Audible And Tactile Feedback
A rotational locking mechanism for securing a catheter to a surgical implant is disclosed. The locking mechanism includes a deflectable extension extending from the surgical implant about the catheter attached to the surgical implant. The shape of the deflectable extension defines a slot therein. A connector having at least one tab extending therefrom is placed about the catheter at the point of attachment to the surgical implant. Rotation of the tubular connector brings at least one tab of the connector into contact with the slot in the deflectable extension and deflects and releases at least a portion of the slot as the connector rotates from an unlocked position to a locked position within the slot. The rotation motion secures the catheter to the surgical implant, and produces a feedback detectable by a surgeon rotating the tubular connector.
This application is a continuation in part of and claims priority from U.S. patent application Ser. No. 10/741,875, filed Dec. 19, 2003, titled Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members, which claims priority to U.S. patent application Ser. No. 60/478,763, filed Jun. 16, 2003, titled Fluid Injection Port for Adjustable Gastric Band, the disclosure of which is incorporated by reference herein. This application incorporates by reference U.S. patent application Ser. No. 10/741,875 and the following United States patent applications, all of which were filed on filed Dec. 19, 2003: application Ser. No. 10/741,127 titled Subcutaneous Injection Port For Applied Fasteners; application Ser. No. 10/741,875 titled Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members; and application Ser. No. 10/741,868 titled Subcutaneous Self Attaching Injection Port With Integral Fasteners.
FIELD OF THE INVENTIONThe present invention relates generally to medical implants, and more particularly to an attachment mechanism for use with a variety of assembleable medical implants. The invention will be disclosed in connection with, but not limited to, surgically implantable injection ports.
BACKGROUND OF THE INVENTIONImplantable medical devices are typically implanted in a patient to perform a therapeutic function for that patient. Non-limiting examples of such devices include pace makers, vascular access ports, injection ports (such as used with gastric bands) and gastric pacing devices. Such implants need to be attached, typically subcutaneously, in an appropriate place in order to function properly. It is desirable that the procedure to implant such devices be quick, easy and efficient.
It is sometimes desirable to produce a medical implant as one or more implantable elements that can be assembled in the operating room or at a surgical site on or in the patient. This is done for reasons of cost, ease of manufacture, size reduction for passage through access devices such as trocars, reducing the size of the patient's incision, and the like. For implantable devices, it is desired that assembly of the implants be free from failure to avoid later correctional surgery. For implants assembled from more than one implantable element, it is extremely desirable that the assembly be quick, easy, and correct. Surgeons frequently check and recheck their work before closing the patient to ensure adequate assembly and security of implantable elements. If the implantable components are small, visualization of the assembly through the surgeons fingers can be difficult, and may force the surgeon to do a visual scan of the assembled elements or a pull test of assembled components The additional checking and rechecking is added to the implantable element assembly time and can increase operating room time and costs. What is needed is a way to reassure the surgeon of secure assembly of implantable elements that is quick, provides feedback, doesn't involve visual checks, and can reduce operating room costs.
It is sometimes desirable to produce a medical implant as one or more implantable elements that can be assembled in the operating room or at a surgical site on or in the patient. This is done for reasons of cost, ease of manufacture, size reduction for passage through access devices such as trocars, reducing the size of the patient's incision, and the like. For implantable devices, it is desired that assembly of the implants be free from failure to avoid later correctional surgery. For implants assembled from more than one implantable element, it is extremely desirable that the assembly be quick, easy, and correct. Surgeons frequently check and recheck their work before closing the patient to ensure adequate assembly and security of implantable elements. If the implantable components are small, visualization of the assembly through the surgeons fingers can be difficult, and may force the surgeon to do a visual scan of the assembled elements or a pull test of assembled components The additional checking and rechecking is added to the implantable element assembly time and can increase operating room time and costs. What is needed is a way to reassure the surgeon of secure assembly of implantable elements that is quick, provides feedback, doesn't involve visual checks, and can reduce operating room costs.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
DETAILED DESCRIPTION OF THE INVENTIONIn the following description, like reference characters designate like or corresponding parts throughout the several views. Also, in the following description, it is to be understood that terms such as front, back, inside, outside, and the like are words of convenience and are not to be construed as limiting terms. Terminology used in this patent is not meant to be limiting insofar as devices described herein, or portions thereof, may be attached or utilized in other orientations. Referring in more detail to the drawings, an embodiment of the invention will now be described. Referring to
Injection port 2 includes septum retainer 4, septum 6 and port body 8. Injection port 2, with the integrally constructed attachment mechanism, also includes one or more fasteners 10, actuator 12 and a plurality of link members 14.
As seen in
Port body 8 includes annular rim 20, which engages the upper surface of septum 6 about an annular portion. Port body 8 is retained to septum retainer 4 by a plurality of pins 22 which are disposed through respective holes 24 formed in recesses 24a in port body 8 and which extend inwardly into respective recesses 26 formed about the bottom periphery of septum retainer 4. Pins 22 may be made of any suitable biocompatible material, such as stainless steel.
The uncompressed height of septum 6 is approximately 5 mm around the outer diameter and the uncompressed diameter is approximately 18 mm. The exposed diameter for access to reservoir 20 is approximately 14 mm. The distance between the lower surface of annular rim 20 and annular flat 18 is approximately 4 mm, such that septum 6 is compressed approximately 20% to be adequately self healing to maintain a fluid tight system under pressure and still allow a low profile.
Plate 28 is disposed in recess 16a formed in the bottom of septum retainer 4, underlying septum 6 and fluid chamber or reservoir 30. As seen in
Septum retainer 4 includes passageway 32, in fluid communication with fluid chamber 30, which is defined by fitting 34 extending from the periphery adjacent the bottom of retainer 4. Tube 36, which in the embodiment depicted, leads to an adjustable gastric band (not shown), is connected to fitting 34, being compressingly urged against annular rib 38 by connector 40, which is disposed about tube 36 and secured to port body 8 as described below. Sleeve 42 is disposed about tube 36, secured to connector 40 by annular ribs 44. Sleeve 42 relieves strain on tube 36, preventing tube 36 from kinking when loaded laterally.
Actuator 12 is secured to port body 8. Although in the embodiment depicted actuator 12 is illustrated as an annular ring rotatably supported by port body 8, actuator 12 may be any suitable configuration and supported in any suitable manner to permit actuator 12 to function to move fasteners 10 between and including deployed and undeployed positions. As seen in
Actuator 12 may rotate generally about the central axis of port body 8. In the embodiment depicted, actuator 12 may rotate through an angle of about 40 degrees, although any suitable angle may be used. In the embodiment depicted, when actuator 12 is rotated in the deploying direction, causing fasteners 10 to move to the deployed position, rotation of actuator 12 beyond the fully deployed position is limited by end 48c contacting tab 46.
A detent system is formed by a pair of spaced apart raised detent ribs 48a, 48b extending inwardly from the wall of each recess 48, and a corresponding raised rib 46b extending outwardly from tab 46. The detent system assists in preventing actuator 12 from rotation and fasteners 10 from moving out of fully retracted or fully extended fired states under vibration or incidental loads, as described below.
Actuator 12 includes a plurality of spaced apart openings or slots 54, which may be engaged by any suitable instrument to transmit the necessary torque to actuator 12 to extend fasteners 10 to the actuated position. Slots 54 are configured to be engaged by commercially available instruments, rectangular in the embodiment depicted, or by the dedicated applier described below. Port body 6 includes a plurality of recesses 56 disposed about its lower periphery which are configured to cooperate with the dedicated applier as described below.
Referring also to
To actuate the attachment mechanism, integral actuator 12 is rotated in a deploying direction, which in one embodiment as depicted is clockwise (any suitable direction configured to actuate the attachment mechanism may be used), and rib 46b passes rib 48b, which may produce an audible signal in addition to a tactile signal to the surgeon. Second end 14b of link member 14 is free to move within slot 66 during actuation, as the force that rotates fastener 10 into the extended position is transmitted to fastener 10 through the interaction between cam surface 68 of fastener 10 and actuating cam surface 70 of actuator 12. As actuator 12 rotates clockwise, actuating cam surface 70 engages and pushes against cam surface 68, rotating fastener 10 about pivot pin 22. The majority of the force from actuating cam surface 70 acts tangentially on cam surface 68, off center relative to pivot pin 22, causing fastener 10 to rotate. During actuation, end 14b of link member 14 remains free to move within slot 66, applying no driving force to rotate fastener 10.
In
In
If it is desirable to retract fasteners 10, such as to remove or reposition the implanted device, actuator 12 may be rotated in an undeploying direction, counterclockwise in one embodiment depicted. Starting with the position of actuator 12 shown in
As seen in
Referring to
Referring to
Referring to
Referring to
Tactile feedback can occur during assembly as well. During assembly, rotation of connector 40 about the tube 36 and fitting 34 requires a generally uniform rotary torque. Tactile feedback may be provided by causing a change in an attachment force or rotary torque applied to connector 40. The rotational torque increase can occur near the end of the assembly procedure and may be a suitable increase in rotational torque such as about 3% to 400% when tab 40a creates an interference with detent edge 78d. This interference creates a torque increase that rises to a maximum torque as the cantilever portion of extension 78 (containing detent edge 78d) deflects to allow passage of tab 40a. The maximum torque value may be followed by a torque drop such as immediately occurs when tab 40a rotates past detent edge 78d, and just before tab 40b car) come to a hard stop against extension 78 preventing further rotation of connector 40. The torque drop can be back to the original generally uniform torque needed to rotate connector 40 about the tube 36. Thus, during the assembly of connector 40 onto port body 6 to capture tube 36, the surgeon can experience a series of tactile and auditory events that provide indicators as to the success of the assembly or locking process, even when the assembly or locking event is obscured from visibility.
Connector 40 and extension 78 can provide protective shielding of tabs 40a, 40b to prevent unlocking 40 from forces that could induce rotation and unlocking. Additionally, the outer shape of connector 40 can be a cylindrical shape of small diameter to deflect contact forces that could induce an unlocking torque.
As mentioned previously, the attachment mechanism may be actuated by engaging slots 54 with commercially available instruments or by a dedicated applier.
As shown in
Referring to
Actuator 106 includes first and second halves 106a and 106b. Locating pins 204, illustrated as extending from actuator half 106a, fit into respective complementarily shaped openings (not illustrated) on actuator half 106b. Pins 204 may alternatively extend from actuator half 106b with the openings carried by actuator half 106a. Any suitable configuration may be used to assemble and secure actuator halves 106a and 106b together. Body half 102b includes pivot pin 114b which rotatably supports actuator 106 at one end, extending through pivot holes 116a and 116b into opening 114a. Body half 102a includes pivot pin 118b (see
Referring to
Cam 120 is retained between body portions 102a and 102b, and in one embodiment, such as that depicted can reciprocate. Cam collar 136 has spaced apart, generally flat outer surfaces 142a and 142b tracks through which 140a and 140b are formed. These surfaces 140a and 140b are disposed between guide walls 144a and 144b formed in body portions 102a and 102b. Cam collar 136 also includes oppositely facing channels 146a and 146b (see
Drive shaft 122 includes annular collar 152 which is received in slots 154a and 154b (not illustrated) formed in body halves 102a and 102b, respectively. Slots 154a and 154b rotatably support drive shaft 122. Drive shaft 122 and cam 120 are generally aligned and collinear with each other, defining the axis of the shaft portion of body 102. As cam 120 is advanced downwardly, drive shaft pin 126 follows cam tracks 140a and 140b, causing drive shaft 122 to rotate, thus converting linear motion to rotary motion. Cam return spring 128 provides a nominal return force against cam collar 136.
Flexible shaft 124 is supported by a plurality of ribs 156, formed in each body half 102a, 102b, which support the bend in flexible shaft 124 that permits the rotary motion to be transferred to actuator 132 which is disposed at an angle relative to the shaft of body 102. Flexible shaft 124 may be made of any suitable biocompatible material, such as stainless steel. In an embodiment depicted, flexible shaft 124 has a stranded construction, with a center core having multiple layers of wire wrapped thereabout. Ends 124a and 124b of flexible shaft 124 may be attached to end 122b and actuator 132, respectively, in any suitable manner which sufficiently limits rotational end play to prevent or minimize lost rotational motion. In an embodiment depicted, end 124a was overmolded into end 122b, and end 124b was press fit into actuator 132. Alternatively, end 124a could be press fit into end 122b, and end 124b overmolded into actuator 132, both could be press fit, or both could be overmolded (with a corresponding change to the configuration of locator 104 to allow assembly.
Referring to
Hub 164 includes a pair of oppositely extending tabs 172a and 172b which retain port actuator 104 to body 102 and prevent rotation. Body halves 102a and 102b include respective recesses 174a (see
Referring also to
Disc shaped member 158 also includes a pair of spaced apart cams 178a and 178b which extend outwardly and upwardly from periphery 158a of member 158.
In the embodiment depicted, locator 104 includes a pair of spaced apart cantilever arms 184a and 184b, each having rib 186a and 186b, respectively. For clarity,
In the embodiment depicted, in the non-actuated state, posts 176a and 176b are generally aligned with arms 184a and 184b, respectively, although posts 176a and 176b may be at any position that corresponds to position of the actuating feature of actuator 12, which in the embodiment depicted is openings 54. As actuator 106 is depressed, actuator 132 rotates (counterclockwise in the embodiment depicted when viewed from the bottom), advancing cams 178a and 178b such that ramps 180a and 180b contact ribs 186a and 186b, respectively, deflecting arms 184a and 184b outwardly. When surfaces 182a and 182b engage ribs 186a and 186b, arms 184a and 184b are deflected a distance sufficient to move flanges 188a and 188b to a position where they no longer extend into recesses 56 or contact ledges 56a, thus releasing injection port 2 from locator 104.
Referring also to
Actuator 106 may, as illustrated in
To use, locator 104 and a portion of 102, if necessary, is inserted through an incision by the surgeon and located in the desired position adjacent the body tissue to which the medical implant (which in the embodiment depicted is an injection port 2) is to be attached. The angle between locator 104 and body 102 allows the surgeon to visualize the site directly. With injection port 2 in position, the one or more fasteners 10 are moved from the undeployed position to the deployed position in an annular path to engage the tissue. Fasteners 10 allow injection port 2 to be secured to the tissue with a retention strength equal to or greater than when secured with sutures. Safety switch 108 is rotated about pivot pin 118, withdrawing lockout tab 194 from lower opening 196, allowing actuator 106 to be rotated about pivot pin 114. This action causes cam track 150 to move cross member 138 downward, causing cam collar 136 to rotate drive shaft 122, thereby rotating actuator 132 relative to locator 104.
Rotation of actuator 132 actuates actuator 12 by rotating it. The engagement between extension 78 and tab 96 and slots 110 and 112, respectively, prevent port body 8 from rotating, allowing relative motion between actuator 12 and port body 8.
Once actuator 106 reaches the deployed position, lockout tab 194 is urged into upper opening 198, retaining actuator 106 in the deployed position. In the embodiment depicted, spring 130 biases lockout tab 194 sufficiently to produce sound as lockout tab 194 snaps into upper opening 198, providing an audible signal that actuator 106, and therefore actuator 12 and fasteners 10 are deployed fully. As illustrated in
The attachment mechanism embodied in injection port 2 is configured to be reversible so that the medical implant, injection port 2, may be moved, such as to reposition it or remove it from the patient. To do so, with actuator 106 in the deployed position, locator 104 is placed over injection port 2, locating extension 78 and tab 96 in slots 110 and 112 so that posts 176a and 176b are engaged with recesses 54. Safety switch 108 is rotated to withdraw lockout tab 194 from upper opening 198, while the surgeon pulls up on extension 200 of actuator 106. Although cam return spring 128 urges cam collar 136 upwardly, extension 200 allows an additional return force to be applied. As cross member 138 is pulled up by cam track 150, actuator 132 rotates actuator 12, moving fasteners 10 from the deployed position to the undeployed position simultaneously, while cams 178a and 178b disengage from ribs 186a and 186b, allowing flanges 188a and 188b to engage recess 56 and ledge 56a so as to retain injection port 2 in locator 104. When actuator 106 has been moved to the undeployed position, lockout tab 194 snaps into lower opening 196, generating an audible signal that actuator 106 is undeployed fully, and injection port 2 is detached from the body tissue and may be relocated or removed.
In summary, numerous benefits have been described which result from employing the concepts of the invention. The foregoing description of one or more embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments were chosen and described in order to illustrate the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims submitted herewith. It will be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure which may be employed to implement the claimed invention. As one example of an equivalent structure which may be used, the connection device can include a deflectable extension attached to the connector, the deflectable extension deflecting as the connector is moved from an unlocked to a locked engagement with the surgical implant. As a further example of an equivalent structure which may be used, the connection device can include deflectable extension attached to the catheter, the deflectable extension moved by urging from the connector as the connector is rotated from an unlocked to a locked position. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
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21. An implantable surgical injection port having an undeployed position, and a deployed position wherein it is attached to tissue, said port comprising:
- a. a housing having a closed distal end, open proximal end and a fluid reservoir therebetween;
- b. a needle penetrable septum attached to said housing about said opening; and
- c. at least two attachment mechanisms mounted to said housing at a pivot point along an outer periphery of said housing, said attached mechanisms comprising arcuate hooks having a length extending substantially greater than 90° about said pivot point said hooks having an undeployed position and a deployed position, and an actuator configured to simultaneously move said hooks from said deployed position to said undeployed position.
22. The injection port of claim 1 wherein said housing includes at least one recessed portion at said distal end thereof for receiving a free end of said attachment mechanism when said port is in its deployed position.
23. The injection port of claim 1 wherein each said arcuate hook has length extending at least 180°.
24. The injection port of claim 1 wherein each said attachment mechanism includes a sharp free end.
25. The injection port of claim 1 further including a catheter connection tube attached to said housing and in fluid communication with said reservoir.
26. The injection port of claim 1 wherein said housing comprises titanium.
27. The injection port of claim 1 wherein said septum self seals after being punctured by a needle and the needle is withdrawn.
28. The injection port of claim 1 wherein said septum comprises silicone.
29. The injection port of claim 1 wherein said injection port includes at least three said attachment mechanisms.
30. The injection port of claim 9 wherein said attachment mechanisms are equally spaced along said outer periphery.
31. The injection port of claim 1 wherein said outer periphery of said injection port is adjacent said distal end of said housing.
32. An implantable surgical injection port having an undeployed position, and a deployed position wherein it is attached to tissue, said port comprising:
- a housing a closed distal end, a open proximal end and a fluid reservoir therebetween;
- a needle penetrable septum attached to said housing about said opening; and
- at least two attachment mechanisms mounted to said housing at a pivot point along an outer periphery of said housing, said attachment mechanisms comprising an arcuate hook pivotable with respect to said housing, said hook having length extending substantially at least 180° about said pivot point said hooks having an undeployed position and a deployed position, and an actuator configured to simultaneously move said hooks from said deployed position to said undeployed position; and
- said housing further including at least one recessed portion at said distal end thereof for receiving said free end of said attachment mechanism when said port is in its deployed position.
33. The injection port of claim 12 wherein said free end is sharp.
34. The injection port claim 12 further including a catheter connection tube attached to said housing and in fluid communication with said reservoir.
35. The injection port of claim 12 wherein said housing comprises titanium.
36. The injection port of claim 12 wherein said septum self seals after being punctured by a needle is withdrawn.
37. The injection port of claim 12 wherein said septum comprises silicone.
38. The injection port of claim 12 wherein said injection port includes at least three said attachment mechanisms.
39. The injection port of claim 12 wherein said attachment mechanisms are equally spaced along said outer periphery.
40. The injection port of claim 12 wherein said outer periphery of said injection port is adjacent said distal end of said housing.
Type: Application
Filed: Jan 27, 2010
Publication Date: May 27, 2010
Inventors: Sean P. Conlon (Shadow Hill Way, OH), Richard P. Nuchols (Loveland, OH), John V. Hunt (Cincinnati, OH), Randal T. Byrum (Milford, OH), Dale R. Schulze (Lebanon, OH)
Application Number: 12/694,303
International Classification: A61M 5/34 (20060101);