thesecond coupler202 once a predetermined traction force (the “breakaway force”) is applied between the couplers, e.g., between thetube102 and thecatheter108. In the illustrated embodiment, various features affect the breakaway force including, for example, the depth of thegrooved surface226, the angle of the rampedsurface228, the diameter of theroller304, the friction of the roller about theaxle302, and the spring force of thespring306. While not wishing to be bound to any particular range of parameters, embodiments of the present invention may provide aconnector200 having a breakaway force of about 1 pound force (lbf) to about 10 lbf and, preferably about 1 lbf to about 5 lbf, and more preferably, about 1.5 lbf to about 3 lbf.
• When the predetermined traction force is reached, theroller304 may move radially outward as it rolls from thegrooved surface226, along the rampedsurface228, to theengagement surface224. Theroller304 may continue to roll along theengagement surface224 until the couplers separate.
• While described and illustrated herein utilizing theretention device300, other retention mechanisms are possible without departing from the scope of the invention. For example,FIGS. 8A and 8B illustrate analternate retention device400. In this embodiment, the device includes a roller assembly having anaxle402 and aroller404 rotatable about the axle. Theaxle402 may be formed as part of a spring clip, e.g., C-shapedclip406. Theclip406 may be configured to fit within acircumferential groove408 formed in thebody410 of a second coupler. Theroller404 may be similarly contained within aslot412 formed in the body. Thebody410, while only partially illustrated inFIGS. 8A and 8B, is understood to be substantially similar to thebody205 of thecoupler202 described above (e.g., it includes abore414 to receive theattachment member218 substantially as described above). Asleeve416 similar to thesleeve216 already described herein may also be included.
• As with theretention device300, the roller assembly, e.g.,roller404, may include acontact surface418 formed by the outer surface of the roller. Thecontact surface418 may form a secant through thebore414 of thetubular body410 when the roller is in a first position as shown inFIG. 8B. When the attachment member is inserted into thebore414, theroller404 may move to a second position (see broken line representation of axle402) wherein the contact surface is located outside of the bore. Movement of theroller404 may be accommodated via deflection of theclip406 as may occur during insertion and removal of thefirst coupler204 from thebore414.
• As with thedevice300, thedevice400 may engage theouter surface222 of the attachment member218 (seeFIG. 4) in rolling contact. Moreover, theroller402 may be biased in a generally radial direction to maintain rolling contact with theattachment member218 of the first coupler during insertion/removal.
• Connectors in accordance with embodiments of the present invention provide tubing/catheter couplers that breakaway or separate from one another when a predetermined traction force is applied to the couplers and/or to their associated tubes/catheters. Moreover, the retention device that interconnects the two couplers may minimize frictional engagement therebetween by providing rolling contact engagement. As a result, the breakaway force required to separate the couplers is substantially repeatable, avoiding the variability commonly associated with friction-based retention interfaces. Connectors in accordance with embodiments of the present invention further provide an upstream coupler (e.g., a coupler attached to an implanted catheter) that minimizes exposure to contamination even when the couplers of the connector separate. Accordingly, replacement or sterilization of the upstream catheter and/or coupler may be unnecessary in the event inadvertent separation of the connector occurs.
• Connectors in accordance with embodiments of the present invention further provide a fluid flow path with minimal dead volume (the static volume that is filled before fluid is transferred through the connector). Reduced dead volume is advantageous as it may decrease the volume of wasted therapeutic agent. In the illustrated embodiment ofFIG. 3, the connector (e.g., theregion286 between thesecond tube102 and theneedle208, and theregion288 between theseptum230 and the seal238) is designed to provide a low dead volume. For instance, connectors in accordance with embodiments of the present invention may have a dead volume of less than20 microliters, and preferably less than 10 microliters, e.g., nominally about7 microliters.
Catheters
• As described above, the first tube orcatheter108 may be implanted and used to deliver the therapeutic agent to the body. Accordingly, thecatheter108 may be configured such that it can be satisfactorily immobilized by thecollet244 without occlusion of the fluid passageway. For example, as stated above, the catheter could be made from an elastomeric material (pure or blended) such as a polymer, silicone, or the like.
• While some exemplary catheters may be constructed as generally uniform tubes, catheters in accordance with other embodiments of the invention may be configured to include an elongate tubular core or core member107 (see, e.g.,FIG. 7A) made from longitudinally flexible tubing that is resistant to compression and collapse, e.g., glass (e.g., silica or quartz) tubing, PEEK tubing, or stainless steel tubing.FIGS. 9A-9B illustrate an exemplary catheter having such a construction.
• Thecore107 may include a proximal end positioned at or near theproximal end116 of thecatheter108, and a distal end positioned at or near thedistal end110 of the catheter as shown inFIG. 9A. Thecore107 may also include a tubular body forming alumen117 spanning between the proximal and distal ends of the core. In the illustrated embodiment, thetubular core107 may have an inner (e.g., lumen117) diameter of about 80 micrometers to about 120 micrometers (e.g., about 100 micrometers) and an outer diameter of about 200 micrometers (e.g., about 193 micrometers), yielding a radial or wall thickness of about 50 micrometers or less. Anexemplary core107 may be a flexible synthetic fused silica capillary having an optional thin protective polymer (e.g., polyimide) coating (forming an intermediate layer between the core and an outer covering or jacket109) such as the TSP line of products sold by Polymicro Technologies, LLC, of Phoenix, Ariz., USA.
• The flexible outer covering orjacket109 may be formed over thetubular core107, e.g., it may surround the tubular core and be secured or otherwise fixed relative to the core's outer surface. While the flexible outer covering or jacket is described in the illustrated embodiments as anelastomeric jacket109, this construction is not limiting as other outer covering embodiments are certainly possible without departing from the scope of the invention.
• In one embodiment, thejacket109 may have an outer diameter that is about 3 or more times larger, and preferably about 4 or more times larger (e.g., about 4 to about 6 times larger), than the outer diameter of thetubular core107. For example, the outer diameter of thejacket109 may be about 0.8 mm to about 1.2 mm (e.g., about 1 mm).
• Thejacket109 may be formed of an elastomeric material having a radial compliance that is greater than a radial compliance of thetubular core107. In one embodiment, theelastomeric jacket109 is made from a material selected from the group consisting of polyurethane and silicone. As a result of using a relatively compliant material, the flexible outer covering or jacket may permit high mechanical clamping/indentation forces to be applied to the catheter108 (e.g., by theconnector200 or, as described below, by the anchor1200) to immobilize it, while the more radially rigidtubular core107 prevents catheter occlusion under such high forces. While not limited to any particular hardness, thejacket109 may, in one embodiment, have a hardness of about 50 to about 60 Shore D, e.g., about 55 Shore D (at the completion of manufacture).
• As illustrated inFIG. 9A, thetubular core107 may, in some embodiments, protrude longitudinally beyond the jacket or covering109 at one or both ends of the catheter (e.g., beyond adistal end119 of the jacket as shown) by adistance124 of, e.g., about 10 mm or more. Stated alternatively, thejacket109 may terminate a distance of about 10 mm short of the distal end of thecore107.
• FIG. 9B illustrates a section view of thecatheter108 taken alongline9B-9B ofFIG. 9A. As illustrated in this view, the catheter may optionally include one or more locator markings. For instance, a marker band, e.g., a fluoroscopic orradiopaque marker band131, may be located at or near thedistal end119 of the outer covering (e.g., jacket109). Theband131 may include platinum, iridium, or a similar material that may permit detection of the band with fluoroscopic or x-ray imaging. Such a configuration may be beneficial, for example, during implantation of the catheter into the body.
• Thecatheter108 may further optionally include other locator markings, e.g., longitudinal markings132 (only two shown oncatheter108 inFIG. 9A). Thelongitudinal markings132 may be evenly spaced and include some colorant (e.g., titanium dioxide) to permit visual indication of catheter implant depth. Themarkings132 may also be used to determine proper placement of theproximal end116 of the catheter within theconnector200.
• FIGS. 10A-10E illustrate a catheter, e.g., acatheter508, in accordance with an alternative embodiment of the invention. Thecatheter508 may be similar in some respects, and be used in place of, thecatheter108.
• Like thecatheter108, thecatheter508 may include a radially rigid yet longitudinally flexible tubular core or core member507 (of a first material, e.g., PEEK tubing) having a distal end and a proximal end. A flexible outer covering orjacket509 may surround the core (see, e.g.,FIGS. 10A and 10D). However, instead of a single tubular core member extending along the catheter, thecatheter508 may incorporate a separate tubular tip ortip member510, e.g., a composite tip member made of a second material different than a material of thecore member507. Thetip member510, like thecore507, may also have proximal and distal ends as shown inFIG. 10A.
• Thetip510 may be configured as a relatively rigid (both radially and longitudinally) member. For instance, in one embodiment, thetip510 may be formed from fused silica glass tubing. In another embodiment, thetip510 may be made from steel, e.g., type304 stainless steel hypodermic tubing. The proximal end of thetip510 may be positioned to abut the distal end of the core507 (e.g., be positioned in abutting contact atlocation511 as illustrated inFIGS. 10A and 10B) such that a generally continuous lumen extends or is established from the proximal end of the core507 to the distal end of thetip510. While described herein as abutting one another, in practice the twomembers507 and510 may have a small gap therebetween, e.g., the adjacent ends of the tip and core may be positioned to be near, rather than abut, one another. Nonetheless, thejacket509 may effectively seal the interface and provide a generally continuous lumen as described.
• While not wishing to be bound to any particular construction, the materials and geometry of thetip510 andcore507 may be selected to produce a bending stiffness ratio (ratio of the bending stiffness of the tip to bending stiffness of the core) of about 24:1.
• Thejacket509 may surround or encase longitudinal sections or portions of both thetip510 and thecore507 as further described below. As with thecatheter108, the distal end of thetip510 may protrude a preset distance beyond a distal end of the jacket as shown inFIG. 10A. Thetip510 may also extend into the jacket509 a distance that is sufficient to ensure retention of the tip. For example, in one embodiment, the catheter length (including the protrudinglength124 of the tip510) is about 400 mm (about 16 inches), while the tip extends into the jacket adistance134 of about 20 mm, (about 0.8 inches).
• FIG. 10C illustrates a cross section of thecatheter508 taken alongline10C-10C ofFIG. 10A, whileFIG. 10D illustrates a section view of the distal end of thejacket509. These views clearly illustrate the marker band131 (as described above) formed, at least in one embodiment, as a ring located around thetip510 and surrounded by thejacket509. In one embodiment, the marker band may extend ashort distance136, e.g., about 1 mm, from the end of the jacket. As with thecatheter108, thecatheter508, e.g.,jacket509, may also include the longitudinal length markings132 (only two shown inFIG. 10E). Themarkings132 andband131 may be visible from any radial position, e.g., they may extend360 degrees around the catheter.
• In still yet other embodiments, strengthening members, e.g., braided members helically-wound about a longitudinal length or portion of the catheter, and/or straight longitudinal members, may be provided. For example, strengthening members may be sandwiched between the core and the flexible outer covering or jacket (e.g., such that they are surrounded by the jacket), or alternatively embedded within the jacket. Exemplary strengthening members may include polyester (e.g., polyethylene terephthalate (PET)), synthetic polymers such as Kevlar brand fiber (sold by E.I. du Pont de Nemours of Wilmington, Del., USA), and liquid crystal polymers. In other embodiments, steel may be used to form the strengthening members. Such strengthening members may be incorporated into any of the catheter embodiments (e.g.,108,508, and608, the latter of which is described below) described herein.
• Anexemplary catheter608 incorporating such strengthening members is shown inFIGS. 11A-11E. Thecatheter608 may be similar in most respects to thecatheter508. For instance, it may include a core or core member607 (e.g., PEEK core) and a flexible outer covering or jacket (e.g., polyurethane jacket)609 optionally having locator markings such asmarker band131 and longitudinal markings (not shown) as already described herein. As a result, a section taken throughline11D-11D (seeFIG. 11D) is similar in most respects to the corresponding section taken throughline10C-10C ofFIG. 10A (see, e.g.,FIG. 10C).
• Atip610 substantially similar to thetip510 already described above may also be included. Thejacket609 may encase at least sections of both thecore607 and thetip610 as further described below. Once again, as shown inFIG. 11B, thetip610 may abut thecore607 at a location611 (e.g., offset adistance634 from the distal end of the jacket) such that a continuous lumen is formed through the catheter. Thetip610 may further extend from the distal end of the jacket by adistance124 as already discussed above.
• Unlike thecatheter508, however, thecatheter608 may further include one ormore strengthening members605 extending along at least a portion of a length of the catheter. In the illustrated embodiment, the strengtheningmembers605 may form a tubular braid located coaxially about portions of one or both of thecore607 and the tip610 (note: themembers605 are shown diagrammatically in the figures). Stated another way, theindividual members605 may include a plurality of first braidedmembers605ahelically wound about a longitudinal portion of the catheter608 (e.g., about at least portions of the core and/or the tip510) in a first or clockwise direction, and a plurality of second braidedmembers605bhelically wound about the longitudinal portion in a second, opposite or counterclockwise direction (as shown inFIG. 11C) such that individual members interweave with one another. Other embodiments may include, alternatively or in addition, one or morelongitudinal strengthening members606 extending along portions of one or both of the core and the tip as also shown inFIG. 11C.
• In one embodiment, the strengthening members605 (e.g., themembers605aand605b) include sixteen separate, 0.05 mm (0.002 inch) diameter PET fibers that are partially embedded within thejacket609 as shown inFIGS. 11C and 11E, the latter of which is a section view taken alongline11E-11E ofFIG. 11B. These strengtheningmembers605 may extend along at least a portion of thecatheter608. For example, in the embodiment illustrated inFIG. 11A, themembers605 may terminate adistance138 short of the distal end of thejacket609. The strengtheningmembers605 may also extend towards the proximal end of the catheter at least beyond the location611 (e.g., so that they surround the distal end of thecore607 and the proximal end of thetip610 as shown) to increase strain relief to the catheter in the vicinity of thelocation611. In the illustrated embodiment, the strengtheningmembers605 may extend to the proximal end of thecatheter608.
• While not wishing to be bound to any particular embodiment, theexemplary catheter608 may again be about 400 mm (16 inches) long (including the protruding tip610). The distance138 (the termination offset of the strengtheningmembers605 from the distal end of the jacket609) may be about 10 mm (0.4 inches), while thedistance634 at which thecore member607 abuts the tip member, may be about 20 mm (0.8 inches). Thepreset distance124 may again be about 10 mm (0.4 inches), which may thus be equal to about ⅓ of the total length of thetip member610. The small diameter, protruding distal tip of the core may assist in, for example, penetrating tissue during implantation.
• The catheter embodiments illustrated inFIGS. 10A-10E and11A-11E may provide a catheter having: adistal end section140 defined by the protruding (e.g., stainless steel or glass)tip member610; aproximal end section142 defined by the portion of the catheter incorporating thecore member607; and amedial section144 between the distal and proximal end sections (see, e.g.,FIG. 11A). Thejacket609 may extend along and surround both themedial section144 and theproximal section142. Thedistal end section140 may thus have a longitudinal portion with a uniform outer diameter less than an outer diameter of one or both theproximal end section142 and themedial section144. As a result of the different material of thecore607 andtip610, thedistal end section140 may also have a bending stiffness that is greater than a bending stiffness of theproximal end section142.
• The outer covering orjacket109 may be applied to the respectivetubular core107 in any known fashion (the following description may also apply to thejackets509 and609 and theirrespective cores507 and607). For example, it may be applied over thecore107 through a secondary extrusion process. Alternatively, the outer covering orjacket109 may form a tube which slides over thetubular core107 with clearance. In the case of the latter, two or more abutting tubing segments may be employed to produce thejacket109. These multiple segments may also be beneficial in providing the proper spacing for thelongitudinal markings132. A shrink-wrap tube may then be placed over the assembled tubes and the entire assembly heated. Any optional strengthening members (e.g., woven fibers605) may also be placed over thetubular core107 or theouter covering109 before the heat shrink tube is applied. Subsequent heating of the assembly may cause theouter covering109 to melt and the shrink-wrap tube to constrict. Thus, the shrink-wrap tube may force the melted outer covering (and optional strengthening members) inwardly towards thetubular core107 and bond to the same. The shrink-wrap tube may then be removed to produce thecatheter108.
Anchors
• Embodiments of the instant invention may also be directed to anchor devices and assemblies and to corresponding systems and methods for securing a therapy delivery device relative to a surface, e.g., a surface of a body. For example, exemplary anchor assemblies and devices described herein may be configured to secure a therapy delivery device (such as a stimulation lead or infusion catheter108) that is partially implanted through a skin-covered body portal. Moreover, these anchor assemblies may be manipulated from a location outside of the skin (e.g., outside of the patient's body) to release the therapy delivery device, e.g., at therapy completion. Once released, the device may be withdrawn from the body, e.g., by application of an external force or other action. As a result, the therapy delivery device may be removed from the patient without a separate surgical procedure.
• While the term “skin” is used herein to identify an exemplary covering of the body portal, this term is not to be read in a limiting sense. That is, embodiments of the present invention are equally applicable to portals covered by most any material, including grafts, medical dressings, and other synthetic and biologic coverings, as well as to uncovered portals.
• In the described embodiments, an anchor portion of theanchor assembly1201 is configured as the burr hole anchor1200 (seeFIG. 1A). The anchor may be part of thesystem100 for infusing a therapeutic agent into the patient's brain via thebrain catheter108 passing through theburr hole112 formed in the skull. Theanchor1200, which may be subdermally located, may be used to secure the catheter relative to the burr hole. Theanchor assembly1201 may include theanchor1200 as well as thelock member1208 to release thecatheter108 from the anchor, e.g., at therapy completion.
• While described herein in the context of burr hole anchors and corresponding infusion systems, anchor assemblies and systems in accordance with embodiments of the present invention may find use in most any medical (or non-medical) application that involves access through a portal formed in a surface.
• FIGS. 1A and 1B illustrate the exemplary implantable medical system, e.g., braininfusion catheter system100. Once again, theexemplary infusion system100 may include the first medical tube, e.g., thebrain catheter108, partially implanted within thebody101. The secondmedical tube102 may also be provided having itsdistal end104 coupled to an external reservoir (e.g., infusion pump106) containing a volume of the therapeutic agent. In the illustrated example, thebrain catheter108 has an indwelling portion, e.g., thedistal end110, implanted through a body portal (e.g., burr hole112) and located at a predetermined location within thebrain114 of the patient. An external portion (e.g., the proximal end116) of thebrain catheter108 may be routable through skin covering the skull113 (seeFIG. 12) and extend outside the body161 where it connects to the correspondingproximal end118 of thetube102, e.g., via theconnector200.
• Thebreakaway connector200, as described above, may include the first coupler orconnector portion204 coupled to thebrain catheter108 and the second coupler orconnector portion202 coupled to thetube102 as shown inFIG. 1B. Once again, thefirst coupler204 may be operable to separate from thesecond coupler202 when a traction force applied between thetube102 and thebrain catheter108 reaches a predetermined threshold value. That is, theconnector120 may be configured to separate once a predetermined traction force is applied across the connector, e.g., between the twotubes102 and108 joined by the connector. Theconnector200 may utilize either frictional or non-frictional (e.g., magnetic) interfaces to achieve the breakaway function. As discussed above, the breakaway function may be beneficial to reduce inadvertent catheter dislodgement as the result of snagging of thetube102 orother system100 components on surrounding objects.
• As already described herein, theconnector200 may be supported, e.g., pivotally supported, by the optional headgear apparatus120 (seeFIGS. 1A and 2B) formed from a series of adjustable, fabric (e.g., nylon webbing) or elastic bands. Theheadgear apparatus120 may hold the connector, e.g., via a connection with thefirst coupler204, during the implantation. While illustrated as supported by theheadgear apparatus120 inFIG. 1A, theconnector200 could alternatively be generally unsupported, e.g., supported only by the free proximal ends116 and118 of thecatheter108 andtube102, respectively, without departing from the scope of the invention. Theexemplary breakaway connector200 is described elsewhere herein and in related U.S. patent application Ser. No. 11/589,694, filed on Oct. 30, 2006). While theexemplary connector200 is described herein, other embodiments that utilize connector configurations providing an alternate breakaway configuration are certainly possible. For example, connectors using a snap-fit lock (e.g., similar to that disclosed by Lickliter in U.S. Pat. No. 6,902,207) or those incorporating a magnetic lock (e.g., similar to that disclosed by Cator in U.S. Pat. No. 3,181,895) could be used.
• Thesystem100 illustrated inFIGS. 1A and 1B may further include a portal anchor device, e.g., theburr hole anchor1200. Theanchor1200 may attach to the body, e.g., to theskull113, in or near theburr hole112. Theanchor1200 may be used to selectively immobilize thecatheter108 relative to theburr hole112. In the illustrated embodiment, all, or substantially all, of theanchor1200 is positioned subdermally (e.g., below the skin). Theanchor1200 forms part of theanchor assembly1201 that further includes thelock member1208 capable of selectively releasing thebrain catheter108 from the anchor. The lock member (further described below) may be releasable, or otherwise actuatable, from a location outside of the skin.
• While the embodiments described and illustrated herein are directed to catheter implantation and anchoring, this is not limiting as most any other therapy delivery device (e.g., stimulation lead) may be used with the anchor embodiments described herein without departing from the scope of the invention.
• FIG. 12 is a perspective view of the portal, e.g., burr hole, site and illustrates an anchor system in accordance with one embodiment of the invention. Theburr hole112 may be formed through theskull113 in a known manner prior tocatheter108 implantation. In the illustrative embodiment, theanchor1200 includes a base1202 that at least partially surrounds the portal (burr hole112) and is attachable to tissue surrounding the portal, e.g., to theskull113, with fasteners, e.g.,bone screws1204, or the like. Theanchor1200 may further include a retainer1206 (shown exploded from the base inFIG. 12) that is attachable or otherwise securable to thebase1202 and is capable of selectively gripping or otherwise immobilizing thecatheter108. In some embodiments, thebase1202 may be optional. That is, theretainer1206 could be positionable in or near the burr hole portal beneath the skin, where it may be secured to the skull in another manner, e.g., friction. Theretainer1206 may include amovable arm1210 and a latch orlatching device1212, each of which is described in more detail below. The components of the retainer1206 (e.g.,body portion1230 and arm1210) may be constructed of most any biocompatible material, but are, in one embodiment, made from titanium.
• FIG. 13 illustrates a cross sectional view of theanchor assembly1201 andcatheter108 after implantation. As evident in this view, theanchor1200, e.g., thebase1202 andretainer1206, are operable to be subdermally located (i.e., beneath the skin111). AsFIG. 13 further illustrates, thearm1210 may move from a first or unlocked position shown inFIG. 12 (corresponding to the retainer being in a first or unlocked configuration), to a second or locked position shown inFIG. 13 (corresponding to the retainer being in a second or locked configuration). In the second position, opposing retainingsurfaces1234 and1242 (seeFIG. 14) may mechanically engage thecatheter108 and hold it in place relative to the burr hole1112. Thelock member1208 may be configured to hold or secure thearm1210 in the second position. Thecatheter108 and thelock member1208 may, at the completion of implantation surgery, extend outwardly through theskin111 covering theskull113 and the now-implantedanchor1200.
• FIG. 14 is a perspective view of the base1202 with theretainer1206 exploded to illustrate an exemplary construction. In this embodiment, theretainer1206 includes the planar, disk-shaped body orbody portion1230 that defines a mounting plane. Thebase1202 may form a peripheral portion of theanchor1200 that defines acentral opening1214. An inner surface of this peripheral portion may form aledge1216 to receive and support aperipheral edge1232 of thebody portion1230 when the retainer is attached to the base in or near the central opening.
• Theledge1216 may, in one embodiment, be formed by a plurality ofteeth1218 protruding from the inner surface of the peripheral portion into thecentral opening1214. Arecess1220 may be defined between adjacent pairs of the plurality ofteeth1218.
• Thebody portion1230 may further include afirst retaining surface1234 defined by an edge of a cutout or pie-shapedopening1236 extending through theperipheral edge1232. Thefirst retaining surface1234 may span from an interior of thebody portion1230 to a location at or near theperipheral edge1232. As further explained below, thefirst retaining surface1234 may be configured to mechanically engage the catheter108 (not shown inFIG. 14) during use.
• Thearm1210 may be movably, e.g., pivotally, attached to thebody portion1230. For example, thearm1210 may include asecond retaining surface1242 that joins first andsecond plate members1238,1240. Theplate members1238,1240 may form a clevis extending over both sides of thebody portion1230 when thearm1210 is assembled with the body portion.
• The twoplate members1238,1240 may includeopenings1244 that align with anopening1246 in thebody portion1230 such that apin1248 may be inserted through the openings (thepin1248 may engage either thearm1210 or thebody portion1230 with interference) as shown inFIG. 15. Thearm1210 may thus pivot about an axis of thepin1248. Thesecond retaining surface1242, e.g., thearm1210, is therefore movable, relative to the first retaining surface, between the first position configured to receive the catheter108 (see, e.g.,FIG. 15), and the second position configured to mechanically engage the catheter (e.g., via friction or via a biting or clamping action) against the first retaining surface1234 (see, e.g.,FIG. 16). Thus, thecatheter108 may be immobilized or otherwise locked relative to theanchor1200 via a pivoting motion applied to thearm1210.
• In embodiments wherein thecatheter108 is engaged via a biting action or a high frictional force, the catheter may be constructed of a compliant material that can withstand the contact forces of the first and second retaining surfaces as already described herein (see description ofcatheters108,508, and608).
• When thearm1210 is in the first position, thesecond retaining surface1242 may be oblique to thefirst retaining surface1234, e.g., a line contained within the second retaining surface may intersect a line contained within the first retaining surface at an acute angle. This configuration provides for a larger opening in which to initially insert and position the catheter as shown in FIG.15. However, when the arm is in the second locked position (see, e.g.,FIG. 16), the first and second retaining surfaces are generally parallel to one another to permit generally equivalent contact force on the catheter regardless of the catheter's position along the retaining surfaces.
• In addition to theanchor1200, theanchor assembly1201 may further include thelock member1208. Thelock member1208 may be formed by an elongate member orcord1250 that is removably coupled to the anchor, e.g., to thebody portion1230 of theretainer1206. In one embodiment, thelock member1208, e.g., thecord1250, protrudes away from thebody portion1230 generally orthogonally from the mounting plane defined by the body portion. Thecord1250, in the illustrated embodiment, is configured to protrude through an opening or incision in theskin111 as shown inFIG. 13. In one embodiment, theelongate cord1250 is made from stainless steel stranded cable, e.g., 1×7, 1/64 inch diameter.
• Theexemplary lock member1208 may also include afirst end1252 and asecond end1256. Thefirst end1252 may be attachable to thebody portion1230, e.g., detachably inserted into or otherwise received within anopening1254 formed in the body portion (see, e.g.,FIG. 14). Theopening1254 may position thelock member1208, e.g., thefirst end1252, such that it may interact with thearm1210 as further described below. In the illustrated embodiment, thelock member1208 is securely retained in thebody portion1230 during the implantation period and up until thelock member1208 is intentionally removed. Such secure retention may be achieved in any number or ways, some of which are described in more detail below.
• The first andsecond ends1252 and1256 of thelock member1208 may be formed bysleeves1252aand1256a,respectively, which are attached, e.g., crimped or adhered, to thecord1250. By utilizing thesleeve1252aat thefirst end1252, the tolerance of thefirst end1252 relative to theopening1254 may be closely controlled without concern for the size, material, or structure of thecord1250. In one embodiment, thesleeves1252aand1256aare made of stainless steel.
• Thesecond end1256, e.g., thesleeve1256a,of thelock member1208 may be used to provide a gripping surface to assist in lock member removal. In one embodiment, thesleeve1256amay be used to secure an optionalgrasping loop1258 as shown inFIGS. 12 and 14. Theloop1258 may be sized to permit insertion of a finger to assist the clinician with lock member removal.
• Thelock member1208 is movable from an engaged state in which the lock member is coupled to theretainer1206 to hold thearm1210 in the second position (see, e.g.,FIGS. 13 and 16), to a disengaged state in which the lock member releases the arm from the second position. Thelock member1208 is preferably movable from the engaged state to the disengaged state via manipulation of the lock member from outside the skin, e.g., via application of a traction force to thesecond end1256 of the lock member to remove the latter from theretainer1206.
• Thelock member1208 is configured to secure or lock thearm1210, e.g., thesecond retaining surface1242, in the second or locked position, as shown inFIG. 16, by engaging alocking portion1260 of the arm as further described below. While not visible inFIG. 16, the arm may include alocking portion1260 on both thefirst plate member1238 and the second plate member1240 (seeFIG. 20).
• Thelock member1208 may be retained within thebody portion1230 via a variety of methods. For example, in one embodiment, thefirst end1252 may be sized such that it is received into the opening with an interference or press fit, wherein the interference provides a suitable retention force. In another embodiment, theopening1254 may form a slot that receives thefirst end1252. Such a slot may provide advantages including added flexibility of thebody portion1230 during insertion/removal of thelock member1208. As a result, tolerance control between thefirst end1252 and thebody portion1230 could potentially be relaxed.
• In yet another embodiment, a cantilever spring may be provided that is integral or otherwise associated with theopening1254. The spring and opening may both provide a suitable retention force between thelock member1208 and thebody portion1230 without necessitating the elevated tolerance accuracy typically associated for press fits. In still yet another embodiment, thefirst end1252 of the lockingmember1208 may be sized to freely slip into theopening1254. The lockingportion1260 of eacharm1210 could then mechanically interfere with thefirst end1252 to provide a frictional retention force. In one embodiment, this retention force may be about 0.1 pounds force (lbf) to about 1.1 (lbf). However, this range is exemplary only and embodiments that release upon the application of most any force are certainly possible without departing from the scope of the invention. In this embodiment, each lockingportion1260 may basically form a cantilevered spring that allows insertion, despite the mechanical interference, of thefirst end1252 of thelock member1208 into thebody portion1230. In still other embodiments, a detent bump1261 (seeFIG. 16) may be provided that creates a detent action to releasably hold thearm1210 in the unlocked position. Due to the spring-like action of each lockingportion1260, a suitable detent holding force may be created.
• Theretainer1206 may further include thelatch1212 as shown inFIG. 14 (also shown in section inFIGS. 19A and 19B). Thelatch1212 may be used to secure theretainer1206 relative to thebase1202. While shown inFIG. 14 as a separate component attached to thebody portion1230, thelatch1212 could, in other embodiments, be formed as an integral part of the retainer, e.g., deflectable snap fit tabs as further described below.
• Thelatch1212 may include alatch plunger1262 that is biased outwardly by a biasing member, e.g.,spring1264. Thelatch plunger1262 may be formed by first andsecond plate members1266 and1268 that are joined at anose1270. A pin, e.g., retainingpin1271 may also extend between theplate members1266 and1268. Thelatch plunger1262 may thus form a clevis that extends over both sides of thebody portion1230 when assembled.
• Thelatch1212, e.g.,latch plunger1262, is preferably movable from a first or unlatched position that is at or within theperipheral edge1232 of the body portion1230 (see, e.g.,FIG. 15), to a second or latched position extending beyond the peripheral edge of the body portion (see, e.g.,FIG. 16). Thelatch plunger1262 is preferably biased towards the latched position by the biasing member (e.g., by the spring1264).
• A stop, such astab1272, may be provided on one of the plate members, e.g., thelower plate member1268. Thetab1272 may be used to hold thelatch plunger1262 in the unlatched position. For example, thetab1272 may include anopening1274 that aligns with anopening1276 in thebody portion1230 when the latch1212 (e.g., the latch plunger1262) is in the first unlatched position. Apin1278, which may be fixed (e.g., via interference or adhesive) within theopening1276, may then engage the opening1274 (preferably with clearance) to hold thelatch plunger1262 in place.
• Thebody portion1230 may further include an opening, e.g.,slot1280, that receives and retains thespring1264. Afinger1282 may extend into theslot1280 to assist with spring retention. The retainingpin1271, which may be installed when thelatch plunger1262 is in the first or unlatched position, may also extend through theslot1280. As a result, thepin1271 may limit the outward movement of thebiased latch plunger1262 and prevent component separation.
• Thebody portion1230 may define other features, e.g.,slots1284 and1285, that assist in assembly and/or manipulation of the retainer as further described below. Thearm1210 may also include aslot1286 that, in conjunction with theslots1284 and1285, assists in movement of the arm.
• FIG. 15 illustrates a perspective view of theanchor1200 with a portion of thebase1202 cut-away to show theledge1216 in more detail. In this view, thearm1210 is shown in the first or unlocked position and thelatch1212 is shown in the first or unlatched position. As illustrated in this view, thebase1202 may be of two-part construction. A first orinner portion1222 may form theledge1216 and its associated structure (e.g., the teeth1218) to support theretainer1206. A second orouter portion1224 may include features (e.g., fastener attachment points) that assist in attaching thebase1202 to tissue (bone surface) surrounding theburr hole112. Thefirst portion1222 may be relatively rigid (as compared to the second portion1224) to ensure that thecatheter108 is adequately immobilized. Thesecond portion1224 is preferably more compliant than thefirst portion1222. The compliance of thesecond portion1224 allows theanchor1202 to generally conform to the local shape of the skull113 (seeFIG. 12). In one embodiment, the first orinner portion1222 of thebase1202 is made from titanium, while the second orouter portion1224 is made from an implantable thermoplastic such as amorphous polyamide.
• Thesecond portion1224 may be pivotally coupled to thefirst portion1222 of thebase1202 via a ball and socket arrangement as shown in the cut-away portion ofFIG. 15. For example, the inner surface of thesecond portion1224 may include an innercircumferential lip1225 that is convex in cross section as shown inFIG. 15. Thislip1225 may fit within an outer circumferential recess of thefirst portion1222 that is concave in cross section as shown inFIG. 15. While thebase1202 is illustrated as having a two part construction, such a configuration is not limiting. For example, other embodiments of thebase1202 may utilize a single piece construction without departing from the scope of the invention. Such a single piece construction could include integral flexing elements, or flexures, to create a rigid portion and a conforming portion of thebase1202.
• Other variations of thebase1202 are also possible. For example, while not illustrated herein, thebase1202 could be formed with a radial slot extending entirely through the ring that forms the base (e.g., yielding a C-shaped base). Such a construction may allow side loading of the base1202 over thecatheter108 after the catheter is positioned but before the stereotactic positioning apparatus is removed.
• FIG. 16 illustrates theanchor1200 of theanchor assembly1201 with thelatch1212 in the latched position and with thearm1210 in the locked position. In the locked position, thearm1210, e.g., thesecond retaining surface1242, mechanically engages thecatheter108 by clamping or pinching the catheter against thefirst retaining surface1234. To reduce stress on thecatheter108,curved transition surfaces1226 associated with either or both the first andsecond retaining surfaces1234 and1242 may be provided. As further shown in this view, the locking portion(s)1260 of thearm1210 may be configured to contact the lock member1208 (when the arm is in the locked position) such that the arm is immobilized relative to thebody portion1230 of theanchor1200.
• To further illustrate the movement of thearm1210,FIGS. 17 and 18 provide top views of theanchor assembly1201.FIG. 17 illustrates the anchor assembly with the arm in the unlocked position and the latch in the latched position, whileFIG. 18 illustrated the anchor with the arm in the locked position and the latch in the latched position (thecatheter108 is removed from these views for clarity). As illustrated inFIG. 17, the lockingportion1260 may form a resilient finger that may deflect to rest against thelock member1208, e.g., against thefirst end1252, when the arm is in the first or unlocked position. During the implantation procedure, the arm may be moved (e.g., pivoted about the pin1248) to the locked position ofFIG. 18 once thecatheter108 is located at the desired position within thecentral opening1214. Thearm1210 may be moved to the locked position by, for example, inserting an instrument such as forceps into theslots1284,1285, and1286 and drawing thesecond retaining surface1242 of the arm towards thefirst retaining surface1234. A stop member, e.g., aprotrusion1289 formed on thebody portion1230, may be provided to limit the movement of thearm1210 towards the first retaining surface, thus providing protection against catheter over-compression.
• When the arm reaches the locked position shown inFIG. 18, the locking portion(s)1260 of thearm1210 may slide past thefirst end1252 of thelock member1208. When the lockingportion1260 clears thefirst end1252, it may return to an undeflected state. In this undeflected state, each lockingportion1260 of thearm1210 is aligned with thefirst end1252 of thelock member1208 such that a lock surface1290 (seeFIG. 17) abuts the first end of the lock member as shown inFIG. 18. In the illustrated embodiment, thelock surface1290 could be concave in shape to seat against the cylindrical shape of thefirst end1252 of thelock member1208 when the arm is in the second position. Alternatively, thelock surface1290 may be formed by one or more linear surfaces tangent to thefirst end1252 as best illustrated inFIGS. 17 and 20. When thelock surface1290 is engaged with thelock member1208, thearm1210, e.g., thesecond retaining surface1242, may be held in the locked position shown inFIG. 18.
• As mentioned above, thelock member1208 may be retained in thebody portion1230 with an interference fit. However, in some instances, e.g., when thearm1210 is in the locked position as it is during infusion, it may be beneficial to increase the lock member retention force. Accordingly, some embodiments of thecatheter108, as already described herein, may be constructed with a lumen that is relatively rigid in (e.g., resistant to) radial compression. Such a catheter construction may increase the force applied to thefirst end1252 of thelock member1208 by the lockingportion1260, and thus increase frictional retention of the first end within theopening1254 of thebody portion1230. In one embodiment, the retention force, e.g., the force required to remove thefirst end1252 from thebody portion1230, may be about 0.1 lbf to about 3 lbf, e.g., about 0.5 lbf to about 2 lbf.
• Prior to moving thearm1210 to the locked position as described above, theretainer1206 may first be latched or secured to thebase1202 using thelatch1212. Preferably, theretainer1206 is secured to the base with thelatch1212 before locking of thearm1210 to prevent undesirable transverse catheter movement during retainer latching.
• FIG. 19A is a section view of theanchor1200 taken alongline19A-19A ofFIG. 17 illustrating thelatch1212 in accordance with one embodiment of the invention. However, unlikeFIG. 17,FIG. 19A shows the latch in the first or unlatched position, whileFIG. 19B shows generally the same view asFIG. 19A, but with the latch in the second or latched position (e.g., a true section view ofFIG. 17).
• As illustrated inFIG. 19A and described above, theretainer1206 may be located within thecentral opening1214 of thebase1202 where it may be positioned to rest upon theledge1216. Once theretainer1206 is rotationally positioned, relative to thebase1202, to the desired orientation, thelatch1212 may be released to secure the retainer in place. In the illustrated embodiment, thelatch1212 may be released by releasing thetab1272 from thepin1278. Release of thetab1272 may be accomplished by inserting a surgical instrument, e.g., forceps, through theslot1284 and applying a slight downward force to the tab as represented byarrow1287 inFIG. 19A. Alternatively, a specialized tool (not shown) may be used. This tool may provide a properly-sized actuator point, as well as an inherent limit stop, both of which may assist in the release of thetab1272. The force may deflect thetab1272, as illustrated by the broken line representation inFIG. 19A, sufficiently for the tab to release from thepin1278. Once thetab1272 is released, thespring1264 forces thelatch plunger1262 away from thebody1206 of theretainer1206. That is, the spring pushes theplate members1266,1268 and thenose1270 outwardly towards thebase1202.
• As thelatch plunger1262, e.g., thenose1270, extends towards theinner portion1222 of thebase1202, thespring1264 also forces thebody portion1230 against the opposite side of the base as shown inFIG. 19B. When thelatch1212 is fully released or engaged (as shown inFIG. 19B), thenose1270 and thebody portion1230 are pressed against opposing inner surfaces of thebase1202.
• As illustrated inFIGS. 19A and 19B, thebase1202 may define agroove1291 bounded by theledge1216 and by anupper surface1292. The ledge and the upper surface substantially restrain theretainer1206 against movement normal to the mounting plane of the body (i.e., along an axis of the central opening). Similarly, the biasing force of thespring1264 may substantially restrain theretainer1206 against radial movement relative to thebase1202. Alternatively (or in addition), a portion of the retainer (e.g., the pin1278) may form a stop that limits movement of thelatch plunger1262 away from the latched position. This is accomplished, in one embodiment, by anend1273 of thetab1272. Theend1273 may abut thepin1278 when movement of thelatch plunger1262 away from the latched position occurs, thus assisting with maintaining the latch in the latched position. As a result, theretainer1206 may be secured within the central opening of thebase1202 via thelatch1212.
• FIG. 20 illustrates a bottom plan view of the anchor after thelatch1212 is moved to the second or latched position ofFIG. 19B and before the arm is moved to the locked position. As illustrated in this view, thelatch plunger1262 of thelatch1212 may force theretainer1206 to a location slightly off-center from thebase1202 such that the retainer and base are no longer concentric. As theretainer1206 is shifted transversely to the base, lock members, e.g.,tabs1294 and1296, attached to thebody portion1230 may each engage one of therecesses1220 of the base as shown. Engagement of thetabs1294,1296 with the recesses may reduce or eliminate excessive rotation of theretainer1206 relative to the base.
• Embodiments of the present invention may further include methods for delivering therapy via a partially implanted device extending through a covered portal such as the skin-coveredburr hole112. For example, an exemplary method may include securing the device (e.g., catheter108) relative to theburr hole112 with thesubdermal anchor1200. Securing thedevice108 relative to theburr hole112 may be accomplished by clamping the device between opposing retainingsurfaces1234,1242 of theanchor1200 during implantation as described above. Theanchor1200 may be attached to bone (e.g., to the skull) surrounding the burr hole, wherein thedevice108 protrudes outwardly through theskin111. The method may further include releasing thedevice108 from theanchor1200 by manipulation of the anchor from outside theskin111. In one embodiment, releasing thedevice108 includes applying a release (e.g., traction) force to thelock member1208 protruding outwardly through the skin and removing the lock member from theanchor1200. By then applying a force (e.g., traction force) to a portion of thedevice108 that protrudes outside the skin, the device may be removed entirely from the patient.
• In other embodiments, methods for removing a partially implanted device (such as the catheter108) extending through the skin-covered burr hole are provided. For example, in one embodiment, the method may include applying a release (e.g., traction) force to a lock member (e.g., lock member1208) extending through theskin111, wherein the lock member is coupled to thesubdermal anchor1200 that is used to immobilize the device relative to theburr hole112. The lock member may be detached from theanchor1200 and withdrawn through the skin. By then applying a force (e.g., traction force) to a portion of thedevice108 protruding outside the skin, the device may be removed entirely from the patient through the skin.
• FIGS. 21A-21D illustrate an exemplary method of using theanchor assembly1201 to secure and release thecatheter108 from within the burr hole. After peeling theskin111 back to expose theskull113 as shown inFIG. 21A, theburr hole112 may be formed at a predetermined location in accordance with conventional practices. Thebase1202 of theanchor1200 may then be attached to theskull113. To assist with attachment of the base, anattachment tool1295 may be provided. The attachment tool may interlock with thebase1202 and align the latter with theburr hole112. Once aligned, theattachment tool1295 may also support and align the bone screws1204 that are used to secure thebase1202 to theskull113.
• Once the base is attached to the skull and thetool1295 is removed, thecatheter108 may be inserted through theburr hole112 until the tip is located at the desired location within the brain. Catheter insertion and positioning may be accomplished with stereotactic instrumentation (not shown).
• While thecatheter108 is supported with the stereotactic instrumentation, the retainer1206 (assembled as shown inFIGS. 12 and 21 B with the arm in the first or unlocked position and thelatch1212 in the first or unlatched position) may be side-loaded around thecatheter108 as shown inFIG. 21B such that the catheter enters the retainer via theopening1236. The retainer1206 (with thelock member1208 attached) may then be set into thebase1202 where it may seat upon theledge1216 as already described herein.
• Because thecatheter108 position within theburr hole112 may vary depending on the targeting procedure utilized, theretainer1206 is preferably operable to be rotated about its center axis. That is, theretainer1206 may be rotated within thebase1202 until thefirst retaining surface1234, at some location along its length, approaches or contacts thecatheter108. At this point, thelatch1212 may be activated to release thelatch plunger1262. As described above, thelatch1212 may be activated by inserting forceps or the like (not shown) into the slot1284 (see, e.g.,FIG. 17) to disengage thetab1272 from the pin1278 (see, e.g.,FIG. 19A). Once released, thelatch1212 may secure the retainer within thebase1202.
• With theretainer1206 secured, thearm1210 may be moved from the first unlocked position (see, e.g.,FIG. 17) to the second locked position (see, e.g.,FIG. 18). As described above, movement of the arm between the first and second positions may be accomplished by grasping theopenings1284 and1286 with forceps and applying a closing force.
• Once thecatheter108 is secured, the stereotactic instrumentation may be removed. After placing theskin flap111 over the anchor, the incision may then be closed as shown inFIG. 21C. Two openings or punctures may be formed in the skin flap to permit the passing of thecatheter108 and thelock member1208 through the skin. For example, one possible technique may involve piercing the skin from the outside with a needle or the like (e.g., Touhy needle), after which the catheter108 (or lock member1208) may be fed through the needle. The needle may then be withdrawn, leaving the catheter108 (or lock member1208) extending through the skin opening. Thecatheter108 may then be connected to theinfusion pump106, e.g., via theconnector200 andsecond tube102 as illustrated inFIG. 1A. Infusion of the therapeutic substance in accordance with a desired therapy delivery profile may then commence.
• While not illustrated, other components may be utilized to reduce bending stress on thecatheter108 during implantation. For example, an elastomer (e.g., silicone rubber) strain relief plate or disk (not shown) may be attached to the surface of the skin (e.g., with adhesive or dressing). The strain relief plate may include an opening and/or a shaped guide slot through which thecatheter108 may pass. The opening/slot preferably holds the catheter as it is draped around the scalp and may reduce bending stress on the catheter in the event that the catheter is inadvertently pulled at an angle. The plate member may also include an opening for thelock member1208 to pass. In other embodiments, the entire burr hole site may be dressed or bandaged. The bandage may include taping of the catheter to the body of the patient so as to provide the desired strain relief.
• At, before, or after completion of therapy delivery, thelock member1208 may be removed or detached from the anchor (e.g., removed from theopening1254 in the body portion1230) and withdrawn through theskin flap111 by, for example, application of a release (e.g., traction) force from outside thebody101 as represented byarrow1297 inFIG. 21D. Removal of thelock member1208 permits thearm1210 to release its mechanical engagement force on thecatheter108. Accordingly, the catheter may be subsequently removed from the patient by the application of a force applied to the catheter as represented byarrow1298. Depending on the size of thelock member1208 and thecatheter108, theskin punctures122 remaining after device removal may require suturing. However, in other embodiments, the size of the both components is sufficiently small such that no sutures are required.
• While described above in terms of passing thecatheter108 andlock member1208 through separate openings or punctures, other embodiments are also possible. For example, thecatheter108 and/orlock member1208 may extend through the skin at the original skin flap incision. Alternatively, the catheter and lock member could be routed through a single opening or puncture. In still another embodiment, thecatheter108 could be tunneled beneath the skin to a remote location.
• FIGS. 22A-22B illustrate ananchor assembly1301 in accordance with another embodiment of the invention. Theanchor assembly1301 may include ananchor1300 that is similar to theanchor1200 described above. For example, it may include abase1302 attachable to the skull withfasteners1304, and aretainer1306 having a movable, e.g., pivoting,arm1310. Thearm1310 may include first andsecond plate members1338,1340 (thelower plate1340 is illustrated inFIG. 24A) and locking portions1360 (seeFIG. 23) that are similar in most respects to the respective components of theanchor1200 described above. Thearm1310 may include anintegral pin1348 formed upon an extension of thelower plate1340 that engages a corresponding opening in a body orbody portion1330 of theretainer1306 to permit pivotal motion. Thearm1310 is illustrated in a first or unlocked position inFIGS. 22A-22B. As with theanchor assembly1201, theanchor assembly1301 may further include alock member1308 similar in most respects to thelock member1208 already described herein.
• Thebase1302 may also be similar in most respects to thebase1202. For example, it may define acentral opening1314 to receive theretainer1306. An inner edge ofbase1302 may have acircumferential groove1391 formed therein. Thegroove1391 may be similar in many respects to thegroove1291 described above. For example, it may define aledge1316 upon which the retainer may seat. However, unlike thegroove1291, thegroove1391 may not require teeth (e.g., teeth1218) as theretainer1306 utilizes a latch of a different configuration.
• The latch may, in the illustrated embodiment, be formed byflexible tabs1312 located on aperipheral edge1332 of thebody portion1330 of theretainer1306. Thetabs1312 may deflect to permit retainer insertion into thegroove1391, whereafter the tabs may return to their undeflected positions. As a result, theretainer1306 may be biased against the opposite side of the base1302 as shown inFIG. 22B. Accordingly, like thelatch1212, the tabs1112 are capable of biasing theretainer1306 into thegroove1391 to generally secure the retainer relative to thebase1302. The spring force of thetabs1312 is preferably sufficient to ensure little or no notable rotation between theretainer1306 and thebase1302.
• FIG. 23 is an enlarged perspective view of theanchor1300 with thearm1310 shown after pivotal movement to a second or locked position to secure thecatheter108. As with theretainer1206, thebody portion1330 of theretainer1306 may form afirst retaining surface1334 while thearm1310 forms asecond retaining surface1342. When thearm1310 is in the first position illustrated inFIG. 22B, thesecond retaining surface1342 may be oblique to thefirst retaining surface1334 as already described above with respect to the first andsecond retaining surfaces1234 and1242. However, when thearm1310 is in the second position as shown inFIG. 23, the first andsecond retaining surfaces1334 and1342 may be generally parallel to mechanically secure thecatheter108 at most any location along a length of the slot formed by the two retaining surfaces.
• As clearly shown inFIG. 23, thelock portions1360 are substantially similar to thelock portions1260 already described above. As a result, a surface of eachlock portion1360 may abut thelock member1308, e.g., abut a sleeve provided at afirst end1352 of the lock member, when thearm1310 is in the second position.
• Theretainer1306 may further includeopenings1326 to, for example, assist with placing the retainer within thebase1302. Thebody portion1330 andarm1310 may also include openings orslots1328 to assist with movement of the arm to the second position via forceps or the like.
• FIG. 24A is a bottom perspective view of theanchor1300 showing anoptional cover1325 that may be placed over theretainer1306 after thearm1310 is moved to the second or locked position. Thecover1325 may provide a smooth outer surface (as shown inFIG. 24B) to, for example, reduce stress on local tissue (e.g., skin) and limit tissue growth into theanchor1300. Thecover1325 may includetabs1327 configured to securely engage one or more of theopenings1326 orslots1328 in thebody portion1330.
• FIG. 24B illustrates a top perspective view of theanchor1300 with thecover1325 installed. As shown, the cover may include a slot to permit side loading of the cover over thecatheter108 after catheter immobilization. A corresponding slot may be provided to accommodate thelock member1308. To assist with removal of thecover1325, acutout1329 may be provided.
• FIGS. 25A-25D illustrate ananchor assembly1401 in accordance with still yet another embodiment of the invention. Theanchor assembly1401 is similar to theanchor assemblies1201 and1301 described above. For example, it includes ananchor1400 having a base1402 attachable to the skull withfasteners1404, and aretainer1406 having a body orbody portion1430 and a movable, e.g., pivoting,arm1410. Like thearm1310, thearm1410 may include anintegral pin1448 that engages a corresponding opening in abody portion1430 of theretainer1406. The arm may include afirst plate member1438 and a second plate member1440 (seeFIG. 25D) that are similar in most respects to the respective components of theanchor1300 described above. Thearm1410 is illustrated in a first or unlocked position inFIG. 25A. Theanchor assembly1401 may also include alock member1408 similar to thelock members1208 and1308 already described herein.
• Thebase1402 may also be similar in most respects to thebases1202 and1302. For example, it may define acentral opening1414 to receive theretainer1406. An inner edge of thebase1402 may further have acircumferential groove1491 formed therein. Thegroove1491 may be similar in many respects to thegroove1391 described above. For example, it may define aledge1416 upon which theretainer1406 may seat.
• Theretainer1406 may include a latch formed byflexible tabs1412 on a peripheral edge of thebody1430 of the retainer. Thetabs1412 are substantially identical to thetabs1312 already described above. Accordingly, like thelatch1212, thetabs1412 are capable of biasing theretainer1406 into thegroove1491 to generally secure the retainer to the base.
• While theretainer1406 may be secured to thebase1402 in a manner substantially identical to theretainer1306 andbase1302 already described herein, movement of thearm1410 from the first position (FIG. 25A) to a second or locked position (FIG. 25B) may be achieved as described below.
• Theretainer1406 may incorporate a lock portion configured as atab member1451 slidable within aslot1453 formed in thebody1430 of the retainer. When thetab member1451 and thelock member1408 are retracted within theslot1453 as shown inFIG. 25A, thearm1410 is moved to the first or unlocked position. However, once thecatheter108 is located between first andsecond retaining surfaces1434 and1442, thearm1410 may be moved from the first position (in which the second retaining surface is oblique to the first retaining surface as already described above with respect to thesurfaces1234 and1242) to the second or locked position illustrated inFIG. 25B. In the second position, the first andsecond retaining surfaces1434 and1442 are generally parallel to one another to secure thecatheter108 at most any location along the slot formed by the retaining surfaces.
• To move thearm1410 to the second or locked position, thetab member1451 may be slid within theslot1453 in the direction indicated inFIG. 25B. As thetab member1451 slides along theslot1453, it forces afirst end1452 of thelock member1408 into contact with a rampededge1455 of thearm1410, causing the arm, e.g., thesecond retaining surface1442, to move towards thefirst retaining surface1434. The underside of thearm1410 may further include aslot1421 to accommodate movement of the lock member as shown inFIG. 25D. When thetab member1451 reaches a location along theslot1453 corresponding to thearm1410, e.g.,second retaining surface1442, being in the desired locked position as shown inFIG. 25B, the tab member may engage a detent (not shown) formed in thebody1430. As a result, thearm1410 may be secured in the second position ofFIG. 25B.
• Thelock member108 may be withdrawn, e.g., at therapy completion, from the anchor in a manner similar to that described above with respect to theanchor1200 andlock member1208. With thelock member1408 removed from theanchor1400, thearm1410 is free to pivot back towards the first unlocked position as indicated inFIG. 25C byarrow1417, thereby releasing the retention force on thecatheter108. As a result, the catheter may be withdrawn from the burr hole via the application of a traction force represented byarrow1419.
• FIG. 25D is a bottom perspective view of theanchor1400 illustrating an exemplary configuration of thearm1410. As illustrated in this view, thesecond plate member1440 may include an extension that forms theintegral pin1448 about which thearm1410 pivots. Thesecond plate member1440 may further define theslot1421 operable to receive thefirst end1452 of thelock member1408. Theslot1421 may transform the linear movement of thetab member1451 into pivotal movement of thearm1410. The components of theassembly1401, as well as of theassembly1301, may be constructed of materials similar to those discussed elsewhere herein with respect to the corresponding components of theassembly1201.
• Anchors and anchor assemblies in accordance with embodiments of the present invention may permit anchoring of a device (such as a medical catheter or an electrical lead) relative to a portal. While such anchor assemblies may be advantageous in many applications, they may be particularly useful in medical applications wherein the anchor is subdermally located as may be the case with burr hole access procedures.
• Moreover, embodiments of the present invention provide anchor assemblies and methods that permit removal of the device at therapy completion without necessitating a separate surgical procedure. For example, the anchor assembly may include a lock member that protrudes outside of the skin such that it is capable of manipulation from outside the patient's body. As a result, the lock member may be manipulated and/or removed by the clinician to release the implanted device at therapy completion without surgery. This configuration is not limiting, however, as alternative anchor assemblies may use other mechanical and non-mechanical lock configurations. For example, the anchor assembly may utilize a magnetic latch that may be manipulated by a magnet positionable outside the skin but in close proximity to the anchor. Similarly, a lock that may be released by a remote radio or ultrasonic energy transmitter could be used.
• U.S. patent application No. ______ to Skakoon (attorney docket no. 134.02860101), filed on even date herewith, may describe various exemplary systems and methods for utilizing the components described herein.
• The complete disclosures of the patents, patent applications, patent documents, and publications cited in the Background, the Detailed Description of Exemplary Embodiments, and elsewhere herein are incorporated by reference in their entirety as if each were individually incorporated.
• Illustrative embodiments of this invention are discussed and reference has been made to possible variations within the scope of this invention. These and other variations, combinations, and modifications in the invention will be apparent to those skilled in the art without departing from the scope of the invention, and it should be understood that this invention is not limited to the illustrative embodiments set forth herein. Accordingly, the invention is to be limited only by the claims provided below and equivalents thereof.

Claims (23)

1. An implantable catheter for delivering a therapeutic agent to a body, the catheter comprising:

an elongate tubular core comprising a distal end and a proximal end, wherein the core defines a lumen extending between the distal and proximal ends, the core comprising a material selected from the group consisting of silica, quartz, and polyetheretherketone (PEEK); and

an elastomeric jacket surrounding and secured to an outer surface of the tubular core, the elastomeric jacket having a radial compliance greater than a radial compliance of the tubular core, and wherein an outer diameter of the elastomeric jacket is about 4 or more times larger than an outer diameter of the tubular core.

2. The catheter ofclaim 1, wherein the outer diameter of the elastomeric jacket is about 0.8 millimeters to about 1.2 millimeters.

3. The catheter ofclaim 1, wherein an inner diameter of the tubular core is about 80 micrometers to about 120 micrometers.

4. The catheter ofclaim 1, wherein the elastomeric jacket comprises a material selected from the group consisting of polyurethane and silicone.

5. The catheter ofclaim 1, wherein the elastomeric jacket comprises a material having a durometer of about 50 to about 60 Shore D.

6. The catheter ofclaim 1, wherein the tubular core extends beyond an end of the elastomeric jacket by a distance of about 10 millimeters or more.

7. The catheter ofclaim 6, further comprising a marker band at a distal end of the elastomeric jacket.

8. The catheter ofclaim 1, further comprising an intermediate layer of material between the tubular core and the elastomeric jacket.

9. The catheter ofclaim 8, wherein the intermediate layer comprises polyimide.

10. The catheter ofclaim 1, further comprising one or more strengthening members surround by, or embedded within, the elastomeric jacket.

11. The catheter ofclaim 10, wherein the one or more strengthening members comprise a plurality of braided members helically wound about a longitudinal length of the catheter.

12. An implantable catheter for delivering a therapeutic agent to a body, the catheter comprising:

an elongate tubular core comprising fused silica, the tubular core comprising a distal end, a proximal end, and a tubular body forming a lumen spanning between the distal and proximal ends; and

an elastomeric jacket comprising polyurethane, the jacket surrounding and secured to an outer surface of the tubular core, wherein an outer diameter of the elastomeric jacket is about 4 to about 6 times greater than an outer diameter of the tubular core.

13. The catheter ofclaim 12, wherein the body of the tubular core comprises a radial thickness of about 50 micrometers or less.

14. T]he catheter ofclaim 12, wherein the lumen of the tubular core defines a lumen diameter of about 100 micrometers.

15. The catheter ofclaim 12, wherein the elastomeric jacket terminates a distance of about 10 millimeters short of the distal end of the tubular core.

16. The catheter ofclaim 12, wherein the catheter comprises one or more locator markings.

17. The catheter ofclaim 16, wherein the one or more locator markings comprises a fluoroscopic marker band located at or near a distal end of the elastomeric jacket.

18. The catheter ofclaim 12, wherein the elastomeric jacket comprises two or more abutting tubing segments assembled to form the elastomeric jacket.

19. The catheter ofclaim 12, further comprising strengthening members surrounded by, or imbedded within, the elastomeric jacket.

20. The catheter ofclaim 19, wherein the strengthening members further comprise a plurality of first braided members helically wound in a first direction about the tubular core, and a plurality of second braided members helically wound in a second, opposite direction about the tubular core.

21. The catheter ofclaim 19, wherein the strengthening members comprise elongate fibers comprising a material selected from the group consisting of polyester, polyethylene terepthalate (PET), synthetic polymers, and liquid crystal polymers.

22. The catheter ofclaim 20, wherein the first and second braided members comprise polyethylene terepthalate (PET) fibers.

23. The catheter ofclaim 12, wherein the elastomeric jacket has a hardness of about 55 Shore D.

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